King & Spalding

New Jersey Senate Passes Law Requiring Notice Prior To Installation Of Remote Car Disabling “Payment Assurance Devices”

On December 19, 2016, the New Jersey Senate passed a bill requiring auto lenders to provide notice prior to installing “payment assurance devices” that can remotely disable an owner’s vehicle for failure to make a payment…more

Auto Lease, Automotive Industry, Automotive Loans

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Employees Expecting Tax Refunds? So Are Your Hackers

With the beginning of the 2016 tax season, employers should be on high alert for the wave of W-2 spear phishing scams coming their way once again this year. Companies that fall victim to this type of scam likely will be faced…more

Data Protection, Hackers, IRS, Phishing Scams, Tax Refunds

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Establishment of the Parallel Market of the Saudi Stock Exchange

Background - On 21 December 2016, the Capital Market Authority of Saudi Arabia (the CMA) approved the Parallel Market Listing Rules (the Rules), thereby establishing the Parallel Market, an alternative market to the Main…more

Capital Markets Authority, Financial Adviser, Foreign Financial Institutions (FFI), Saudi Arabia, Saudi Stock Exchange

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Energy Newsletter - September 2016

Implementing Islamic Financing for Renewable Energy Projects - The Middle East and North Africa (MENA) region has recently seen a surge of interest in developing renewable energy, in particular solar energy projects. Led by…more

Acquisitions, Bankruptcy Code, BOEM, Coal Industry, Covenants that Run With the Land

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Saudi Arabia’s Vision 2030 – Securing PPP Value for Money and the Criticality of Monitoring and Root Cause Analyses

Introduction - Much of the PPP debate in Saudi Arabia has focussed on the importance of shifting the public sector expenditure burden to the private sector. Wherever this has been the sole focus of a PPP programme, the…more

Contractors, Infrastructure, Oil & Gas, Private Sector, Public Private Partnerships (P3s)

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Resolution of Intercreditor Dispute in Favor of ABL Lenders in the RadioShack Bankruptcy Case

On May 11, 2016, the Delaware bankruptcy court issued an opinion in the RadioShack bankruptcy case addressing an intercreditor dispute between Salus Capital Partners, LLC, the “last out” lender in RadioShack’s prepetition $250…more

Affiliates, Bankruptcy Court, Commercial Bankruptcy, Credit Agreements, Debt Restructuring

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MEasure - Winter 2017

Amendments to Foreign Fund Private Placement Exemptions in the UAE - In August 2016, the Emirates Securities and Commodities Authority (SCA), the federal securities regulator of the United Arab Emirates (UAE), adopted new…more

Banking Sector, Debt, DIFC, Exemptions, Investment Funds

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HRSA Issues Final Rule on Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties

Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs - On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule…more

Civil Monetary Penalty, Drug Pricing, HRSA, Pharmaceutical Industry, Section 340B

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Sapin II Law: The Modernization of France's Fight Against Corruption

After years of facing international criticism for purported “laxity” towards transparency and the fight against bribery and corruption, France has adopted new legislation aiming to rectify this deficiency, which imposes…more

Anti-Corruption, Bribery, Compliance, Criminal Prosecution, France

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Tokyo Dispute Resolution & Crisis Management Newsletter – November 2016

Negotiating An In-Project Construction Dispute - Introduction - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the…more

Construction Project, Dispute Resolution, Japan

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Delaware Court of Chancery Dismisses Litigation Arising from Controller Buyout of Books-A-Million Under "MFW" Framework

On October 10, 2016, the Delaware Court of Chancery issued its decision in In re Books-A-Million, Inc. Stockholders Litigation. The decision, authored by Vice Chancellor J. Travis Laster, is important because it applies the…more

Acquisitions, Bad Faith, Board of Directors, Business Judgment Rule, Buyouts

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Cooling the Energy Bill in the Senatorial Saucer

There is an old folklore that once, over breakfast, Thomas Jefferson asked George Washington why there was a need for a Senate. Washington responded with, “Why did you just pour that coffee into your saucer, before drinking?”…more

Bipartisan Agreement, Energy Policy, Energy Sector, Energy Storage, Natural Gas

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District Court Dismisses FCA Allegations Based Upon Difference of Medical Opinion

This month, the United States District Court for the District of Utah dismissed a relator’s allegations that a cardiac surgeon and two hospitals based in Utah violated the federal False Claims Act (FCA) by billing Medicare and…more

False Claims Act (FCA), Health Care Providers, HHS, Medicaid, Medicare

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DOJ Wins Again, Blocks Anthem/Cigna Merger

On February 8, 2017, the United States District Court for the District of Columbia granted the Department of Justice, Antitrust Division’s (the “DOJ”) request for an injunction blocking Anthem’s proposed $54 billion acquisition…more

Acquisitions, CIGNA, DOJ, FTC, Health Insurance

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Franchising of Restaurants in the Gulf Cooperation Council

A number of food and beverage groups (particularly restaurant groups) access the Gulf Cooperation Council (GCC) markets through franchising arrangements. With a young and fast-growing population (many of whom spent time studying…more

Franchise Agreements, Franchise Laws, Franchises, Gulf Cooperation Council (GCC), Saudi Arabia

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Tokyo Dispute Resolution & Crisis Management Newsletter – February 2017

Product Pricing and Antitrust Law in the United States - A recent US court action by a Japanese company in respect of a competitor’s volume discounts - Introduction - The current position in the US on the rules…more

Antitrust Provisions, Competition, Drug Pricing, Japan, Pharmaceutical Industry

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Employers Are Advised to Proceed Cautiously Before Discussing Employee Recruitment and Compensation with Competitors as the DOJ and FTC Crack Down on Violations of Antitrust Laws

On October 20, 2016, the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) jointly issued Antitrust Guidance for Human Resource Professionals intended to alert those involved in hiring and…more

Antitrust Violations, Compensation, DOJ, FTC, Hiring & Firing

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D.C. Circuit Rules CFPB’s Structure Unconstitutional

In a news-making decision with significant political implications, but probably limited near-term business or legal effects, the United States Court of Appeals for the District of Columbia Circuit held on Tuesday, October 11,…more

Administrative Proceedings, Article II, Banking Sector, CFPB, Constitutional Challenges

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The Beginning of the National Bioengineered Food Disclosure Standard

In our last issue of the International Food Law Gazette, we reported on the changing legal landscape for the labeling of genetically engineered (GE) foods (more commonly referred to as genetically modified organisms, or GMO). In…more

Agricultural Sector, Bioengineering, Food Manufacturers, Genetically Engineered Seed, GMO

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2017 Financial Industry Regulatory Priorities - OCIE and FINRA Announce Examination Areas of Focus

In early January, both the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) and FINRA announced their examination priorities for 2017. As in previous years, both the SEC and FINRA share many examination…more

Broker-Dealer, Examination Priorities, Financial Services Industry, FINRA, Investment Adviser

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U.S. Wooden Bedroom Furniture Manufacturers Win Continued Relief from Unfair Imports

On January 10, the U.S. International Trade Commission (ITC) determined that revocation of the antidumping duty order on wooden bedroom furniture from China would likely lead to the continuation or recurrence of material injury…more

Anti-Dumping Duty, China, Countervailing Duties, Imports, ITC

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IRS and Treasury Issue Proposed Regulations Easing Some of the Burden of the Fractions Rule

Executive Summary On November 22, the Internal Revenue Service (“IRS”) and Treasury Department issued proposed regulations (REG-136978-12, the “Proposed Regulations”) under the “fractions rule” of Section 514(c)(9)(E) of the…more

Internal Revenue Code (IRC), IRS, Proposed Regulation, Taxable Income, U.S. Treasury

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Second Circuit Clarifies Law on Enforcement of Foreign Arbitral Awards under the New York Convention

On January 18, 2017, the United States Court of Appeals for the Second Circuit (Second Circuit) issued its decision in CBF Indústría de Gusa S/A v. AMCI Holdings, Inc., a case considering important questions on the application…more

Arbitration, Arbitration Awards, Federal Arbitration Act, International Arbitration, New York Convention

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Trade & Manufacturing - News of Note - February 2017

Commerce Extends Steel Import Monitoring and Analysis System - On January 5, the Department of Commerce (Commerce) announced the extension of the Steel Import Monitoring and Analysis (SIMA) system until March 21, 2022. The…more

AGOA, Canada, Competition, Data Reporting, Duty Free

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Second Circuit Clarifies Law on Enforcement of Foreign Arbitral Awards under the New York Convention

On January 18, 2017, the United States Court of Appeals for the Second Circuit (Second Circuit) issued its decision in CBF Indústría de Gusa S/A v. AMCI Holdings, Inc., a case considering important questions on the application…more

Arbitration, Arbitration Awards, Federal Arbitration Act, International Arbitration, New York Convention

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Washington Insight - September 2016

House Financial Services Committee Votes To Repeal And Replace Dodd-Frank - On September 13th, the House Financial Services Committee approved the Financial CHOICE Act of 2016 to repeal and replace key parts of the 2010…more

Broker-Dealer, CFPB, Class Action, Commercial Real Estate Market, Cyber Threats

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(Teil)Entwarnung für SPV-Finanzierungen – BaFin veröffentlicht Auslegungshilfe zum Abschirmungsgesetz

Die Bundesanstalt für Finanzdienstleistungsaufsicht hat am 14. Dezember 2016 die lang erwartete Auslegungshilfe zum Abschirmungsgesetz veröffentlicht. Der hierzu im Dezember 2015 veröffentlichte Konsultationsentwurf hatte zuvor…more

Banks, Borrowers, Capital Requirements Regulation (CRR), Financial Services Industry, German Banking Act

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OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule also…more

Ambulance Providers, Anti-Kickback Statute, Civil Monetary Penalty, Cost-Sharing, Deductibles

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Second Circuit Reverses District Court’s Marblegate Decision; Narrows Protections Provided to Bondholders Under Section 316(b) of Trust Indenture Act

The Trust Indenture Act of 1939 (the “TIA”) codifies a select set of requirements and prohibitions intended to protect perceived “sacred rights” of holders of public bond instruments. When the U.S. District Court for the…more

Bonds, Creditors, Financial Institutions, Section 316(b), Secured Debt

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Southern District of New York holds that intercreditor agreement allows for payment of subordinated lender’s post-petition interest prior to repayment of the outstanding principal amount of senior debt

On January 27, 2017, the United States District Court for the Southern District of New York ruled that the subordinated creditor was entitled to payment of post-petition interest prior to repayment of the senior lender’s…more

Bankruptcy Code, Banks, Chapter 7, Credit Agreements, Debt

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President Trump Issues Memorandum On “Construction Of American Pipelines” -Prioritizes U.S.-Produced “Materials And Equipment”

On January 24, 2017, President Donald J. Trump signed a slate of executive orders and presidential memoranda focused on pipeline and other infrastructure projects. Along with memoranda that specifically concern the construction…more

Dakota Access Pipeline, EPA, Executive Orders, Keystone XL Pipeline, Oil & Gas

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New OSHA Silica Rule Deadline Is Rapidly Approaching – Are You Ready?

While the Summer of 2018 may seem far away, companies should be preparing now to be ready to meet the significant new requirements of the U.S. Occupational Safety and Health Administration’s (“OSHA”) new rule for respirable…more

New Regulations, OSHA, Silica, Toxic Exposure, Workplace Hazards

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FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding…more

Draft Guidance, FDA, First Amendment, Off-Label Promotion, Pharmaceutical Industry

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Energy Newsletter - September 2016

Implementing Islamic Financing for Renewable Energy Projects - The Middle East and North Africa (MENA) region has recently seen a surge of interest in developing renewable energy, in particular solar energy projects. Led by…more

Acquisitions, Bankruptcy Code, BOEM, Coal Industry, Covenants that Run With the Land

See All Updates »

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule also…more

Ambulance Providers, Anti-Kickback Statute, Civil Monetary Penalty, Cost-Sharing, Deductibles

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Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in Spain…more

CMS, Cybersecurity, Energy Sector, EPA, EU

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Proxy Advisory Firms Issue 2017 Voting Guidelines

Proxy advisory firms Institutional Shareholder Services (ISS) and Glass, Lewis & Co. (Glass Lewis) recently issued updated proxy voting guidelines for the upcoming 2017 proxy season. Notable updates were issued by one or both…more

Glass Lewis, IPO, ISS, Overboarding, Proxy Advisors

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ITC Solicits Public Comments On MTB Petitions - 45-Day Comment Period Open Until February 24, 2017

The U.S. International Trade Commission (“ITC”) is now accepting public comments on Miscellaneous Tariff Bill (“MTB”) petitions for duty suspensions and reductions that timely were filed with the agency by December 12, 2016,…more

American Manufacturing Competitiveness Act, ITC, Manufacturers, Manufacturing Facilities, Public Comment

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Healthcare Companies Call On Trump To Promote Value-Added Healthcare

Over 100 health care companies – including providers, insurers, biopharmaceutical companies, professional associations and consumer groups – joined to write the Trump administration to urge him to “continue focusing on…more

Health Care Providers, Health Insurance, Healthcare, Healthcare Reform, Trump Administration

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DOJ Wins Again, Blocks Anthem/Cigna Merger

On February 8, 2017, the United States District Court for the District of Columbia granted the Department of Justice, Antitrust Division’s (the “DOJ”) request for an injunction blocking Anthem’s proposed $54 billion acquisition…more

Acquisitions, CIGNA, DOJ, FTC, Health Insurance

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OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule also…more

Ambulance Providers, Anti-Kickback Statute, Civil Monetary Penalty, Cost-Sharing, Deductibles

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D.C. Circuit Rules CFPB’s Structure Unconstitutional

In a news-making decision with significant political implications, but probably limited near-term business or legal effects, the United States Court of Appeals for the District of Columbia Circuit held on Tuesday, October 11,…more

Administrative Proceedings, Article II, Banking Sector, CFPB, Constitutional Challenges

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Loss of Foreign Fund Private Placement Exemptions in the UAE

In August 2016, the Emirates Securities and Commodities Authority (SCA), the federal securities regulator of the United Arab Emirates (UAE), adopted new investment funds regulations (the 2016 Fund Regulations), which repealed…more

Investment Funds, Private Placements, Reverse Solicitation, Securities and Commodities Authority (SCA), United Arab Emirates

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Energy Newsletter - October 2016

Negotiating an In-Project Construction Dispute - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the project schedule or costs,…more

Construction Contracts, Construction Industry, Construction Project, De Novo Standard of Review, Due Process

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Overview of REMIT for LNG Sellers to EU

With a robust demand for gas and a desire to reduce its reliance on Russian gas supplies, Europe is a market hotly pursued by liquefied natural gas (“LNG”) sellers and export project developers alike. Those seeking to sell to…more

Energy Sector, EU, Liquid Natural Gas, Oil & Gas, REMIT

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Standing In Data Breach Class Actions: The Fourth Circuit Weighs In, Affirming Dismissal For Lack Of Subject Matter Jurisdiction

The U.S. Court of Appeals for the Fourth Circuit issued a unanimous opinion in Beck v. McDonaldon February 6, 2017, clarifying the standard for Article III standing and what constitutes sufficient injury-in-fact in putative data…more

Administrative Procedure Act, Article III, Class Action, Confidential Information, Data Breach

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American Iron & Steel Requirement At Issue In Water Infrastructure Legislation

In the early hours of December 10, after weeks of intense negotiations between House and Senate conferees, the Senate voted to send a final package containing Water Resources Development Act (WRDA) language to the President’s…more

Drinking Water, EPA, Infrastructure, Steel Industry, Water

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Proxy Advisory Firms Issue 2017 Voting Guidelines

Proxy advisory firms Institutional Shareholder Services (ISS) and Glass, Lewis & Co. (Glass Lewis) recently issued updated proxy voting guidelines for the upcoming 2017 proxy season. Notable updates were issued by one or both…more

Glass Lewis, IPO, ISS, Overboarding, Proxy Advisors

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Substance Abuse and Mental Health Services Administration (SAMHSA) Issues Confidentiality of Alcohol and Drug Abuse Patient Records Regulations

On January 13, 2017, SAMHSA issued a Final Rule updating the Confidentiality of Alcohol and Drug Abuse Patient Records regulations (42 C.F.R. Part 2). SAMHSA also issued a Supplemental Proposed Rule requesting comments on…more

Confidentiality Policies, Data Security, Drug & Alcohol Abuse, Electronic Medical Records, Mental Health

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The Small Matter of Bankability: Small-Modular-Reactors and the Financing of Nuclear Projects

The nuclear industry in the UK, and beyond, will warmly welcome EDF’s final investment decision for Hinkley Point C. However, as the UK government mulls over the project fundamentals one last time before committing, it is worth…more

Construction Project, Nuclear Power, Renewable Energy Investments, UK

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Digesting the €13 Billion Apple-EU Tax Ruling

King & Spalding experts assess what international businesses need to be aware of following the EC's ruling on State Aid in the Apple case - Partners in King & Spalding’s tax department have shared their perspectives and…more

Apple, Corporate Taxes, EU, European Commission, Ireland

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Global Investigations Review Conference Highlights the Future of Anti-Corruption Enforcement Recapping GIR Live DC

On February 16, 2017, Global Investigations Review (“GIR”) held its second annual GIR Live DC in Washington, D.C. With an emphasis on global anticorruption enforcement, the event featured a variety of experts in complex,…more

Anti-Bribery, Anti-Corruption, Confidential Information, DOJ, FCPA

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Final Rule for Penalties Relating to 340B Drug Pricing Program Nears Release

On December 23, 2016, the White House Office of Management and Budget (OMB) completed review of a final rule for penalties under the 340B Drug Pricing Program for drug manufacturers that intentionally charge a 340B covered…more

Drug Pricing, Final Rules, HHS, Manufacturers, Pharmaceutical Industry

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2017 Financial Industry Regulatory Priorities - OCIE and FINRA Announce Examination Areas of Focus

In early January, both the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) and FINRA announced their examination priorities for 2017. As in previous years, both the SEC and FINRA share many examination…more

Broker-Dealer, Examination Priorities, Financial Services Industry, FINRA, Investment Adviser

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Compensation and Benefits Insights – September 2016 #2

Hardly Water Under the Bridge: NLRB, SEC, OSHA Mount Offensive Against Confidentiality Agreements - A recent New York Times story shed light on complaints by an employee of Bridgewater Associates, a $154 billion hedge fund…more

Confidential Information, Deadlines, DOL, ERISA, Health and Welfare Plans

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Delaware Court of Chancery Dismisses Litigation Arising from Controller Buyout of Books-A-Million Under "MFW" Framework

On October 10, 2016, the Delaware Court of Chancery issued its decision in In re Books-A-Million, Inc. Stockholders Litigation. The decision, authored by Vice Chancellor J. Travis Laster, is important because it applies the…more

Acquisitions, Bad Faith, Board of Directors, Business Judgment Rule, Buyouts

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Vizio Pays $2.2 Million To Settle With The FTC Over Its Data Collection And Sharing Practices

On February 6, 2017, Vizio Inc., a manufacturer and seller of internet-connected “smart” televisions, agreed to pay $2.2 million to settle allegations by the Federal Trade Commission (“FTC”) and the Office of the New Jersey…more

Data Collection, Disclosure Requirements, FTC, Personal Data, Prior Express Consent

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LinkedIn Blocked in Russia: Privacy and Trade Law Aspect

The business networking platform LinkedIn is the first major international player to fall victim to the implementation of Russia’s “data localization” law, with effect from September 1, 2015, which requires all parties…more

Blocked Entities, Cross-Border Transactions, Data Localisation Law, GATS, Internet Service Providers (ISPs)

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Implementing A Competitive Natural Gas Market In Mexico - CENAGAS to hold its first open season

Centro Nacional de Control de Gas Natural (CENAGAS) has received authorization from the Comisión Reguladora de Energía (CRE) to conduct its first open season for the assignment of available capacity on a firm basis in the…more

Competitive Bidding, Deadlines, Electricity, Energy Sector, Foreign Investment

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2017 Financial Industry Regulatory Priorities - OCIE and FINRA Announce Examination Areas of Focus

In early January, both the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) and FINRA announced their examination priorities for 2017. As in previous years, both the SEC and FINRA share many examination…more

Broker-Dealer, Examination Priorities, Financial Services Industry, FINRA, Investment Adviser

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Southern District of New York holds that intercreditor agreement allows for payment of subordinated lender’s post-petition interest prior to repayment of the outstanding principal amount of senior debt

On January 27, 2017, the United States District Court for the Southern District of New York ruled that the subordinated creditor was entitled to payment of post-petition interest prior to repayment of the senior lender’s…more

Bankruptcy Code, Banks, Chapter 7, Credit Agreements, Debt

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Energy Newsletter - October 2016

Negotiating an In-Project Construction Dispute - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the project schedule or costs,…more

Construction Contracts, Construction Industry, Construction Project, De Novo Standard of Review, Due Process

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Briseno v. ConAgra Foods, Inc.: Ninth Circuit Rules That There Need Not Be An Administratively Feasible Way To Identify Class Members In GMO Natural Case

In Briseno v. ConAgra Foods, Inc., an opinion issued on January 3, 2017, the United States Court of Appeals for the Ninth Circuit held that Federal Rule of Civil Procedure 23 does not require plaintiffs challenging the labeling…more

All Natural, Class Action, Federal Rules of Civil Procedure, Food Labeling, GMO

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ITC Section 337 Update – October 2016

Commission Suspends ‘939 Investigation Enforcement Pending PTAB Result - On July 21, 2016, the International Trade Commission (“the Commission”) issued a notice that it had found a violation of Section 337 in Certain Cinema…more

ALJ, Anti-Dumping Duty, ITC, Patent Infringement, Patent Litigation

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LNG In Morocco

Morocco is currently implementing important changes to its energy mix, which may provide interesting opportunities in the LNG sector. This article presents a brief overview of the origin of the national development plan for LNG…more

Electricity, Energy Projects, Energy Sector, Hydropower, Intended Nationally Determined Contributions (INDC)

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Carrier Reaches Agreement to Keep Some Manufacturing Jobs In Indiana

On December 1, President-elect Donald Trump, alongside Vice President-elect, and current Indiana Governor, Mike Pence, appeared at a Carrier Corporation plant in Indianapolis to announce that the company would keep roughly 800…more

Manufacturers, Presidential Elections, Trump Administration

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Southern District of New York holds that intercreditor agreement allows for payment of subordinated lender’s post-petition interest prior to repayment of the outstanding principal amount of senior debt

On January 27, 2017, the United States District Court for the Southern District of New York ruled that the subordinated creditor was entitled to payment of post-petition interest prior to repayment of the senior lender’s…more

Bankruptcy Code, Banks, Chapter 7, Credit Agreements, Debt

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FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding…more

Draft Guidance, FDA, First Amendment, Off-Label Promotion, Pharmaceutical Industry

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In Salman v. United States, Supreme Court Holds that the Government Need Not Prove that an Insider Received a Pecuniary Benefit in Exchange for Tipping Inside Information

On December 6, 2016, the Supreme Court issued a unanimous decision in Salman v. United States, holding that a tipper’s gift of confidential, inside information to a trading relative constituted a sufficient personal benefit to…more

Confidential Information, Dirks v SEC, Fiduciary Duty, Financial Markets, Illegal Tipping

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Compensation and Benefits Insights – September 2016

New Guidance Affects Wellness Program Design - Over the last several months, the Equal Employment Opportunity Commission (“EEOC”) and the Internal Revenue Service (“IRS”) have provided additional guidance regarding the…more

Acquisitions, ADA, Audits, Benefit Plan Sponsors, Compensation & Benefits

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NY DFS’s Revised Cybersecurity Rules Are More Flexible, Still Mandatory For Banks And Financial Institutions

On December 28, 2016, the New York Department of Financial Services (“DFS”) issued a revised version of its proposed cybersecurity rule for banks, insurers, money service businesses, and regulated virtual currency operators who…more

Cybersecurity, Department of Financial Services, Financial Institutions, Proposed Rules

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President Trump Issues Memorandum On “Construction Of American Pipelines” -Prioritizes U.S.-Produced “Materials And Equipment”

On January 24, 2017, President Donald J. Trump signed a slate of executive orders and presidential memoranda focused on pipeline and other infrastructure projects. Along with memoranda that specifically concern the construction…more

Dakota Access Pipeline, EPA, Executive Orders, Keystone XL Pipeline, Oil & Gas

See All Updates »

Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in Spain…more

CMS, Cybersecurity, Energy Sector, EPA, EU

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The Senior Managers Regime – should GCs be worried?

In March this year the PRA and the FCA introduced the Senior Managers Regime (‘SMR’) for individuals associated with banks and PRA regulated investment firms (from 2018 the SMR will apply to all UK authorised firms). The regime…more

Banks, Corporate Counsel, Financial Conduct Authority (FCA), Individual Accountability, Investment Firms

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Federal Court Blocks Anthem - Cigna Merger; King & Spalding Looks Deeper into Aetna-Humana Challenge

On February 8, 2017, the United States District Court for the District of Columbia granted a request filed by the U.S. Department of Justice’s Antitrust Division for an injunction blocking Anthem, Inc.’s (Anthem) proposed $54…more

Acquisitions, Aetna, Anthem Insurance, Antitrust Division, CIGNA

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Investment Treaty Arbitration: How Multinationals Can Structure Their Investments to Obtain Treaty Protection

In a previous article, we explained how a U.S.-based company that had established a subsidiary abroad could benefit from protections against unfair conduct of a foreign State that are found in most bilateral investment treaties…more

Arbitration, Bilateral Investment Treaties, Foreign Subsidiaries, International Arbitration, Multinationals

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Brexit: UK Government Publishes EU Exit Plan - Official policy document outlines agenda on laws, workers’ rights, trade and free movement of people

The UK Government published its long-awaited official policy document on Brexit – the UK’s withdrawal from the European Union (EU) – on 2 February, 2017, which outlined many of its goals for the Brexit process. The…more

Corporate Counsel, EU, EU Single Market, Free Movement, Free Trade Agreements

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CMS Updates Manual Guidance to Include References to the Two Midnight Rule

Although the Two Midnight Rule was effective October 1, 2013, until recently, CMS had not updated the Medicare Benefit Policy Manual (MBPM) to incorporate the Two Midnight Rule and its revisions to prior admission requirements. …more

CMS, Medicare, Medicare Benefit Policy Manual, Two-Midnight Rule

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Tax Reform Considerations for REITs

Various components of the tax reform proposals that have been put forth by the Congress as well as the President could have significant impacts on REITs. In 2016, the Republican leadership and Republicans on the House Committee…more

Corporate Taxes, Interest Rates, Like Kind Exchanges, REIT, Tax Reform

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FinCEN Issues Advisory on Jurisdictions with AML/CFT Deficiencies

The Financial Crimes Enforcement Network (“FinCEN”), an agency within the U.S. Treasury Department, has put forth an Advisory on the FATFIdentified Jurisdictions with AML/CFT (Anti-Money Laundering/Combating the Financing of…more

AML/CFT, EDD, FATF, Financial Institutions, FinCEN

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NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises implications for software manufacturers and suppliers

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s…more

Automation Systems, Enforcement, Final Guidance, Motor Vehicles, NHTSA

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Meyers v. Nicolet Restaurant of De Pere, LLC: Seventh Circuit Rules Mere Failure to Truncate Credit Card Expiration Date Under FACTA Insufficient to Confer Article III Standing.

In Meyers v. Nicolet Restaurant of De Pere, LLC, an opinion issued on December 13, 2016, the United States Court of Appeals for the Seventh Circuit held that a proposed class action suit brought under the Fair and Accurate…more

Article III, Class Action, Debit and Credit Card Transactions, FACTA, Injury-in-Fact

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HRSA Withdraws 340B Program “Mega Guidance” from OMB Review

On January 30, 2017, the Health Resources and Services Administration (HRSA) withdrew its 340B Program Omnibus Guidelines (Guidelines) from regulatory review by the Office of Management and Budget (OMB). HRSA published the…more

HHS, HRSA, Omnibus Guidance, Proposed Rules, Section 340B

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November and December 2016 Filing and Notice Deadlines for Qualified Retirement and Health and Welfare Plans

Employers and plan sponsors must comply with numerous filing and notice deadlines for their retirement and health and welfare plans. Failure to comply with these deadlines can result in costly penalties. To avoid such…more

Benefit Plan Sponsors, ERISA, Filing Deadlines, Health and Welfare Plans, IRS

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Sapin II Law: The Modernization of France's Fight Against Corruption

After years of facing international criticism for purported “laxity” towards transparency and the fight against bribery and corruption, France has adopted new legislation aiming to rectify this deficiency, which imposes…more

Anti-Corruption, Bribery, Compliance, Criminal Prosecution, France

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President Trump Issues Memorandum On “Construction Of American Pipelines” -Prioritizes U.S.-Produced “Materials And Equipment”

On January 24, 2017, President Donald J. Trump signed a slate of executive orders and presidential memoranda focused on pipeline and other infrastructure projects. Along with memoranda that specifically concern the construction…more

Dakota Access Pipeline, EPA, Executive Orders, Keystone XL Pipeline, Oil & Gas

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DHS Designates Election Infrastructure As “Critical” Amid Cybersecurity Concerns

In a January 6, 2017 statement, Secretary of Homeland Security Jeh Johnson announced that election infrastructure in the United States has been designated “critical” and worthy of the Department of Homeland Security’s (“DHS”)…more

Critical Infrastructure Sectors, Cybersecurity, DHS, Infrastructure

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Timely Reminders to Avoid Inadvertent Tipping Liability

Just in time for the annual season of work holiday parties and family gatherings, the United States Supreme Court unanimously confirmed that leaking material non-public information to a close relative who then trades in…more

Confidential Information, Illegal Tipping, Insider Trading, Non-Public Information, Personal Benefit

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Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to Communications Addressed to HCPs

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications…more

Advertising, EU, European Court of Justice (ECJ), Food Manufacturers, Food Marketing

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Proposed German Law Could Curtail Privacy Rights

Although Germany has tended to advocate relatively strict data protection laws, a recently released draft law could call into question the extent to which Germany will protect privacy rights in the future. The stated purpose of…more

Data Collection, Data Protection, EU, Germany, Right to Privacy

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Implementing A Competitive Natural Gas Market In Mexico - CENAGAS to hold its first open season

Centro Nacional de Control de Gas Natural (CENAGAS) has received authorization from the Comisión Reguladora de Energía (CRE) to conduct its first open season for the assignment of available capacity on a firm basis in the…more

Competitive Bidding, Deadlines, Electricity, Energy Sector, Foreign Investment

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United States And Switzerland Reach Data Transfer Agreement

On January 11, 2017, the governments of the United States and Switzerland announced that an agreement had been reached over a Privacy Shield Framework (“Privacy Shield”) that sets out how companies may transfer personal data…more

Data Protection, EU, EU-US Privacy Shield, International Data Transfers, Personal Data

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Second Circuit Reverses District Court’s Marblegate Decision; Narrows Protections Provided to Bondholders Under Section 316(b) of Trust Indenture Act

The Trust Indenture Act of 1939 (the “TIA”) codifies a select set of requirements and prohibitions intended to protect perceived “sacred rights” of holders of public bond instruments. When the U.S. District Court for the…more

Bonds, Creditors, Financial Institutions, Section 316(b), Secured Debt

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Timely Reminders to Avoid Inadvertent Tipping Liability

Just in time for the annual season of work holiday parties and family gatherings, the United States Supreme Court unanimously confirmed that leaking material non-public information to a close relative who then trades in…more

Confidential Information, Illegal Tipping, Insider Trading, Non-Public Information, Personal Benefit

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LNG In Morocco

Morocco is currently implementing important changes to its energy mix, which may provide interesting opportunities in the LNG sector. This article presents a brief overview of the origin of the national development plan for LNG…more

Electricity, Energy Projects, Energy Sector, Hydropower, Intended Nationally Determined Contributions (INDC)

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EU-U.S. Privacy Shield: Assessing The New Regime

Businesses have now had four months to get to grips with the new EU-U.S. Privacy Shield for transatlantic data transfers after it came into force in August 2016. As the New Year looms, what are the emerging trends we have seen…more

Data Privacy, Data Protection Authority, EU, EU-US Privacy Shield, European Commission

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ITC Section 337 Update – August 2016

DeLorme Seeks Certiorari Review Of Consent Order Penalty Based On Expired Patent — On July 13, 2016, DBN Holding, Inc. and BDN LLC (“DeLorme”) filed a petition for writ of certiorari to review a judgment of the United States…more

Anti-Dumping Duty, Appeals, Component Parts Doctrine, Consent Order, Countervailing Duties

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FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed Tests…more

CLIA, CMS, Draft Guidance, FDA, Laboratory Developed Tests

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DOT Releases Autonomous Vehicles Guidelines - New AV Policy Sets a Course for Safety and Oversight

The highly anticipated Federal Automated Vehicles Policy (AV Policy), released yesterday, provides manufacturers direction on developing safer autonomous cars. In addition, NHTSA has presented a model guide for states on their…more

Automotive Industry, Department of Transportation (DOT), Driverless Cars, Motor Vehicles, NHTSA

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Third Circuit Rules Make-Whole Provisions Enforceable in the Energy Future Bankruptcy

On November 17, the U.S. Court of Appeals for the Third Circuit (the “Court”) made clear its stance on the question of enforceability of make-whole provisions in bankruptcy. Bucking the recent trend seen in cases such as In re…more

Appeals, Bankruptcy Court, Borrowers, Commercial Bankruptcy, Debt

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Meaning of “Commencement of Drilling”: Summary of Vitol E & P Limited v Africa Oil and Gas Corporation [2016] EWHC 1677 (Comm)

Introduction - In a dispute arising in connection with a sale and purchase agreement for an interest under a Production Sharing Contract in the Congo, an English court (the Queen's Bench Division of the High Court of…more

Acquisitions, Africa, Contract Disputes, Deferred Consideration, Democratic Republic of Congo

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Oncology Practice Agrees to Pay $5.3 Million to Settle Copayment Waiver Case

A New York State hematology-oncology medical practice (the Practice), has agreed to pay $5.3 million to resolve allegations that, over an approximate five-year period, it provided kickbacks to patients in the form of waived…more

Co-payments, Healthcare, HHS, Kickbacks, OIG

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SEC Cracks Down on Charitable Contributions under the FCPA - Best Practices In Light of Recent SEC Enforcement

For the first time, the Securities and Exchange Commission has brought an FCPA enforcement action premised entirely on a one-time charitable contribution. On September 20, 2016, the SEC announced a settled FCPA…more

Bribery, Charitable Donations, Charitable Organizations, China, Corruption

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Forewarned is Forearmed—Hosting Events at the Political Conventions

Organizations that plan to provide entertainment to Members and staff of the United States House of Representatives and Senate at the political party conventions should remind themselves of the unique rules that apply to…more

Campaign Contributions, Lobbying, Lobbying Disclosure Act, Lobbyists

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Tokyo Dispute Resolution & Crisis Management Newsletter – December 2016

Major FCPA Enforcement Action - Including charges against the CEO and CFO for failing to prevent misconduct - In one of the largest FCPA settlements in history, hedge fund Och-Ziff Capital Management Group LLC…more

CEOs, Democratic Republic of Congo, Enforcement Actions, FCPA, Hedge Funds

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Overview of REMIT for LNG Sellers to EU

With a robust demand for gas and a desire to reduce its reliance on Russian gas supplies, Europe is a market hotly pursued by liquefied natural gas (“LNG”) sellers and export project developers alike. Those seeking to sell to…more

Energy Sector, EU, Liquid Natural Gas, Oil & Gas, REMIT

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NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises implications for software manufacturers and suppliers

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s…more

Automation Systems, Enforcement, Final Guidance, Motor Vehicles, NHTSA

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2017 Financial Industry Regulatory Priorities - OCIE and FINRA Announce Examination Areas of Focus

In early January, both the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) and FINRA announced their examination priorities for 2017. As in previous years, both the SEC and FINRA share many examination…more

Broker-Dealer, Examination Priorities, Financial Services Industry, FINRA, Investment Adviser

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Franchising of Restaurants in the Gulf Cooperation Council

A number of food and beverage groups (particularly restaurant groups) access the Gulf Cooperation Council (GCC) markets through franchising arrangements. With a young and fast-growing population (many of whom spent time studying…more

Franchise Agreements, Franchise Laws, Franchises, Gulf Cooperation Council (GCC), Saudi Arabia

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Timely Reminders to Avoid Inadvertent Tipping Liability

Just in time for the annual season of work holiday parties and family gatherings, the United States Supreme Court unanimously confirmed that leaking material non-public information to a close relative who then trades in…more

Confidential Information, Illegal Tipping, Insider Trading, Non-Public Information, Personal Benefit

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Judge Denies HHS’s Request to Rescind Timeline to Eliminate the Medicare Appeals Backlog

On January 4, 2017, the court in the American Hospital Association (AHA) v. Burwell litigation denied HHS’s motion to reconsider, which means that HHS must comply with the court’s timeline to eliminate the Medicare appeals…more

American Hospital Association, Appeals, HHS, Hospitals, Medicare

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2017 Financial Industry Regulatory Priorities - OCIE and FINRA Announce Examination Areas of Focus

In early January, both the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) and FINRA announced their examination priorities for 2017. As in previous years, both the SEC and FINRA share many examination…more

Broker-Dealer, Examination Priorities, Financial Services Industry, FINRA, Investment Adviser

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Tax Reform Considerations for REITs

Various components of the tax reform proposals that have been put forth by the Congress as well as the President could have significant impacts on REITs. In 2016, the Republican leadership and Republicans on the House Committee…more

Corporate Taxes, Interest Rates, Like Kind Exchanges, REIT, Tax Reform

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New Obama Administration Employment-based Visa Rule and Trump's Plan to Target Visa Abuse Create Uncertainty For Employers

President-elect Trump made enforcement of immigration laws a centerpiece of his campaign. On November 21, 2016, Mr. Trump stated that he will make investigation of abuses in “visa programs that undercut the American worker” a…more

DHS, DOL, Enforcement, H-1B, Presidential Elections

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Tokyo Dispute Resolution & Crisis Management Newsletter – September 2016

A Sleeping Sword – Protection for Japanese Corporations Investing Outside of Japan - A Guide to International Investment Agreements - Introduction - Over the past twenty years, International Investment…more

Bilateral Investment Treaties, Foreign Investment, Free Trade Agreements, Investment Companies, Investor State Dispute Settlement (ISDS)

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Tokyo Dispute Resolution & Crisis Management Newsletter – December 2016

Major FCPA Enforcement Action - Including charges against the CEO and CFO for failing to prevent misconduct - In one of the largest FCPA settlements in history, hedge fund Och-Ziff Capital Management Group LLC…more

CEOs, Democratic Republic of Congo, Enforcement Actions, FCPA, Hedge Funds

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How to Prepare for the Significant Changes to U.S. Trade Policy under President Donald Trump

On Tuesday, November 8, 2016, Donald Trump was elected President of the United States after a campaign in which he repeatedly criticized long-standing principles of U.S. trade policy. Mr. Trump’s victory is likely to lead to a…more

Bipartisan Agreement, China, Dispute Resolution, Enforcement, NAFTA

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Energy Newsletter - October 2016

Negotiating an In-Project Construction Dispute - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the project schedule or costs,…more

Construction Contracts, Construction Industry, Construction Project, De Novo Standard of Review, Due Process

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Southern District of New York holds that intercreditor agreement allows for payment of subordinated lender’s post-petition interest prior to repayment of the outstanding principal amount of senior debt

On January 27, 2017, the United States District Court for the Southern District of New York ruled that the subordinated creditor was entitled to payment of post-petition interest prior to repayment of the senior lender’s…more

Bankruptcy Code, Banks, Chapter 7, Credit Agreements, Debt

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Brexit Trade Audit: A Five-Step Guide to Help Determine the Way Forward

Companies doing business in the UK or from the UK should be looking to “future-proof” their operations following the UK’s recent vote to leave the European Union. A Brexit audit is one way of determining the possible impact of…more

Audits, EU, Goods or Services, Imports, Member State

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Establishment of the Parallel Market of the Saudi Stock Exchange

Background - On 21 December 2016, the Capital Market Authority of Saudi Arabia (the CMA) approved the Parallel Market Listing Rules (the Rules), thereby establishing the Parallel Market, an alternative market to the Main…more

Capital Markets Authority, Financial Adviser, Foreign Financial Institutions (FFI), Saudi Arabia, Saudi Stock Exchange

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ITC Section 337 Update – August 2016

DeLorme Seeks Certiorari Review Of Consent Order Penalty Based On Expired Patent — On July 13, 2016, DBN Holding, Inc. and BDN LLC (“DeLorme”) filed a petition for writ of certiorari to review a judgment of the United States…more

Anti-Dumping Duty, Appeals, Component Parts Doctrine, Consent Order, Countervailing Duties

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Washington Insight - September 2016

House Financial Services Committee Votes To Repeal And Replace Dodd-Frank - On September 13th, the House Financial Services Committee approved the Financial CHOICE Act of 2016 to repeal and replace key parts of the 2010…more

Broker-Dealer, CFPB, Class Action, Commercial Real Estate Market, Cyber Threats

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Price Confirmed as HHS Secretary; Hearing Scheduled on Verma Nomination

Early in the morning of February 10, 2017, the U.S. Senate confirmed Rep. Tom Price (R-GA) to be the Secretary of Health and Human Services. Senators voted along party lines, 52 to 47, to confirm Rep. Price, an orthopedic…more

Affordable Care Act, Healthcare Reform, HHS, Secretary of HHS, Trump Administration

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TC Heartland v. Kraft: Awaiting a 2017 Supreme Court Decision with Potentially Significant Implications for Patent Litigation

Patent litigation continues to be concentrated in a small number of venues. Of the 4530 patent cases filed in 2016, for example, patentees chose the Eastern District of Texas more than one third of the time (1661 cases). In…more

Certiorari, Corporate Liability, Forum Shopping, Patent Infringement, Patent Litigation

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(Teil)Entwarnung für SPV-Finanzierungen – BaFin veröffentlicht Auslegungshilfe zum Abschirmungsgesetz

Die Bundesanstalt für Finanzdienstleistungsaufsicht hat am 14. Dezember 2016 die lang erwartete Auslegungshilfe zum Abschirmungsgesetz veröffentlicht. Der hierzu im Dezember 2015 veröffentlichte Konsultationsentwurf hatte zuvor…more

Banks, Borrowers, Capital Requirements Regulation (CRR), Financial Services Industry, German Banking Act

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Washington Insight - September 2016

House Financial Services Committee Votes To Repeal And Replace Dodd-Frank - On September 13th, the House Financial Services Committee approved the Financial CHOICE Act of 2016 to repeal and replace key parts of the 2010…more

Broker-Dealer, CFPB, Class Action, Commercial Real Estate Market, Cyber Threats

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CMS Finalizes Policies on Off-Campus Provider-Based Status CMS Will Pay Non-Excepted PBDs in 2017, But Adopts Nearly All Other Proposals

On November 1, 2016, the Centers for Medicare & Medicaid Services (CMS) issued its CY 2017 Outpatient Prospective Payment System (OPPS) Final Rule, which includes the agency’s final policies implementing legislative changes to…more

Bipartisan Budget Act, CMS, Health Care Providers, Hospitals, Off-Campus Departments

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2017 Financial Industry Regulatory Priorities - OCIE and FINRA Announce Examination Areas of Focus

In early January, both the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) and FINRA announced their examination priorities for 2017. As in previous years, both the SEC and FINRA share many examination…more

Broker-Dealer, Examination Priorities, Financial Services Industry, FINRA, Investment Adviser

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Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to Communications Addressed to HCPs

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications…more

Advertising, EU, European Court of Justice (ECJ), Food Manufacturers, Food Marketing

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Brexit: UK Government Publishes EU Exit Plan - Official policy document outlines agenda on laws, workers’ rights, trade and free movement of people

The UK Government published its long-awaited official policy document on Brexit – the UK’s withdrawal from the European Union (EU) – on 2 February, 2017, which outlined many of its goals for the Brexit process. The…more

Corporate Counsel, EU, EU Single Market, Free Movement, Free Trade Agreements

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International Cybersecurity Accord Adopted By Major World Economies

The Group of 7, comprised of Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States, adopted a non-binding agreement aimed at strengthening the cybersecurity and resiliency of the international…more

Cybersecurity, Financial Institutions, Financial Sector

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2017 Financial Industry Regulatory Priorities - OCIE and FINRA Announce Examination Areas of Focus

In early January, both the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) and FINRA announced their examination priorities for 2017. As in previous years, both the SEC and FINRA share many examination…more

Broker-Dealer, Examination Priorities, Financial Services Industry, FINRA, Investment Adviser

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Proxy Advisory Firms Issue 2017 Voting Guidelines

Proxy advisory firms Institutional Shareholder Services (ISS) and Glass, Lewis & Co. (Glass Lewis) recently issued updated proxy voting guidelines for the upcoming 2017 proxy season. Notable updates were issued by one or both…more

Glass Lewis, IPO, ISS, Overboarding, Proxy Advisors

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Building a Favorable Project Record During Construction Disputes

The value and importance of the written record in a dispute arising from a major construction project cannot be overstated. Even when project personnel are available to provide first-hand accounts—which often is challenging…more

Construction Contracts, Construction Disputes, Construction Industry, Construction Project, General Contractors

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Saudi Arabia’s Vision 2030 – Securing PPP Value for Money and the Criticality of Monitoring and Root Cause Analyses

Introduction - Much of the PPP debate in Saudi Arabia has focussed on the importance of shifting the public sector expenditure burden to the private sector. Wherever this has been the sole focus of a PPP programme, the…more

Contractors, Infrastructure, Oil & Gas, Private Sector, Public Private Partnerships (P3s)

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Energy Newsletter - October 2016

Negotiating an In-Project Construction Dispute - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the project schedule or costs,…more

Construction Contracts, Construction Industry, Construction Project, De Novo Standard of Review, Due Process

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Tokyo Dispute Resolution & Crisis Management Newsletter – January 2017

Managing Risks in Acquisitions from Financially Challenged Sellers in the Resources & Energy Sector - Low Commodity Prices - After a decade long boom in the resources and energy sector, prices across almost all…more

Acquisitions, Due Diligence, Energy Sector, Escrow Accounts, Insolvency

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HHS OIG Issues Final Regulation Addressing Exclusion Authority

On January 12, 2017, the HHS OIG issued its final rule amending regulations relating to its authority under the Affordable Care Act (ACA) to exclude individuals and entities from participation in federal healthcare programs…more

Affordable Care Act, False Claims Act (FCA), Healthcare, HHS, OIG

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FERC Proposes New Data Collection Rules

On July 21, 2016, the Federal Energy Regulatory Commission (“FERC”) issued a notice of proposed rulemaking (the “NOPR”) addressing the collection of certain data from sellers making sales at market-based rates (“MBR Sellers”)…more

Connected Entities, Data Collection, Databases, Federal Register, FERC

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HRSA Issues Final Rule on Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties

Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs - On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule…more

Civil Monetary Penalty, Drug Pricing, HRSA, Pharmaceutical Industry, Section 340B

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IRS and Treasury Issue Proposed Regulations Easing Some of the Burden of the Fractions Rule

Executive Summary On November 22, the Internal Revenue Service (“IRS”) and Treasury Department issued proposed regulations (REG-136978-12, the “Proposed Regulations”) under the “fractions rule” of Section 514(c)(9)(E) of the…more

Internal Revenue Code (IRC), IRS, Proposed Regulation, Taxable Income, U.S. Treasury

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Trade & Manufacturing - News of Note - February 2017

Commerce Extends Steel Import Monitoring and Analysis System - On January 5, the Department of Commerce (Commerce) announced the extension of the Steel Import Monitoring and Analysis (SIMA) system until March 21, 2022. The…more

AGOA, Canada, Competition, Data Reporting, Duty Free

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HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of…more

21st Century Cures Act, FDA, Final Rules, HHS, Informed Consent

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Bill to Make Local Coverage Determinations More Transparent Introduced in House

On July 11, 2016, Reps. Lynn Jenkins (R-Kan.) and Ron Kind (D-Wis.) introduced the Local Coverage Determination Clarification Act (H.R. 5721), with the goal of modifying the LCD process performed by Medicare Administrative…more

Local Coverage Determination (LCD), MACs, Proposed Amendments

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Delaware Court of Chancery Dismisses Litigation Arising from Controller Buyout of Books-A-Million Under "MFW" Framework

On October 10, 2016, the Delaware Court of Chancery issued its decision in In re Books-A-Million, Inc. Stockholders Litigation. The decision, authored by Vice Chancellor J. Travis Laster, is important because it applies the…more

Acquisitions, Bad Faith, Board of Directors, Business Judgment Rule, Buyouts

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HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of…more

21st Century Cures Act, FDA, Final Rules, HHS, Informed Consent

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Trade & Manufacturing - News of Note - February 2017

Commerce Extends Steel Import Monitoring and Analysis System - On January 5, the Department of Commerce (Commerce) announced the extension of the Steel Import Monitoring and Analysis (SIMA) system until March 21, 2022. The…more

AGOA, Canada, Competition, Data Reporting, Duty Free

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Brexit Trade Audit: A Five-Step Guide to Help Determine the Way Forward

Companies doing business in the UK or from the UK should be looking to “future-proof” their operations following the UK’s recent vote to leave the European Union. A Brexit audit is one way of determining the possible impact of…more

Audits, EU, Goods or Services, Imports, Member State

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New Obama Administration Employment-based Visa Rule and Trump's Plan to Target Visa Abuse Create Uncertainty For Employers

President-elect Trump made enforcement of immigration laws a centerpiece of his campaign. On November 21, 2016, Mr. Trump stated that he will make investigation of abuses in “visa programs that undercut the American worker” a…more

DHS, DOL, Enforcement, H-1B, Presidential Elections

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The Viability of the “Primary Jurisdiction Doctrine” Defense and Other Ways to Stem the Tide of Food & Beverage Class Actions

As our readers are well aware, in the past decade, food and beverage manufacturers have faced an unrelenting onslaught of putative class actions challenging allegedly false or misleading labels. In the January 2016 issue, we…more

All Natural, Beverage Manufacturers, Chobani Inc, Class Action, Corporate Counsel

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Ninth Circuit Rules Lease Damages Cap Does Not Apply to Damages Independent of Termination

On December 29, 2016, the U.S. Court of Appeals for the Ninth Circuit (the “Court”) issued an opinion, holding that the statutory cap on a landlord’s damages claim in a bankruptcy case applies only to claims resulting directly…more

Appeals, Arbitration, Arbitration Awards, Attorney's Fees, Bankruptcy Court

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Outer Continental Shelf Leasing: BOEM Withdraws Controversial Sole Liability Orders

On February 17, 2017, the Bureau of Ocean Energy Management (“BOEM”), which manages oil and gas leasing in the Outer Continental Shelf, announced that it is withdrawing previously-issued orders to sole liability property owners…more

BOEM, Commercial Leases, Leases, Oil & Gas, Outer Continental Shelf

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Employers Are Advised to Proceed Cautiously Before Discussing Employee Recruitment and Compensation with Competitors as the DOJ and FTC Crack Down on Violations of Antitrust Laws

On October 20, 2016, the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) jointly issued Antitrust Guidance for Human Resource Professionals intended to alert those involved in hiring and…more

Antitrust Violations, Compensation, DOJ, FTC, Hiring & Firing

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HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of…more

21st Century Cures Act, FDA, Final Rules, HHS, Informed Consent

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NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises implications for software manufacturers and suppliers

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s…more

Automation Systems, Enforcement, Final Guidance, Motor Vehicles, NHTSA

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Seventh Republican Proposal to Replace the Affordable Care Act Is Introduced, “Patient Freedom Act of 2017”

On January 23, 2017, Senate Republicans Bill Cassidy, M.D. (LA), Susan Collins (ME), Shelley Moore Capito (WV) and Johnny Isakson (GA) introduced the legislative text for the Patient Freedom Act of 2017, a proposed replacement…more

Affordable Care Act, Health Insurance, Healthcare Reform, Medicaid, Medicare

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New OSHA Silica Rule Deadline Is Rapidly Approaching – Are You Ready?

While the Summer of 2018 may seem far away, companies should be preparing now to be ready to meet the significant new requirements of the U.S. Occupational Safety and Health Administration’s (“OSHA”) new rule for respirable…more

New Regulations, OSHA, Silica, Toxic Exposure, Workplace Hazards

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D.C. Circuit Rules CFPB’s Structure Unconstitutional

In a news-making decision with significant political implications, but probably limited near-term business or legal effects, the United States Court of Appeals for the District of Columbia Circuit held on Tuesday, October 11,…more

Administrative Proceedings, Article II, Banking Sector, CFPB, Constitutional Challenges

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Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in Spain…more

CMS, Cybersecurity, Energy Sector, EPA, EU

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Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in Spain…more

CMS, Cybersecurity, Energy Sector, EPA, EU

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CMS Reminds Providers to Identify Off-Campus Provider-Based Departments on Enrollment Forms

In connection with CMS’s implementation of Section 603 of the Bipartisan Budget Act of 2015 (BBA15), which directs CMS to no longer pay hospitals the full OPPS rate for services furnished in non-excepted off-campus…more

Bipartisan Budget Act, CMS, Health Care Providers, Hospitals, Off-Campus Departments

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SEC Cracks Down on Charitable Contributions under the FCPA - Best Practices In Light of Recent SEC Enforcement

For the first time, the Securities and Exchange Commission has brought an FCPA enforcement action premised entirely on a one-time charitable contribution. On September 20, 2016, the SEC announced a settled FCPA…more

Bribery, Charitable Donations, Charitable Organizations, China, Corruption

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FTC Announces Increased Hart-Scott-Rodino Thresholds - January 2017

On January 19, 2017, the Federal Trade Commission (FTC) announced revised jurisdictional thresholds for determining whether a proposed transaction must be reported to federal authorities under the Hart-Scott-Rodino (HSR)…more

Filing Fees, FTC, Hart-Scott-Rodino Act, Jurisdiction, Pre-Merger Filing Requirements

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Russia Supreme Court Rules On Phone Recordings

In a December 6, 2016 ruling [No. 35-KG16-18], the Supreme Court of Russia confirmed that secret recordings of telephone conversations can be admissible evidence in certain circumstances, changing a long-standing position…more

Admissible Evidence, Audio Recording, Privacy Rule, Russia, Supreme Court of the Russian Federation

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Energy Newsletter - October 2016

Negotiating an In-Project Construction Dispute - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the project schedule or costs,…more

Construction Contracts, Construction Industry, Construction Project, De Novo Standard of Review, Due Process

See All Updates »

FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding…more

Draft Guidance, FDA, First Amendment, Off-Label Promotion, Pharmaceutical Industry

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First Circuit Dismisses Claim That Fidelity Violated Its Fiduciary Duties By Retaining Float

In July, the Court of Appeals for the First Circuit rejected a claim that Fidelity breached its fiduciary duties by retaining “float” earned while Fidelity was handling 401(k) plan distributions. (Float is interest earned in…more

DOL, Fidelity Investments, Fiduciary Duty, Stock Float

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U.S. Apple Growers Win Rare Antidumping Case in Mexico

On June 7, the Mexican Ministry of the Economy (“Economía”) issued the final determination in its antidumping investigation on imports of apples from the United States, terminating such investigation on the basis of the absence…more

Anti-Dumping Duty, Imports, Mexico

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EU-U.S. Privacy Shield: Assessing The New Regime

Businesses have now had four months to get to grips with the new EU-U.S. Privacy Shield for transatlantic data transfers after it came into force in August 2016. As the New Year looms, what are the emerging trends we have seen…more

Data Privacy, Data Protection Authority, EU, EU-US Privacy Shield, European Commission

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LinkedIn Blocked in Russia: Privacy and Trade Law Aspect

The business networking platform LinkedIn is the first major international player to fall victim to the implementation of Russia’s “data localization” law, with effect from September 1, 2015, which requires all parties…more

Blocked Entities, Cross-Border Transactions, Data Localisation Law, GATS, Internet Service Providers (ISPs)

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SEC Files Action Against Company and its General Counsel for Loss Contingency Accrual and Disclosure Failures – What to Know

SEC’s Factual Allegations - On September 9, 2016, the Securities and Exchange Commission (“SEC”) filed a complaint against RPM International Inc. (“RPM”) and its General Counsel and Chief Compliance Officer, alleging the…more

Disclosure Requirements, DOJ, False Claims Act (FCA), Internal Investigations, Loss Contingencies

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Tokyo Dispute Resolution & Crisis Management Newsletter – December 2016

Major FCPA Enforcement Action - Including charges against the CEO and CFO for failing to prevent misconduct - In one of the largest FCPA settlements in history, hedge fund Och-Ziff Capital Management Group LLC…more

CEOs, Democratic Republic of Congo, Enforcement Actions, FCPA, Hedge Funds

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Meyers v. Nicolet Restaurant of De Pere, LLC: Seventh Circuit Rules Mere Failure to Truncate Credit Card Expiration Date Under FACTA Insufficient to Confer Article III Standing.

In Meyers v. Nicolet Restaurant of De Pere, LLC, an opinion issued on December 13, 2016, the United States Court of Appeals for the Seventh Circuit held that a proposed class action suit brought under the Fair and Accurate…more

Article III, Class Action, Debit and Credit Card Transactions, FACTA, Injury-in-Fact

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Loss of Foreign Fund Private Placement Exemptions in the UAE

In August 2016, the Emirates Securities and Commodities Authority (SCA), the federal securities regulator of the United Arab Emirates (UAE), adopted new investment funds regulations (the 2016 Fund Regulations), which repealed…more

Investment Funds, Private Placements, Reverse Solicitation, Securities and Commodities Authority (SCA), United Arab Emirates

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Employees Expecting Tax Refunds? So Are Your Hackers

With the beginning of the 2016 tax season, employers should be on high alert for the wave of W-2 spear phishing scams coming their way once again this year. Companies that fall victim to this type of scam likely will be faced…more

Data Protection, Hackers, IRS, Phishing Scams, Tax Refunds

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The Beginning of the National Bioengineered Food Disclosure Standard

In our last issue of the International Food Law Gazette, we reported on the changing legal landscape for the labeling of genetically engineered (GE) foods (more commonly referred to as genetically modified organisms, or GMO). In…more

Agricultural Sector, Bioengineering, Food Manufacturers, Genetically Engineered Seed, GMO

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President Trump Issues Memorandum On “Construction Of American Pipelines” -Prioritizes U.S.-Produced “Materials And Equipment”

On January 24, 2017, President Donald J. Trump signed a slate of executive orders and presidential memoranda focused on pipeline and other infrastructure projects. Along with memoranda that specifically concern the construction…more

Dakota Access Pipeline, EPA, Executive Orders, Keystone XL Pipeline, Oil & Gas

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Trade & Manufacturing - News of Note - February 2017

Commerce Extends Steel Import Monitoring and Analysis System - On January 5, the Department of Commerce (Commerce) announced the extension of the Steel Import Monitoring and Analysis (SIMA) system until March 21, 2022. The…more

AGOA, Canada, Competition, Data Reporting, Duty Free

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OIG Report Examines Minimum Loss Ratio Impact on South Carolina Medicaid Managed Care

OIG recently issued a report determining that South Carolina’s Medicaid Managed Care program would not have realized any savings if the state agency implemented a minimum Medical Loss Ratio (MLR) similar to the current Federal…more

Affordable Care Act, Health Care Providers, Healthcare Reform, MCOs, Medicaid

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TC Heartland v. Kraft: Awaiting a 2017 Supreme Court Decision with Potentially Significant Implications for Patent Litigation

Patent litigation continues to be concentrated in a small number of venues. Of the 4530 patent cases filed in 2016, for example, patentees chose the Eastern District of Texas more than one third of the time (1661 cases). In…more

Certiorari, Corporate Liability, Forum Shopping, Patent Infringement, Patent Litigation

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Second Circuit Reverses District Court’s Marblegate Decision; Narrows Protections Provided to Bondholders Under Section 316(b) of Trust Indenture Act

The Trust Indenture Act of 1939 (the “TIA”) codifies a select set of requirements and prohibitions intended to protect perceived “sacred rights” of holders of public bond instruments. When the U.S. District Court for the…more

Bonds, Creditors, Financial Institutions, Section 316(b), Secured Debt

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The Common Law Touch - The status of English law for international business post-Brexit

The UK referendum result in June 2016, which saw the majority of the electorate vote to leave the European Union (EU), has presented many questions about the future legal implications of a Brexit. While individual legislative…more

English Common Law, EU, Member State, Referendums, UK

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China Promulgates New Cybersecurity Law

On Monday, November 7, 2016, the Standing Committee of the National People’s Congress of China promulgated a new cybersecurity law, providing the Chinese government with sweeping authority to regulate and monitor internet…more

China, Cyber Attacks, Cybersecurity, Data Privacy, Data Protection

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Eleventh Circuit Confirms that Issuers are not Required to Disclose Retention of Outside Promotional Firms

On December 15, 2016, the United States Court of Appeals for the Eleventh Circuit affirmed the dismissal of a securities class action against Galectin Therapeutics Inc., a Georgia-based biotechnology company. The suit alleged…more

Disclosure Requirements, Financial Markets, Pharmaceutical Industry, Public Offerings, Publicly-Traded Companies

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Saudi Arabia unveils new US$50 billion water desalination programme - The Kingdom to offer privatisations as well as new water desalination project contracts

The Ministry of Environment, Water and Agriculture of Saudi Arabia has announced a new water desalination programme involving private sector participation worth over an estimated US$50 billion. The programme will be split…more

Desalination, Private Sector, Public Private Partnerships (P3s), Saudi Arabia, Water

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HRSA Issues Final Rule on Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties

Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs - On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule…more

Civil Monetary Penalty, Drug Pricing, HRSA, Pharmaceutical Industry, Section 340B

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CMS’s Interim Final Rule to Permit “Stacking” of Reclassifications Puts Pressure on Urban Hospitals to Evaluate Advantages of Geographic Reclassification to “Rural” Status for Wage Index Purposes in Advance of September 1 Deadline

Hospitals may seek redesignation to a neighboring core-based statistical area for wage index purposes under the rules that set forth the geographic reclassification process. See 42 C.F.R. § 412.230 et seq. Those rules require…more

Anti-Stacking Provisions, CMS, Hospitals, Interim Rule, Reclassification Rules

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EU-U.S. Privacy Shield: Assessing The New Regime

Businesses have now had four months to get to grips with the new EU-U.S. Privacy Shield for transatlantic data transfers after it came into force in August 2016. As the New Year looms, what are the emerging trends we have seen…more

Data Privacy, Data Protection Authority, EU, EU-US Privacy Shield, European Commission

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Building a Favorable Project Record During Construction Disputes

The value and importance of the written record in a dispute arising from a major construction project cannot be overstated. Even when project personnel are available to provide first-hand accounts—which often is challenging…more

Construction Contracts, Construction Disputes, Construction Industry, Construction Project, General Contractors

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HRSA Withdraws 340B Program “Mega Guidance” from OMB Review

On January 30, 2017, the Health Resources and Services Administration (HRSA) withdrew its 340B Program Omnibus Guidelines (Guidelines) from regulatory review by the Office of Management and Budget (OMB). HRSA published the…more

HHS, HRSA, Omnibus Guidance, Proposed Rules, Section 340B

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Eleventh Circuit Confirms that Issuers are not Required to Disclose Retention of Outside Promotional Firms

On December 15, 2016, the United States Court of Appeals for the Eleventh Circuit affirmed the dismissal of a securities class action against Galectin Therapeutics Inc., a Georgia-based biotechnology company. The suit alleged…more

Disclosure Requirements, Financial Markets, Pharmaceutical Industry, Public Offerings, Publicly-Traded Companies

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IRS and Treasury Issue Proposed Regulations Easing Some of the Burden of the Fractions Rule

Executive Summary On November 22, the Internal Revenue Service (“IRS”) and Treasury Department issued proposed regulations (REG-136978-12, the “Proposed Regulations”) under the “fractions rule” of Section 514(c)(9)(E) of the…more

Internal Revenue Code (IRC), IRS, Proposed Regulation, Taxable Income, U.S. Treasury

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Proxy Advisory Firms Issue 2017 Voting Guidelines

Proxy advisory firms Institutional Shareholder Services (ISS) and Glass, Lewis & Co. (Glass Lewis) recently issued updated proxy voting guidelines for the upcoming 2017 proxy season. Notable updates were issued by one or both…more

Glass Lewis, IPO, ISS, Overboarding, Proxy Advisors

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Brexit: UK Government Publishes EU Exit Plan - Official policy document outlines agenda on laws, workers’ rights, trade and free movement of people

The UK Government published its long-awaited official policy document on Brexit – the UK’s withdrawal from the European Union (EU) – on 2 February, 2017, which outlined many of its goals for the Brexit process. The…more

Corporate Counsel, EU, EU Single Market, Free Movement, Free Trade Agreements

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Brexit: UK Government Publishes EU Exit Plan - Official policy document outlines agenda on laws, workers’ rights, trade and free movement of people

The UK Government published its long-awaited official policy document on Brexit – the UK’s withdrawal from the European Union (EU) – on 2 February, 2017, which outlined many of its goals for the Brexit process. The…more

Corporate Counsel, EU, EU Single Market, Free Movement, Free Trade Agreements

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Recently Introduced Legislation Designed To Secure Voting Systems

On September 21, 2016, Representative Hank Johnson (R-GA) introduced two bills in the U.S. House of Representatives that aim to protect U.S. voting systems from hackers. These two pieces of legislation—the “Election…more

DHS, Federal Elections, Hackers, Infrastructure, Voter Registration

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Long Anticipated Bankruptcy Law Goes Into Effect

On 20 September 2016, the new Bankruptcy Law (the Law) for the UAE was enacted. The Law was gazetted on 29 September 2016 and comes into effect on 31 December 2016. The Law will be supplemented by procedural regulations to be…more

Creditors, Debtors, Insolvency, Liquidation, UAE

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AshleyMadison.com Operators Settle With FTC And States For $1.66 Million

On December 14, 2016, the Federal Trade Commission (the “FTC”) announced that ruby Corp., ruby Life Inc., and ADL Media Inc. (the “Defendants”) agreed to a settlement with the FTC, 13 states, and the District of Columbia. The…more

Ashley Madison, Data Breach, FTC, Personally Identifiable Information, Websites

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Proxy Advisory Firms Issue 2017 Voting Guidelines

Proxy advisory firms Institutional Shareholder Services (ISS) and Glass, Lewis & Co. (Glass Lewis) recently issued updated proxy voting guidelines for the upcoming 2017 proxy season. Notable updates were issued by one or both…more

Glass Lewis, IPO, ISS, Overboarding, Proxy Advisors

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House Legislation Purports To Require Warrants For All Email

On February 6, 2017, the U.S. House of Representatives unanimously passed the Email Privacy Act (the “Act”), co-sponsored by Representatives Kevin Yoder (R-KS) and Jared Polis (D-CO), which would require law enforcement to…more

Data Privacy, Email, Email Privacy Act, Fourth Amendment, Stored Communications Act

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FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding…more

Draft Guidance, FDA, First Amendment, Off-Label Promotion, Pharmaceutical Industry

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Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in Spain…more

CMS, Cybersecurity, Energy Sector, EPA, EU

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Delaware Court of Chancery Dismisses Litigation Arising from Controller Buyout of Books-A-Million Under "MFW" Framework

On October 10, 2016, the Delaware Court of Chancery issued its decision in In re Books-A-Million, Inc. Stockholders Litigation. The decision, authored by Vice Chancellor J. Travis Laster, is important because it applies the…more

Acquisitions, Bad Faith, Board of Directors, Business Judgment Rule, Buyouts

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Energy Newsletter - October 2016

Negotiating an In-Project Construction Dispute - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the project schedule or costs,…more

Construction Contracts, Construction Industry, Construction Project, De Novo Standard of Review, Due Process

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Global Investigations Review Conference Highlights the Future of Anti-Corruption Enforcement Recapping GIR Live DC

On February 16, 2017, Global Investigations Review (“GIR”) held its second annual GIR Live DC in Washington, D.C. With an emphasis on global anticorruption enforcement, the event featured a variety of experts in complex,…more

Anti-Bribery, Anti-Corruption, Confidential Information, DOJ, FCPA

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FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed Tests…more

CLIA, CMS, Draft Guidance, FDA, Laboratory Developed Tests

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Energy Newsletter - September 2016

Implementing Islamic Financing for Renewable Energy Projects - The Middle East and North Africa (MENA) region has recently seen a surge of interest in developing renewable energy, in particular solar energy projects. Led by…more

Acquisitions, Bankruptcy Code, BOEM, Coal Industry, Covenants that Run With the Land

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EU-U.S. Privacy Shield: Assessing The New Regime

Businesses have now had four months to get to grips with the new EU-U.S. Privacy Shield for transatlantic data transfers after it came into force in August 2016. As the New Year looms, what are the emerging trends we have seen…more

Data Privacy, Data Protection Authority, EU, EU-US Privacy Shield, European Commission

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HRSA Withdraws 340B Program “Mega Guidance” from OMB Review

On January 30, 2017, the Health Resources and Services Administration (HRSA) withdrew its 340B Program Omnibus Guidelines (Guidelines) from regulatory review by the Office of Management and Budget (OMB). HRSA published the…more

HHS, HRSA, Omnibus Guidance, Proposed Rules, Section 340B

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Washington Insight - September 2016

House Financial Services Committee Votes To Repeal And Replace Dodd-Frank - On September 13th, the House Financial Services Committee approved the Financial CHOICE Act of 2016 to repeal and replace key parts of the 2010…more

Broker-Dealer, CFPB, Class Action, Commercial Real Estate Market, Cyber Threats

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CMS Clarifies the Application Processes for the Mid-Build Exception under the 21st Century Cures Act and for Relocation Exception Requests under the CY 2017 OPPS Final Rule

CMS has issued guidance documents addressing how hospitals can (1) qualify an off-campus provider-based department (PBD) for the “mid-build” exception set forth in the 21st Century Cures Act and (2) request from their CMS…more

21st Century Cures Act, Bipartisan Budget Act, CMS, Hospitals, Off-Campus Departments

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Energy Newsletter - October 2016

Negotiating an In-Project Construction Dispute - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the project schedule or costs,…more

Construction Contracts, Construction Industry, Construction Project, De Novo Standard of Review, Due Process

See All Updates »

Tax Reform Considerations for REITs

Various components of the tax reform proposals that have been put forth by the Congress as well as the President could have significant impacts on REITs. In 2016, the Republican leadership and Republicans on the House Committee…more

Corporate Taxes, Interest Rates, Like Kind Exchanges, REIT, Tax Reform

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Second Circuit Reverses District Court’s Marblegate Decision; Narrows Protections Provided to Bondholders Under Section 316(b) of Trust Indenture Act

The Trust Indenture Act of 1939 (the “TIA”) codifies a select set of requirements and prohibitions intended to protect perceived “sacred rights” of holders of public bond instruments. When the U.S. District Court for the…more

Bonds, Creditors, Financial Institutions, Section 316(b), Secured Debt

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FTC Testifies Before Senate Commerce Committee About Data Security Approach

On Tuesday, September 27, 2016, the three active commissioners at the Federal Trade Commission (“FTC” or the “Commission”) testified before the U.S. Senate Committee on Commerce, Science, and Transportation regarding the…more

Data Security, FTC, FTC Act, Popular, Section 5

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FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding…more

Draft Guidance, FDA, First Amendment, Off-Label Promotion, Pharmaceutical Industry

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New Obama Administration Employment-based Visa Rule and Trump's Plan to Target Visa Abuse Create Uncertainty For Employers

President-elect Trump made enforcement of immigration laws a centerpiece of his campaign. On November 21, 2016, Mr. Trump stated that he will make investigation of abuses in “visa programs that undercut the American worker” a…more

DHS, DOL, Enforcement, H-1B, Presidential Elections

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FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed Tests…more

CLIA, CMS, Draft Guidance, FDA, Laboratory Developed Tests

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FinCEN Issues Advisory on Jurisdictions with AML/CFT Deficiencies

The Financial Crimes Enforcement Network (“FinCEN”), an agency within the U.S. Treasury Department, has put forth an Advisory on the FATFIdentified Jurisdictions with AML/CFT (Anti-Money Laundering/Combating the Financing of…more

AML/CFT, EDD, FATF, Financial Institutions, FinCEN

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Proposed Rule Would Mandate Vehicle-To-Vehicle Communication On Light Vehicles

The U.S. Department of Transportation (“DOT”) issued a proposed rule on Tuesday, December 13, 2016, that would advance the deployment of connected vehicle technologies throughout the U.S. light vehicle fleet. The aim of the new…more

Advanced Notice of Proposed Rulemaking (ANPRM), Department of Transportation (DOT), Motor Vehicles, NHTSA, Proposed Rules

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HRSA Issues Final Rule on Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties

Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs - On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule…more

Civil Monetary Penalty, Drug Pricing, HRSA, Pharmaceutical Industry, Section 340B

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Digesting the €13 Billion Apple-EU Tax Ruling

King & Spalding experts assess what international businesses need to be aware of following the EC's ruling on State Aid in the Apple case - Partners in King & Spalding’s tax department have shared their perspectives and…more

Apple, Corporate Taxes, EU, European Commission, Ireland

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FCC Releases Cybersecurity Risk Reduction White Paper

On January 18, 2017, during the final days of the Obama Administration, the Federal Communications Commission (“FCC”) released a white paper (the “FCC Paper”) on cybersecurity risk mitigation in communications networks. The FCC…more

Cybersecurity, Data Protection, Data Security, FCC, Risk Mitigation

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Trade & Manufacturing - News of Note - January 2017

Customs and Border Protection Issues Update On Enforcement Of Trade Orders - U.S. Customs and Border Protection (CBP) released its AD/CVD Update for June/July 2016. As explained in the January 2015 and the August 2016…more

Anti-Dumping Duty, Canada, China, Countervailing Duties, Customs and Border Protection

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Government Accountability Office Issues Report On Department Of Homeland Security’s National Cybersecurity And Communications Integration Center

On February 1, 2017, the United States Government Accountability Office (“GAO”) published a report assessing the performance and effectiveness of the National Cybersecurity and Communications Integration Center (“NCCIC”) of the…more

Cybersecurity, Cybersecurity Act of 2015, DHS, GAO, NCCIC

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CMS and OIG Propose First Major Medicaid Fraud Control Program Changes Since 1978

On September 20, 2016, CMS and the OIG jointly published a proposed rule, available here, to amend the largely unchanged 1978 regulation governing State Medicaid Fraud Control Units (MFCUs). Since the initial issuance of the…more

CMS, Fraud, Medicaid, OIG, Proposed Rules

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Meyers v. Nicolet Restaurant of De Pere, LLC: Seventh Circuit Rules Mere Failure to Truncate Credit Card Expiration Date Under FACTA Insufficient to Confer Article III Standing.

In Meyers v. Nicolet Restaurant of De Pere, LLC, an opinion issued on December 13, 2016, the United States Court of Appeals for the Seventh Circuit held that a proposed class action suit brought under the Fair and Accurate…more

Article III, Class Action, Debit and Credit Card Transactions, FACTA, Injury-in-Fact

See All Updates »

Proxy Advisory Firms Issue 2017 Voting Guidelines

Proxy advisory firms Institutional Shareholder Services (ISS) and Glass, Lewis & Co. (Glass Lewis) recently issued updated proxy voting guidelines for the upcoming 2017 proxy season. Notable updates were issued by one or both…more

Glass Lewis, IPO, ISS, Overboarding, Proxy Advisors

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Eleventh Circuit Confirms that Issuers are not Required to Disclose Retention of Outside Promotional Firms

On December 15, 2016, the United States Court of Appeals for the Eleventh Circuit affirmed the dismissal of a securities class action against Galectin Therapeutics Inc., a Georgia-based biotechnology company. The suit alleged…more

Disclosure Requirements, Financial Markets, Pharmaceutical Industry, Public Offerings, Publicly-Traded Companies

See All Updates »

Commerce Establishes Advisory Council on Trade Enforcement and Compliance

On January 4, the Department of Commerce (Commerce) announced the establishment of the Advisory Council on Trade Enforcement and Compliance (ACTEC). The ACTEC is a government-business forum that will seek “stakeholder input…more

Obama Administration, Trade Policy, U.S. Commerce Department

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Saudi Arabia and the Gulf Cooperation Council: Infrastructure Delivery Including Under a Public Private Partnership Model: Top 10 Tendering Tips

The sovereign funding gap caused by a low oil price environment, coupled with a global period of economic uncertainty, are two drivers leading governments and state owned enterprises (SOEs) throughout the Middle East and North…more

Competitive Bidding, Construction Project, Infrastructure, Oil & Gas, Oil Prices

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A Quick Snapshot Of President-Elect Trump's Foreign Policy Agenda

The big guessing game now in the wake of the election is, to what degree should we take Mr. Trump’s election campaign rhetoric literally? This question applies across the board, but in foreign affairs the mystery may be deeper…more

Foreign Policy, Presidential Elections, Trump Administration

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Washington Insight - September 2016

House Financial Services Committee Votes To Repeal And Replace Dodd-Frank - On September 13th, the House Financial Services Committee approved the Financial CHOICE Act of 2016 to repeal and replace key parts of the 2010…more

Broker-Dealer, CFPB, Class Action, Commercial Real Estate Market, Cyber Threats

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Update – Sweden’s Request to Ban American Lobster in the EU Risks Violating the Rules of the WTO

In July 2016, we reported that the Swedish Government had requested that the European Union impose a ban on imports of U.S./Canadian live lobster (Homarus americanus). Sweden argues that Homarus americanus should be designated…more

EU, Food Borne Bacteria, Imports, Scientific Evidence, Sweden

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DOJ Wins Again, Blocks Anthem/Cigna Merger

On February 8, 2017, the United States District Court for the District of Columbia granted the Department of Justice, Antitrust Division’s (the “DOJ”) request for an injunction blocking Anthem’s proposed $54 billion acquisition…more

Acquisitions, CIGNA, DOJ, FTC, Health Insurance

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Forewarned is Forearmed—Hosting Events at the Political Conventions

Organizations that plan to provide entertainment to Members and staff of the United States House of Representatives and Senate at the political party conventions should remind themselves of the unique rules that apply to…more

Campaign Contributions, Lobbying, Lobbying Disclosure Act, Lobbyists

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Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in Spain…more

CMS, Cybersecurity, Energy Sector, EPA, EU

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Briseno v. ConAgra Foods, Inc.: Ninth Circuit Rules That There Need Not Be An Administratively Feasible Way To Identify Class Members In GMO Natural Case

In Briseno v. ConAgra Foods, Inc., an opinion issued on January 3, 2017, the United States Court of Appeals for the Ninth Circuit held that Federal Rule of Civil Procedure 23 does not require plaintiffs challenging the labeling…more

All Natural, Class Action, Federal Rules of Civil Procedure, Food Labeling, GMO

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Proxy Advisory Firms Issue 2017 Voting Guidelines

Proxy advisory firms Institutional Shareholder Services (ISS) and Glass, Lewis & Co. (Glass Lewis) recently issued updated proxy voting guidelines for the upcoming 2017 proxy season. Notable updates were issued by one or both…more

Glass Lewis, IPO, ISS, Overboarding, Proxy Advisors

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DOJ Settles with Nursing Home for Allegations of Worthless Services

On February 1, 2017, an Iowa nursing facility and residential care facility operator entered into a settlement agreement (the Agreement) with DOJ and the State of Iowa for alleged violations of the False Claims Act for the…more

DOJ, False Claims Act (FCA), Medicaid, Nursing Homes, Settlement Agreements

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Washington Insight - September 2016

House Financial Services Committee Votes To Repeal And Replace Dodd-Frank - On September 13th, the House Financial Services Committee approved the Financial CHOICE Act of 2016 to repeal and replace key parts of the 2010…more

Broker-Dealer, CFPB, Class Action, Commercial Real Estate Market, Cyber Threats

See All Updates »

TCPA Lawsuit Surges Ahead, Even Though Plaintiff Deleted Text Messages

Pizza Hut and several franchise owners are currently defending a class action lawsuit in the U.S. District Court for Southern District of Florida based on claims that their 2011 promotional text-message campaign violated the…more

ATDS, Class Action, FCC, Marketing, Pizza Hut

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Compensation and Benefits Insights – September 2016 #2

Hardly Water Under the Bridge: NLRB, SEC, OSHA Mount Offensive Against Confidentiality Agreements - A recent New York Times story shed light on complaints by an employee of Bridgewater Associates, a $154 billion hedge fund…more

Confidential Information, Deadlines, DOL, ERISA, Health and Welfare Plans

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CMS Releases Final Rule Updating Home Health Agency Conditions of Participation­

CMS issued a final rule, which was published in the Federal Register on January 13, 2017, intended to modernize the home health agency Conditions of Participation (CoPs). The rule, which goes into effect on July 13, 2017, seeks…more

CMS, Final Rules, Home Health Agencies, Home Health Care, OASIS

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Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in Spain…more

CMS, Cybersecurity, Energy Sector, EPA, EU

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Establishment of the Parallel Market of the Saudi Stock Exchange

Background - On 21 December 2016, the Capital Market Authority of Saudi Arabia (the CMA) approved the Parallel Market Listing Rules (the Rules), thereby establishing the Parallel Market, an alternative market to the Main…more

Capital Markets Authority, Financial Adviser, Foreign Financial Institutions (FFI), Saudi Arabia, Saudi Stock Exchange

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Employees Expecting Tax Refunds? So Are Your Hackers

With the beginning of the 2016 tax season, employers should be on high alert for the wave of W-2 spear phishing scams coming their way once again this year. Companies that fall victim to this type of scam likely will be faced…more

Data Protection, Hackers, IRS, Phishing Scams, Tax Refunds

See All Updates »

Second Circuit Clarifies Law on Enforcement of Foreign Arbitral Awards under the New York Convention

On January 18, 2017, the United States Court of Appeals for the Second Circuit (Second Circuit) issued its decision in CBF Indústría de Gusa S/A v. AMCI Holdings, Inc., a case considering important questions on the application…more

Arbitration, Arbitration Awards, Federal Arbitration Act, International Arbitration, New York Convention

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MedPAC Votes on Medicare Payment Rate Sufficiency

On January 12, 2017, Medicare Payment Advisory Commission (MedPAC) members unanimously voted to maintain Medicare’s existing updates (i.e., maintain the increases Congress and the HHS Secretary have already established) to…more

Ambulatory Surgery Centers, HHS, Hospice, Medicare, MedPAC

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Implementing A Competitive Natural Gas Market In Mexico - CENAGAS to hold its first open season

Centro Nacional de Control de Gas Natural (CENAGAS) has received authorization from the Comisión Reguladora de Energía (CRE) to conduct its first open season for the assignment of available capacity on a firm basis in the…more

Competitive Bidding, Deadlines, Electricity, Energy Sector, Foreign Investment

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Tax Reform Considerations for REITs

Various components of the tax reform proposals that have been put forth by the Congress as well as the President could have significant impacts on REITs. In 2016, the Republican leadership and Republicans on the House Committee…more

Corporate Taxes, Interest Rates, Like Kind Exchanges, REIT, Tax Reform

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European Chemical Agency Publishes Call for Evidence on the Use of Formaldehyde Releasers

On July 6, 2016, the European Chemicals Agency (ECHA) issued a call for evidence from relevant stakeholders to gather information on the uses of formaldehyde releasers. ECHA intends to issue a report to inform the Commission’s…more

Chemicals, ECHA, EU, REACH, Request For Information

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President Trump Issues Memorandum On “Construction Of American Pipelines” -Prioritizes U.S.-Produced “Materials And Equipment”

On January 24, 2017, President Donald J. Trump signed a slate of executive orders and presidential memoranda focused on pipeline and other infrastructure projects. Along with memoranda that specifically concern the construction…more

Dakota Access Pipeline, EPA, Executive Orders, Keystone XL Pipeline, Oil & Gas

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Digesting the €13 Billion Apple-EU Tax Ruling

King & Spalding experts assess what international businesses need to be aware of following the EC's ruling on State Aid in the Apple case - Partners in King & Spalding’s tax department have shared their perspectives and…more

Apple, Corporate Taxes, EU, European Commission, Ireland

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FinCEN Issues Advisory on Jurisdictions with AML/CFT Deficiencies

The Financial Crimes Enforcement Network (“FinCEN”), an agency within the U.S. Treasury Department, has put forth an Advisory on the FATFIdentified Jurisdictions with AML/CFT (Anti-Money Laundering/Combating the Financing of…more

AML/CFT, EDD, FATF, Financial Institutions, FinCEN

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Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in Spain…more

CMS, Cybersecurity, Energy Sector, EPA, EU

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Energy Newsletter - October 2016

Negotiating an In-Project Construction Dispute - Many thorny and competing interests are implicated when an ongoing major construction project experiences an unanticipated event that impacts the project schedule or costs,…more

Construction Contracts, Construction Industry, Construction Project, De Novo Standard of Review, Due Process

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Tax Reform Considerations for REITs

Various components of the tax reform proposals that have been put forth by the Congress as well as the President could have significant impacts on REITs. In 2016, the Republican leadership and Republicans on the House Committee…more

Corporate Taxes, Interest Rates, Like Kind Exchanges, REIT, Tax Reform

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European Union Member States Vote In Support Of The Privacy Shield

On July 8, 2016, the European Union (“EU”) member states voted in support of the Privacy Shield through the Article 31 Committee, which is composed of representatives of the 28 member states. The Privacy Shield would replace…more

EU, EU Data Protection Laws, EU-US Privacy Shield, European Commission, International Data Transfers

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President Trump’s “Two Simple Rules: Buy American And Hire American”

The first days of the Presidency of Donald J. Trump confirm the new Administration’s focus on international trade. Several trade-related developments initiated by the White House include the following..…more

International Trade, NAFTA, Trade Policy, Trade Relations, Trans-Pacific Partnership

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D.C. Circuit Rules CFPB’s Structure Unconstitutional

In a news-making decision with significant political implications, but probably limited near-term business or legal effects, the United States Court of Appeals for the District of Columbia Circuit held on Tuesday, October 11,…more

Administrative Proceedings, Article II, Banking Sector, CFPB, Constitutional Challenges

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Tax Reform Considerations for REITs

Various components of the tax reform proposals that have been put forth by the Congress as well as the President could have significant impacts on REITs. In 2016, the Republican leadership and Republicans on the House Committee…more

Corporate Taxes, Interest Rates, Like Kind Exchanges, REIT, Tax Reform

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Supreme Court Rules that Citizenship of a Real Estate Investment Entity is Based on Citizenship of its Members, Which Includes Shareholders

On March 7, 2016, the U.S. Supreme Court (the “Supreme Court”) ruled that the citizenship of a Real Estate Investment Entity (“REIT”), for purposes of federal diversity jurisdiction, is based on the citizenship of its members,…more

Americold Realty Trust v Conagra Foods, Citizenship, Diversity Jurisdiction, Members, REIT

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Meaning of “Commencement of Drilling”: Summary of Vitol E & P Limited v Africa Oil and Gas Corporation [2016] EWHC 1677 (Comm)

Introduction - In a dispute arising in connection with a sale and purchase agreement for an interest under a Production Sharing Contract in the Congo, an English court (the Queen's Bench Division of the High Court of…more

Acquisitions, Africa, Contract Disputes, Deferred Consideration, Democratic Republic of Congo

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HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of…more

21st Century Cures Act, FDA, Final Rules, HHS, Informed Consent

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New OSHA Silica Rule Deadline Is Rapidly Approaching – Are You Ready?

While the Summer of 2018 may seem far away, companies should be preparing now to be ready to meet the significant new requirements of the U.S. Occupational Safety and Health Administration’s (“OSHA”) new rule for respirable…more

New Regulations, OSHA, Silica, Toxic Exposure, Workplace Hazards

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Presidential “Notice” Triggers New Iran Sanctions Designations

On February 3, 2017, the Office of Foreign Assets Control (“OFAC”) of the U.S. Department of the Treasury added twenty-five individuals and entities to its Specially Designated Nationals (“SDN”) List. According to the White…more

Iran Sanctions, Joint Comprehensive Plan of Action (JCPOA), OFAC, SDN List, Trump Administration

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Update – Sweden’s Request to Ban American Lobster in the EU Risks Violating the Rules of the WTO

In July 2016, we reported that the Swedish Government had requested that the European Union impose a ban on imports of U.S./Canadian live lobster (Homarus americanus). Sweden argues that Homarus americanus should be designated…more

EU, Food Borne Bacteria, Imports, Scientific Evidence, Sweden

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HHS Report Acknowledges Complications of Fraud and Abuse Statutes on Value-Based Arrangements

HHS posted a report to Congress on its website in August 2016 that responds to the requirements in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to offer legislative and regulatory suggestions regarding the…more

American Hospital Association, Fraud and Abuse, HHS, Medicare Access and CHIP Reauthorization (MACRA), OIG

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LNG Disputes on the Rise

Although some in the LNG industry are generally aware of price review disputes (mostly in Europe) that occurred during the last decade, the growing overall trend globally in LNG disputes (especially via international…more

Buyers, Infrastructure, International Arbitration, Liquid Natural Gas, Oil & Gas

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DOL Finalizes ACA Retaliation Protections for Employees

Final regulations were issued by the Department of Labor (“DOL”) on October 12, 2016 (“Final Rules”) governing employee retaliation protections under the Patient Protection and Affordable Care Act of 2010, as amended (the…more

Affordable Care Act, Anti-Retaliation Provisions, Applicable Large Employers (ALE), DOL, Final Rules

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CMS Issues Final Rule for New Cardiac, Orthopedic Bundled Payment Models

On December 20, 2016, CMS issued its final rule implementing three new Medicare Parts A and B episode payment models for patients admitted for treatment for heart attack, bypass surgery, or hip/femur fracture under its Section…more

CMS, HHS, Hospitals, Medicare, Payment Methods

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Ninth Circuit Rules Lease Damages Cap Does Not Apply to Damages Independent of Termination

On December 29, 2016, the U.S. Court of Appeals for the Ninth Circuit (the “Court”) issued an opinion, holding that the statutory cap on a landlord’s damages claim in a bankruptcy case applies only to claims resulting directly…more

Appeals, Arbitration, Arbitration Awards, Attorney's Fees, Bankruptcy Court

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Saudi Arabia Takes First Steps to Privatise US$50 Billion of Water Sector Assets

Ali Al-Hazmi Appointed Governor of Saline Water Conversion Corporation as Kingdom Proceeds with Vision 2030 Privatisation Initiative - The Kingdom of Saudi Arabia last week announced that Ali Al-Hazmi is replacing…more

Saudi Arabia, Water Conservation

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CMS Releases List of Potential Quality and Efficiency Reporting Measures

On November 22, 2016, CMS published its annual list of quality and efficiency measures under consideration for adoption through the rulemaking process. CMS is considering approximately 100 measures for incorporation into…more

CMS, Reporting Requirements

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New Bipartisan Bill Calls For Study Of Cybersecurity Standards For Motor Vehicles

On Tuesday, January 24, 2017, U.S. Representatives Ted Lieu (D-CA) and Joe Wilson (R-SC) introduced the Security and Privacy in Your Car Study Act of 2017. The bill, H.R. 701, directs the National Highway Traffic Safety…more

Cybersecurity, Motor Vehicles, NHTSA, Technology, Technology Sector

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HHS Announces Final Rule on Medicare Benefit Claim Appeals Process

On January 17, 2017, HHS published its final rule addressing modifications to the Medicare benefit claim appeals process. The final rule seeks to reduce the significant backlog of pending Medicare appeals and streamline the…more

Appeals, CMS, HHS, Medicare, OMHA

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United States Challenges China’s Aluminum Subsidies at the WTO

On January 12, the United States filed a request for consultations at the World Trade Organization (WTO) regarding the substantial subsidies that the Chinese government has been pouring into its primary aluminum industry from…more

Aluminum Sales, China, Consultation, Subsidiaries, United Steelworkers

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FTC and States Reach $100 Million Antitrust Settlement with Mallinckrodt

On January 18, 2017, the Federal Trade Commission (“FTC”) announced that it reached a $100 million settlement with pharmaceutical company Questcor Pharmaartinceuticals, Inc. and its Irish parent company, Mallinckrodt plc. The…more

Antitrust Violations, FTC, Monopolization, Pharmaceutical Industry, Settlement

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Blue Shield Of California Avoids TCPA Class Action Over Pre-Recorded Call

On January 13, 2017, the United States District Court for the Central District of California granted Blue Shield of California’s motion for summary judgment in a case on whether the insurer violated the Telephone Consumer…more

ATDS, Blue Shield, Corporate Counsel, FCC, Prior Express Consent

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FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed Tests…more

CLIA, CMS, Draft Guidance, FDA, Laboratory Developed Tests

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Contact

1180 Peachtree Street NE
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