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FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing…more

Drug Wholesaling, DSCSA, FDA, Pharmaceutical, Pharmaceutical Manufacturers

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California Enacts Comprehensive Groundwater Management Legislation

On September 16, 2014, California Governor Jerry Brown signed into law a historic package of three bills—Senate Bill 1168, Senate Bill 1319 and Assembly Bill 1739—instituting comprehensive groundwater management in California…more

Drought, Environmental Policies, Groundwater, Water

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Taking On The Internet For Your Client's Reputation

My cell phone rings at 6:30 on a Friday evening. It's the CEO of a client company and she is panicked. Hysterical. It turns out she was doing some "old-fashioned" investigating by performing Google searches on herself and the…more

DMCA, Reputation Management, Terms of Use, User-Generated Content, Websites

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Renewed Focus on European Cookie Laws

We have reported previously in our Duane Morris Alerts about the progress with new cookie laws across Europe. The laws were introduced following a European Union Directive [the E-Privacy Directive (2009/136/EC)] at the end of…more

Cookies, Cybersecurity, Data Protection, EU, Internet

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DOJ and the SEC Issue New FCPA Guidance

On November 14, 2012, the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) published "A Resource Guide to the U.S. Foreign Corrupt Practices Act." Through the Guide, DOJ and the SEC provide the most…more

Compliance, DOJ, FCPA, FCPA Resource Guide, SEC

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New Jersey Prepayment Law Does Not Apply to Individual Guarantors of a Commercial Loan

The New Jersey Superior Court, in Lopresti v. Wells Fargo Bank, N.A., determined that the New Jersey Prepayment Law, N.J.S.A. § 46:10B-1, does not apply to individual guarantors who had guaranteed a commercial loan. There, the…more

Commercial Loans, Guarantors, Mortgages, Prepayment Penalties

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5 Attributes of a Successful Non-Compete Agreement

Given the rising use of non-competes in all manner of businesses, we asked JD Supra contributors to tell us what's required in a successful agreement between employer and employee. Here is what we heard back…more

Employment Contract, Hiring & Firing, Legal Perspectives, Non-Compete Agreements, Popular

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FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing…more

Drug Wholesaling, DSCSA, FDA, Pharmaceutical, Pharmaceutical Manufacturers

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Guide to Publicly Offered Private Placements Under New Rule 506(c)

Background: A company that needs capital to expand its business or fund its operations often chooses to sell stock or other securities to investors in order to meet its funding requirements. All offerings of stock or…more

Bad Actors, Dodd-Frank, Filing Requirements, Investors, JOBS Act

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Tax Deadlines Still in Effect, Despite Government Shutdown

The U.S. federal government shutdown does not alleviate the October 15 filing deadline or other upcoming filing and payment requirements. The current state of the government shutdown has many taxpayers questioning whether…more

Filing Deadlines, Government Shutdown, IRS, Tax Liens, Tax Refunds

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Georgia Supreme Court Affirms Business Judgment Rule

The Georgia Supreme Court has, for the first time, affirmed the existence of the business judgment rule in Georgia common law. More specifically, however, the state Supreme Court held that the business judgment rule does not…more

Board of Directors, Business Judgment Rule, Corporate Officers, Directors, Due Diligence

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Government of India Discloses Names of Overseas Bank Account Holders: Risk and Ramifications Analysis

The Government of India (GOI) on 27 October 2014 made a disclosure to the Supreme Court of India containing the names of three prominent individuals who had opened overseas bank accounts allegedly with proceeds tainted with..…more

Foreign Bank Accounts, India, Risk Assessment, Risk Management, Third-Party Risk

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Potential Liability for Wrongful-Birth Claims

On Nov. 14, 2012, in Sernovitz v. Dershaw, 2012 Pa. Super. 248 (Pa. Super. Ct. 2012), the Pennsylvania Superior Court held that 42 Pa.S.C.A. § 8305, which prohibited the tort claims of wrongful birth and wrongful life, was…more

Article III, Wrongful Birth

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Dogs: An Office's Best Friend?

Employers across the country are recognizing the benefits of pets, especially dogs, in the workplace and implementing policies that allow employees to bring their pet companions to work. Originally published in The Legal…more

ADA, Assistive Animals, Dog-Friendly Workplace, Dogs, Employee Benefits

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Amendments to Pennsylvania’s Uniform Condominium Act and Uniform Planned Communities Act

Recently, Pennsylvania Governor Tom Corbett signed into law House Bill 1122 (the "Amendment"), which amends the Uniform Condominium Act and the Uniform Planned Community Act (together the "Acts") by extending the time period for…more

Condominiums, New Legislation

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California Enacts Comprehensive Groundwater Management Legislation

On September 16, 2014, California Governor Jerry Brown signed into law a historic package of three bills—Senate Bill 1168, Senate Bill 1319 and Assembly Bill 1739—instituting comprehensive groundwater management in California…more

Drought, Environmental Policies, Groundwater, Water

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WellPoint Pays HHS $1.7 Million to Settle HIPAA Security Violations

Covered Entities Cautioned Regarding Use of Business Associates - On July 8, 2013, health insurer WellPoint, Inc. entered into a Resolution Agreement with the U.S. Department of Health and Human Services, Office for Civil…more

HHS, HIPAA, Policy Violations, Settlement, WellPoint

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FDA Draft Guidance Details Key Cybersecurity Management Measures Expected in Medical Device Submissions

Last month, the U.S. Food and Drug Administration (FDA) issued its Draft Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Recognizing the increasing need for effective…more

Cybersecurity, FDA, Medical Devices, Mobile Devices, Risk Management

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SEC Targets Investment Adviser Community

The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser…more

Chief Compliance Officers, Compliance, Corporate Counsel, Enforcement, Investment Adviser

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Use It or Lose It: U.S. Supreme Court Holds the SEC Must Bring Civil Enforcement Actions Within Five Years of Wrongful Conduct

On February 27, 2013, the United States Supreme Court put a stop to the Securities and Exchange Commission's (SEC) practice of bringing civil enforcement actions outside the five-year statute of limitations. In an opinion by…more

Civil Monetary Penalty, Discovery Rule, Gabelli v SEC, SCOTUS, SEC

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Pa. Superior Court Confirms Statutory Right of Repose for Improvements to Real Estate in Asbestos Cases

The Pennsylvania Superior Court reversed a jury verdict in favor of plaintiffs in an asbestos mesothelioma case, finding that the 12-year statute of repose bars all claims related to improvements constructed on real estate…more

Asbestos Litigation, Jury Verdicts, Reversal, Statute of Repose

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State Medicaid Fraud Control Units' Data Mining Likely to Increase Through Federal Funding

On May 17, 2013, the Office of Inspector General, U.S. Department of Health and Human Services (OIG), announced a final regulation that would permit, effective June 17, 2013, state Medicaid fraud control units (MFCU) to use…more

Affordable Care Act, Data Mining, Federal Funding, Fraud, Healthcare

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Amendments to Pennsylvania’s Uniform Condominium Act and Uniform Planned Communities Act

Recently, Pennsylvania Governor Tom Corbett signed into law House Bill 1122 (the "Amendment"), which amends the Uniform Condominium Act and the Uniform Planned Community Act (together the "Acts") by extending the time period for…more

Condominiums, New Legislation

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Immigration Impact: Recognizing and Reducing Liability in Corporate I-9 Procedures

2012 was a record year for Immigration and Customs Enforcement-Homeland Security Investigations (HSI), the agency charged with I-9 enforcement. In 2012, HSI commenced 3,004 I-9 investigations and completed 495, charging…more

Customs and Border Protection, DHS, Employer Liability Issues, Foreign Nationals, Fraud

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EU Debate over Cybersecurity Laws

We gave a progress report earlier this week in our Alert on the European Commission's plans for wide-ranging changes to data protection laws. It is worth remembering that the European Commission is also considering additional…more

Cybersecurity, EU, EU Data Protection Laws, European Commission

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Pa. Superior Court Confirms Statutory Right of Repose for Improvements to Real Estate in Asbestos Cases

The Pennsylvania Superior Court reversed a jury verdict in favor of plaintiffs in an asbestos mesothelioma case, finding that the 12-year statute of repose bars all claims related to improvements constructed on real estate…more

Asbestos Litigation, Jury Verdicts, Reversal, Statute of Repose

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Taking On The Internet For Your Client's Reputation

My cell phone rings at 6:30 on a Friday evening. It's the CEO of a client company and she is panicked. Hysterical. It turns out she was doing some "old-fashioned" investigating by performing Google searches on herself and the…more

DMCA, Reputation Management, Terms of Use, User-Generated Content, Websites

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Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug…more

Biologics, Biosimilars, FDA, Notice Requirements, Pharmaceutical

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New York Appeals Court Reverses Itself in K2 Investment Group Decision; Reaffirms Earlier Ruling in Servidone

In a decision notable for several reasons, the New York State Court of Appeals—the state's highest court—reversed itself in K2 Investment Group, LLC v. American Guarantee & Liability Insurance Co. [21 NY3d 384 (2014)] and…more

Breach of Duty, Duty to Defend, K2 Investment Group, Servidone

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UK Budget Speech - Key Points

The UK's Chancellor of the Exchequer, George Osborne, delivered his annual Budget Speech on 19 March 2014. More details of measures announced will be known when a new draft of the Finance Bill 2014 is published on 27 March. A…more

Economic Development, Tax Reform, UK

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"Every Breath" Theory: On Its Last Breaths?

The "every breath," or cumulative exposure opinion, has been proffered by plaintiffs' experts in asbestos cases to prove specific causation, regardless of the type of product or amount of exposure. The U.S. District Court for…more

Asbestos, Asbestos Litigation, Daubert Ruling, Every Breathe Theory, Evidence

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Second Circuit Ruling Appears to Limit Ability of U.S. Bankruptcy Courts to Assist Foreign Debtors

In Drawbridge Special Opportunities Fund LP v. Barnet (In re Barnet), Case No. 13-612, 2013 WL 6482499 (2d Cir. Dec. 11, 2013), the United States Court of Appeals for the Second Circuit held that in order for a foreign…more

Chapter 15, Commercial Bankruptcy, Debtors, Foreign Nationals

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"Who Wants to Be a Millionaire?" Profit-Sharing Verdict Upheld by Ninth Circuit

On December 3, 2012, the U.S. Court of Appeals for the Ninth Circuit in Celador International, Inc. v. American Broadcasting Companies, Inc., et al. upheld an interesting jury verdict, resulting in a $319 million judgment…more

License Agreements, Motion Picture Industry, Profit Sharing

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Second Circuit's Significant Decision Could Impact Liquidating Trustees

In the case of United States of America v. Edward P. Bond, No. 12-4803 (2d. Cir. August 13, 2014), the United States Court of Appeals for the Second Circuit (the "Second Circuit") issued a decision that could have far-reaching…more

Chapter 11, Commercial Bankruptcy, Liquidation, Trustees, Trusts

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U.S. Supreme Court Restricts Challenges to Pretrial Seizure of Defense Funds

The U.S. Supreme Court recently weakened a criminal defendant's ability to challenge the Government's pretrial seizure of assets that a defendant has allocated for mounting a defense. In Kaley v. United States, the Court…more

Frozen Assets, Kaley v. United States, Probable Cause, SCOTUS

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Strategic Perspectives: When is Telemedicine "Practicing Medicine" in Violation of the Law? An Emerging Framework for Compliance

Telemedicine is the future of health care, but under current law there is an open question: when does telemedicine constitute the unlawful “practice of medicine” in violation of state or other law? This question is critical for…more

Health Care Providers, Healthcare, Physicians, Professional License, Telemedicine

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Glaski Decision Appears to Place Lenders on Notice to Verify Accuracy and Effectiveness of Loan Assignments

The recent decision in Glaski v. Bank of America, National Association, et al., 160 Cal. Rptr. 3d 449 (2013), may, at least in certain circumstances, impact the ability of residential mortgage-backed security and commercial…more

Assignments, Bank of America, Lenders, Mortgage-Backed Securities, Mortgages

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Five Ways to Invite (and Avoid) a Malpractice Lawsuit

A recent headline in another leading legal publication asserted: "Malpractice claims are on the rise." As most lawyers know, it is not hard for even legally-aware professionals like themselves to be the defendants in a lawsuit…more

Attorney Malpractice, Career Development, Legal Ethics, Professional Liability

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SEC Eliminates Prohibition on General Solicitation in Certain Private Securities Offerings

On July 10, 2013, the U.S. Securities and Exchange Commission (the "SEC") (a) adopted final rules to implement Section 201(a) of the Jumpstart Our Business Startups Act by eliminating the prohibition on general solicitation in…more

General Solicitation, JOBS Act, Private Placements, Regulation D, Rule 144A

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A Guide to Regulation M: Regulating Market Activity During a Public Offering

Regulation M is intended to prevent potentially manipulative practices by underwriters, issuers, selling security holders and other participants in securities offerings. Understanding the key aspects of Regulation M is essential…more

Public Offerings, Regulation M, SEC, Securities Exchange Act

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Satisfaction Clauses -- A Trap For The Unwary In Terminating M&A Transactions

Your company might undertake a merger or acquisition for any number of reasons. It might wish to expand into new markets; to acquire valuable technology or other assets; and/or, of course, simply to grow the bottom line. No…more

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Automatic Stay Prevents Attachment of After-Acquired Judgment Lien

On Sept. 23, 2013, in Rodriguez v. Gelman (In re Local Service), 503 B.R. 136 (Bankr. D. Colo. 2013), the U.S. Bankruptcy Court for the District of Colorado addressed an issue of first impression in that district; namely,…more

Automatic Stay, Consumer Bankruptcy, Judgment Liens, Liens

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Q-and-A on Base Erosion and Profit Shifting

Base Erosion and Profit Shifting (BEPS) is currently the subject of intense discussion among tax professionals worldwide, but it remains a confusing area that is constantly evolving. This Alert highlights the key aims of BEPS,…more

BEPS, Erosion, OECD

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U.S. Supreme Court Restricts Challenges to Pretrial Seizure of Defense Funds

The U.S. Supreme Court recently weakened a criminal defendant's ability to challenge the Government's pretrial seizure of assets that a defendant has allocated for mounting a defense. In Kaley v. United States, the Court…more

Frozen Assets, Kaley v. United States, Probable Cause, SCOTUS

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Third-Party Software Providers— Will the DGE Take a Hard Look at Them?

Unlock your iPhone and today you can swipe through the plethora of apps from the multitude of independent software providers available at your fingertips. As our phones have transformed into ‘smart phones,’ other forms of…more

Casinos, Gaming, Gaming Equipment, Gaming Legislation, Independent Contractors

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Sunrise Periods for First Wave of gTLDs Are Now Open

ICANN, the International Corporation for Assigned Names and Numbers, has approved the first wave of generic top-level domains (gTLDs) for release. The introduction of new gTLDs triggers a mandatory 30-day "Sunrise Period" to…more

gTLD, ICANN, Trademark Clearinghouse, Trademarks

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FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human…more

DQSA, Drug Compounding, FDA, Pharmaceutical, Prescription Drugs

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Refill Reminder Exception to the Privacy Rule Created by the HITECH Act

The passing of the Health Information Technology for Economic and Clinical Health Act (HITECH) resulted in multiple changes regarding existing protection of protected health information (PHI) under the Health Insurance…more

HHS, HIPAA, HIPAA Omnibus Rule, HITECH, OCR

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Can an Employer Ask Employees to Keep HR Investigations Confidential?

Employee confidentiality during HR investigations is a "no-brainer" best practice – right? Not so fast – a recent decision by a labor board judge threatens to interfere with employers' ability to conduct investigations on a…more

Boeing, Confidential Employer Investigations, NLRA, NLRB, Section 7

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SBA Rules: Investment Funds Can Now Be Majority Owners of SBIR Companies

The Small Business Administration (SBA) recently amended the rules relating to its Small Business Innovation Research (SBIR) program and Small Business Technology Transfer (STTR) program. The new SBA rules implement the…more

Affiliates, Business Ownership, Hedge Funds, Investment Funds, Private Equity

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Congressional Approval of Mexico's Energy Reform Legislation

On August 6, 2014, the Mexican Congress finally approved secondary legislation (the "Legislation") providing for the implementation of the historic constitutional energy reforms in Mexico that were approved on December 20, 2013,…more

Energy, Energy Reform, Mexico

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A Bridge To Somewhere: Public Private Partnerships and America's Infrastructure Dilemma

Deferring infrastructure investment is not a viable option. Studies show that deferring timely maintenance, repair, and replacement can greatly increase the total cost of infrastructure repairs by a ratio of 15:1 to more than…more

Dams, Financing, Highways, Infrastructure, Legislative Agendas

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Recent Changes in New York City's Standard Construction Contract

With its new Standard Construction Contract, issued in December 2013, the City of New York (the "City") has implemented numerous significant changes as compared with its 2008 standard contract. This Alert briefly summarizes some…more

Construction Contracts, Construction Disputes, Contract Drafting, Prevailing Wages

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New Jersey Establishes Complex Business Litigation Program

The Supreme Court of New Jersey has announced the establishment of a Complex Business Litigation Program, effective January 1, 2015, with designated judges in each county assigned to provide individualized case management to…more

Business Court Division, Complex Litigation, Judges

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Five Ways to Invite (and Avoid) a Malpractice Lawsuit

A recent headline in another leading legal publication asserted: "Malpractice claims are on the rise." As most lawyers know, it is not hard for even legally-aware professionals like themselves to be the defendants in a lawsuit…more

Attorney Malpractice, Career Development, Legal Ethics, Professional Liability

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Supreme Court Establishes "Totality of the Circumstances" Framework for Determining Whether Attorney's Fees Should Be Shifted in Patent Cases

Also Holds That Review of Such Determinations Is for Abuse of Discretion - In a pair of companion cases decided on April 29, 2014, the U.S. Supreme Court provided key guidance on several significant issues concerning the…more

Attorney's Fees, Brooks Furniture, Exceptional Case, Fee-Shifting Statutes, Highmark v. Allcare

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Third-Party Software Providers— Will the DGE Take a Hard Look at Them?

Unlock your iPhone and today you can swipe through the plethora of apps from the multitude of independent software providers available at your fingertips. As our phones have transformed into ‘smart phones,’ other forms of…more

Casinos, Gaming, Gaming Equipment, Gaming Legislation, Independent Contractors

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Sweeping Changes to the Pennsylvania Tax Code - The Passage of Pa. House Bill 465

House Bill 465, also known as Act 52, was signed into law by Pennsylvania Governor Tom Corbett on July 9, 2013. The Bill makes substantial changes to the Pennsylvania tax code as an integral part of the 2013–2014 budget. While…more

Family Businesses, Income Taxes, Inheritance Tax, Net Investment Income, Pass-Through Entities

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FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User Fee…more

ANDA, FDA, GDUFA, Generic Drugs, Pharmaceutical

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Use It or Lose It: U.S. Supreme Court Holds the SEC Must Bring Civil Enforcement Actions Within Five Years of Wrongful Conduct

On February 27, 2013, the United States Supreme Court put a stop to the Securities and Exchange Commission's (SEC) practice of bringing civil enforcement actions outside the five-year statute of limitations. In an opinion by…more

Civil Monetary Penalty, Discovery Rule, Gabelli v SEC, SCOTUS, SEC

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IRS Announces Major Changes to Offshore Voluntary Disclosure Program

On June 18, 2014, the Internal Revenue Service (IRS) announced major changes in its offshore voluntary compliance programs. The changes include an expansion of the streamlined filing compliance procedures and key modifications…more

Disclosure Requirements, FBAR, IRS, Offshore Funds, OVDI

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Responding to Subpoena for Medical Records May Create Liability for Healthcare Providers Under State Law Negligence Claims

Healthcare providers receiving a subpoena for patient medical records may want to think twice before complying with the subpoena and producing the records. A recent Connecticut case, Byrne v. Avery Center for Obstetrics and…more

Health Care Providers, HIPAA, Medical Records, Negligence, Patient Privacy Rights

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The Success Checklist: What mHealth Investors and Entrepreneurs Should Know

A healthcare start-up developer has an intriguing concept for an app or a software solution. It may be an app tied to a sensor that is designed to transmit a diabetic's blood glucose levels to her physician, or an app that has a…more

Entrepreneurs, Health Information Technologies, Healthcare, Investors, mHealth

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CBP Issues Guidance on Acceptable Methods of Submitting Post-Importation Claims

As a follow-up to a memorandum issued by U.S. Customs and Border Protection (CBP) to its field offices on August 11, 2014, CBP has published a guidance to the trade community concerning "acceptable methods" for submission of…more

Customs and Border Protection, Free Trade Agreement, Imports, Trade Policy

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SEC Targets Investment Adviser Community

The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser…more

Chief Compliance Officers, Compliance, Corporate Counsel, Enforcement, Investment Adviser

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Public Benefit Corporations Open for Business in Delaware

Delaware is the 19th state to adopt a corporate business form for enterprises that wish to combine "for profit" pursuits and "public benefits." On August 1, 2013, Delaware began permitting the organization of for-profit…more

Choice of Entity, New Legislation, Non-Profits, Public Benefit Corporation

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District Court Clarifies Distinction Between Burdens of Proof on Stay Relief and Adequate Protection in American Airlines Bankruptcy

In AMR Corporation, et al., Debtors, Case No. 12-3967, 2013 WL 1339123 (S.D.N.Y. April 3, 2013), the United States District Court for the Southern District of New York acknowledged that to be granted relief from the automatic…more

Adequate Assurances, American Airlines, Burden of Proof, Chapter 11, Collateral

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mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary…more

FCC, FDA, FTC, Healthcare, HHS

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Home Is Where You Hang Your Hat: The Significance of Domicile Planning

A debtor, regardless of state residence, can seek protection from his or her creditors in the federal bankruptcy courts. However, the state in which the debtor resides or, more accurately, is "domiciled," will determine which…more

Debtors, Domicile, Estate-Tax Exemption, Exempt Assets, Financial Planning

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IRS Announces Major Changes to Offshore Voluntary Disclosure Program

On June 18, 2014, the Internal Revenue Service (IRS) announced major changes in its offshore voluntary compliance programs. The changes include an expansion of the streamlined filing compliance procedures and key modifications…more

Disclosure Requirements, FBAR, IRS, Offshore Funds, OVDI

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Pa. Superior Court Extends Protection of Implied Warranty of Habitability to Subsequent Purchasers of a Newly Constructed Home

For the first time, the Superior Court of Pennsylvania has extended the protection of the implied warranty of habitability to the second or subsequent purchaser of a newly constructed home in Conway v. The Cutler Group, 2012 Pa…more

Implied Warranty of Habitability, Latent Defects

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DEA Releases Final Rule on Disposal of Controlled Substances

On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the Secure and Responsible Drug…more

Controlled Substances Act, DEA, The Disposal Act

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SEC Enforcement Actions Against Private Equity: Get Ready for More

In a speech delivered at the Private Equity International Conference on January 23, 2013, in New York, Bruce Karpati, Chief of the U.S. Securities and Exchange Commission (SEC) Enforcement Division's Assets Management Unit,…more

Asset Management, Asset Valuations, CEOs, CFOs, Conflicts of Interest

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Automatic Stay Prevents Attachment of After-Acquired Judgment Lien

On Sept. 23, 2013, in Rodriguez v. Gelman (In re Local Service), 503 B.R. 136 (Bankr. D. Colo. 2013), the U.S. Bankruptcy Court for the District of Colorado addressed an issue of first impression in that district; namely,…more

Automatic Stay, Consumer Bankruptcy, Judgment Liens, Liens

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Public Works Projects and Municipal Bankruptcies

The good news is that public works construction projects for municipalities are projected to remain a major sector of construction activity for the foreseeable future. The not-so-good news is that municipal bankruptcy filings…more

Chapter 9, Construction Contracts, Creditors, Debtors, Executory Contracts

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Second Circuit's Significant Decision Could Impact Liquidating Trustees

In the case of United States of America v. Edward P. Bond, No. 12-4803 (2d. Cir. August 13, 2014), the United States Court of Appeals for the Second Circuit (the "Second Circuit") issued a decision that could have far-reaching…more

Chapter 11, Commercial Bankruptcy, Liquidation, Trustees, Trusts

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Maine Supreme Court Decision Limits Scope of MERS' Ability to Assign Mortgages

On July 3, 2014, the Maine Supreme Judicial Court issued a ruling in Bank of America, N.A. v. Greenleaf, 2014 ME 89 (Me. July 3, 2014), significantly affecting the ability of Mortgage Electronic Registration System, Inc. (MERS)…more

MERS, Mortgage Loan Originators, Mortgages

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Leave-of-Absence Issues Managers Need to Know

In many organizations, the human resources function is handled by specialists who guide managers' decision-making to ensure consistency with myriad employment laws. It is not uncommon, however, for HR professionals to get…more

ADA, FMLA, Hiring & Firing, Human Resources Professionals, Investigations

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D.C. Circuit Ruling Upholds New Ground Rules in Development of Electric Transmission Infrastructure

The Federal Energy Regulatory Commission's (FERC or "Commission") landmark regional electric transmission planning rulemaking, a multi-year effort by the Commission that has been met with vigorous opposition from some…more

Clean Power Plan, Electricity, Energy Policy, EPA, FERC

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IRS Announces Major Changes to Offshore Voluntary Disclosure Program

On June 18, 2014, the Internal Revenue Service (IRS) announced major changes in its offshore voluntary compliance programs. The changes include an expansion of the streamlined filing compliance procedures and key modifications…more

Disclosure Requirements, FBAR, IRS, Offshore Funds, OVDI

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Crowdfunding: Not as simple as it looks

In October, the Securities and Exchange Commission promulgated draft rules to implement “crowdfunding” in securities sales. Release 33-9470’s length (almost 600 pages) suggests that the simple idea contained in the 2012…more

Crowdfunding, JOBS Act, SEC

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U.S. Supreme Court Issues Significant Forum-Selection Decision

There has been confusion in the courts over the years regarding the appropriate mechanism to enforce forum-selection clauses, which are now routinely included in many commercial and personal contracts. Such clauses typically…more

Forum, Forum Selection Clause, SCOTUS

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D.C. Circuit Ruling Upholds New Ground Rules in Development of Electric Transmission Infrastructure

The Federal Energy Regulatory Commission's (FERC or "Commission") landmark regional electric transmission planning rulemaking, a multi-year effort by the Commission that has been met with vigorous opposition from some…more

Clean Power Plan, Electricity, Energy Policy, EPA, FERC

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Non-Binary Gender Identities in the Workplace

Gender fluid, gender variant, non-binary, agender, pangender—these are just a few examples of the more than 50 gender-identity options, beyond male and female, now available to users of Facebook. These genders do not, however,…more

Employee Rights, Employer Liability Issues, Facebook, Gender Identity, Sexual Orientation

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First ADA ATM Accessibility Class Action Lawsuit Is Filed in Atlanta

The first of what is likely to be many Americans with Disabilities Act (ADA) ATM accessibility class action lawsuits against Atlanta-area banks was filed in federal district court in Atlanta last week. The lawsuit was filed by…more

ADA, ATMs, Class Action

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SEC Enforcement Actions Against Private Equity: Get Ready for More

In a speech delivered at the Private Equity International Conference on January 23, 2013, in New York, Bruce Karpati, Chief of the U.S. Securities and Exchange Commission (SEC) Enforcement Division's Assets Management Unit,…more

Asset Management, Asset Valuations, CEOs, CFOs, Conflicts of Interest

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Federal Circuit Finds Computer Bingo Patents Invalid as Abstract Ideas

On August 26, 2014, the Federal Circuit ruled that patent claims regarding computer-aided management of bingo games are invalid because they are directed to a patent-ineligible abstract idea…more

Corporate Counsel

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Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug…more

Biologics, Biosimilars, FDA, Notice Requirements, Pharmaceutical

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New TCPA Rules Effective October 16, 2013

In 2012, the Federal Communications Commission (FCC) revised its regulations under the Telephone Consumer Protection Act ("TCPA"). On October 16, 2013, the final amendments to these regulations requiring prior express written…more

Cell Phones, Compliance, FCC, Robocalling, Spam

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Second Circuit Upholds "Neither Admit Nor Deny"

On June 4, 2014, the United States Circuit Court for the Second Circuit endorsed the Securities and Exchange Commission's practice of settling enforcement cases on a "neither admit nor deny" basis. In its order issued in SEC v…more

Admissions of Liability, Citigroup, Neither Admit Nor Deny Settlements, SEC, SEC v Citigroup

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Proceed with Caution When Foreclosing in Washington State: Split Decisions Regarding Deficiency Claims

Last week, the Washington Court of Appeals, Division One, ruled that, notwithstanding the anti-deficiency provision in the state's Deeds of Trust Act, a lender can pursue a deficiency judgment against a guarantor following a…more

Anti-Deficiency Provisions, Foreclosure, Mortgages

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Florida Legislature Unanimously Approves New Limited Liability Company Act

The Florida Legislature unanimously passed the new Florida Revised Limited Liability Company Act (the "New Act"), and Governor Rick Scott signed the bill into law on June 14, 2013. The New Act is codified as new Chapter 605 of…more

LLC, Operating Agreements, Rick Scott

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Cook County Use Tax Declared Invalid by Illinois Appellate Court

Affirming the decision of the circuit court, the Illinois Appellate Court struck down the Cook County Non-Titled Personal Property Use Tax (imposed last year) as violating Illinois law…more

Local Taxes, Property Tax, Sales & Use Tax, SALT

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Report to NAIC on Captives: The Controversy About Principle-Based Reserves and Captives Continues

The use by life insurance companies of captive reinsurance companies to finance XXX and AXXX reserves has been a significant and contentious issue in recent years. Some members of the National Association of Insurance…more

Captive Insurance Company, Life Insurance, NAIC, Reinsurance

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Appeals Court Strikes Down FCC's Net Neutrality Rules

On January 14, 2014, the U.S. Court of Appeals for the District of Columbia Circuit issued a long-awaited decision on the Federal Communications Commission's Open Internet Order. That Order required broadband Internet providers…more

Broadband, Cable Television Providers, Common Carriers, FCC, Internet

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FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do

On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved Abbreviated…more

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Businesses Around the United States Being Targeted for Alleged Inaccessible Websites

While plaintiff's lawyers have been busy the past two years filing lawsuits around the United States alleging violations of the Americans with Disabilities Act (ADA) related to physical barriers—including a wave of class action…more

ADA, ATMs, Banks, Class Action, Corporate Counsel

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Section 1113 Applies to Expired Collective Bargaining Agreements

Recently, in the case of In re Trump Entertainment Resorts, Bankruptcy No. 14-12103 (Bankr. D. Del. 2014), 2014 Bankr. LEXIS 4439 (Bankr. D. Del. October 20, 2014), the U.S. Bankruptcy Court for the District of Delaware…more

Bankruptcy Code, CBAs, Commercial Bankruptcy, NLRA, Resorts & Restaurants

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IRS Announces Major Changes to Offshore Voluntary Disclosure Program

On June 18, 2014, the Internal Revenue Service (IRS) announced major changes in its offshore voluntary compliance programs. The changes include an expansion of the streamlined filing compliance procedures and key modifications…more

Disclosure Requirements, FBAR, IRS, Offshore Funds, OVDI

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Five Ways to Invite (and Avoid) a Malpractice Lawsuit

A recent headline in another leading legal publication asserted: "Malpractice claims are on the rise." As most lawyers know, it is not hard for even legally-aware professionals like themselves to be the defendants in a lawsuit…more

Attorney Malpractice, Career Development, Legal Ethics, Professional Liability

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New Jersey Tax Sale Law Gives Purchaser of a Tax Sale Certificate a Tax Lien on the Underlying Property

The New Jersey Supreme Court, in In re: Princeton Office Park, L.P. v. Plymouth Park Tax Services, LLC, determined that under the Tax Sale Law, N.J.S.A. §§ 54:5-1 to -137, a purchaser of a tax sale certificate acquires a tax…more

Auction, Commercial Bankruptcy, Foreclosure, Municipalities, Tax Liens

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ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,…more

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UK Employment Appeal Tribunal Rules That Overtime Pay Should Be Included in Holiday Pay

The Employment Appeal Tribunal in the United Kingdom ruled today that in determining "pay" for the purposes of paid holiday entitlement for those undertaking their employment duties in the UK, remuneration for voluntary,…more

Employment Tribunals, Holiday Pay, UK

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Proceed with Caution When Foreclosing in Washington State: Split Decisions Regarding Deficiency Claims

Last week, the Washington Court of Appeals, Division One, ruled that, notwithstanding the anti-deficiency provision in the state's Deeds of Trust Act, a lender can pursue a deficiency judgment against a guarantor following a…more

Anti-Deficiency Provisions, Foreclosure, Mortgages

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Responding to Subpoena for Medical Records May Create Liability for Healthcare Providers Under State Law Negligence Claims

Healthcare providers receiving a subpoena for patient medical records may want to think twice before complying with the subpoena and producing the records. A recent Connecticut case, Byrne v. Avery Center for Obstetrics and…more

Health Care Providers, HIPAA, Medical Records, Negligence, Patient Privacy Rights

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IRS's Fresh Start Program: Opportunity to Resolve Unpaid Tax Obligations

Originally published in The Legal Intelligencer on March 15, 2013. Do you have clients, even friends and family, who may be facing serious financial difficulties and may be unable to pay previous or upcoming tax…more

Installment Agreements, IRS, Offers in Compromise, Penalties, Tax Returns

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Florida Legislature Unanimously Approves New Limited Liability Company Act

The Florida Legislature unanimously passed the new Florida Revised Limited Liability Company Act (the "New Act"), and Governor Rick Scott signed the bill into law on June 14, 2013. The New Act is codified as new Chapter 605 of…more

LLC, Operating Agreements, Rick Scott

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Shelter Dogs and Inmates Reinvent Themselves Together At New Leash On Life USA

Many organizations pair shelter dogs with inmates, often for the purpose of training and socializing the dogs to increase their adoption appeal. What makes New Leash on Life USA unique is its dedication to both the dogs and…more

Dogs, Inmates, New Leash on Life

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Sunrise Periods for First Wave of gTLDs Are Now Open

ICANN, the International Corporation for Assigned Names and Numbers, has approved the first wave of generic top-level domains (gTLDs) for release. The introduction of new gTLDs triggers a mandatory 30-day "Sunrise Period" to…more

gTLD, ICANN, Trademark Clearinghouse, Trademarks

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Overview of 2013 Amendments to HIPAA Privacy, Security, Breach Notification and Enforcement Rules

On January 17, 2013, the federal Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"), issued the long-anticipated final omnibus amendments (the "2013 Amendments") to the Privacy, Security, Breach…more

Business Associates, Covered Entities, Data Protection, Electronic Medical Records, Enforcement

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"Every Breath" Theory: On Its Last Breaths?

The "every breath," or cumulative exposure opinion, has been proffered by plaintiffs' experts in asbestos cases to prove specific causation, regardless of the type of product or amount of exposure. The U.S. District Court for…more

Asbestos, Asbestos Litigation, Daubert Ruling, Every Breathe Theory, Evidence

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Disclosure of Seed Sets: Required to Cooperate or Protected as Attorney Work Product?

The reliability and accuracy of the predictive coding process depends heavily on the identity of the documents in the seed set (including documents deemed irrelevant), because the seed set is the primary source used to teach the…more

Corporate Counsel, Document Productions, Predictive Coding

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What Amount of Deference, If Any, Is Accorded to CMS' Interpretation of the State Operations Manual?

On May 17, 2013, the United States Court of Appeals for the Fifth Circuit (Court) ruled on a Petition for Review of a Decision of the United States Department of Health and Human Services (DHHS) in the case styled, Elgin Nursing…more

Ambiguous, CMS, Food Safety, Handbooks, HHS

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Supreme Court Rejects Stipulation by Proposed Class Representative as Defeating Federal Removal Under Class Action Fairness Act of 2005

In a decision strengthening the ability of defendants in state court class actions to remove those cases to federal court, on March 19, 2013, a unanimous U.S. Supreme Court held in Standard Fire Insurance Company v. Knowles,1…more

Amount in Controversy, CAFA, Class Action, Damages, Jurisdiction

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IRS Announces Major Changes to Offshore Voluntary Disclosure Program

On June 18, 2014, the Internal Revenue Service (IRS) announced major changes in its offshore voluntary compliance programs. The changes include an expansion of the streamlined filing compliance procedures and key modifications…more

Disclosure Requirements, FBAR, IRS, Offshore Funds, OVDI

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Philadelphia's Energy Benchmarking Deadline Will Be at Your Doorstep This Halloween

For owners of commercial buildings of 50,000 square feet or more in the city of Philadelphia, chances are the time has come to address the city's new energy and water use benchmarking law. Energy benchmarking refers to a process…more

Benchmarks, Building Standards, Commercial Property Owners, Energy Efficiency, ENERGY STAR Program

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NAIC Moving Forward on Regulation of XXX/AXXX Financing Transactions

For more than two years, the National Association of Insurance Commissioners (the "NAIC") has been addressing the use by life insurers of captive reinsurers to finance reserves for certain term life insurance or universal life…more

Insurers, Life Insurance, NAIC, New Regulations, Reinsurance

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Seven Tips to Protect Your Facility from a False Claims Act Lawsuit

The False Claims Act is a federal law that imposes liability on persons and companies who make false claims for payment to the federal government. Many states have similar laws. The Act encourages whistleblowers to file suit on…more

False Claims Act, FERA, Internal Investigations, Medicaid, Medicare

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President Obama Vetoes U.S. International Trade Commission Exclusion Order of Apple Products

For the first time in 26 years, a U.S. president and his administration have exercised statutory authority to veto an exclusion order from the U.S. International Trade Commission (ITC). This development may herald the end of…more

Apple, Exclusions, ITC, Legislative Vetoes, Patents

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Federal Circuit Finds Computer Bingo Patents Invalid as Abstract Ideas

On August 26, 2014, the Federal Circuit ruled that patent claims regarding computer-aided management of bingo games are invalid because they are directed to a patent-ineligible abstract idea…more

Corporate Counsel

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Pennsylvania Mechanics' Lien Law Amended, Clarifying Open-End Construction Loan Mortgage Priority

On July 9, 2014, Pennsylvania Governor Tom Corbett signed into law Act 117 of 2014, which amends the Pennsylvania Mechanics' Lien Law (MLL), 49 P.S. 1101, et seq., to provide that a construction loan secured by an open-end…more

Construction Liens, Liens, Mechanics Lien, Mortgages, New Legislation

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Maine Supreme Court Decision Limits Scope of MERS' Ability to Assign Mortgages

On July 3, 2014, the Maine Supreme Judicial Court issued a ruling in Bank of America, N.A. v. Greenleaf, 2014 ME 89 (Me. July 3, 2014), significantly affecting the ability of Mortgage Electronic Registration System, Inc. (MERS)…more

MERS, Mortgage Loan Originators, Mortgages

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What's Next for Teaming Agreements After Cyberlock?

A recent federal District Court decision holding a teaming agreement between two contractors unenforceable under Virginia law raises questions about the usefulness of these commonly employed agreements—and not just in Virginia…more

Contract Drafting, Contract Interpretation, Contractors, Subcontractors, Teaming Agreements

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Guide to Publicly Offered Private Placements Under New Rule 506(c)

Background: A company that needs capital to expand its business or fund its operations often chooses to sell stock or other securities to investors in order to meet its funding requirements. All offerings of stock or…more

Bad Actors, Dodd-Frank, Filing Requirements, Investors, JOBS Act

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State Medicaid Fraud Control Units' Data Mining Likely to Increase Through Federal Funding

On May 17, 2013, the Office of Inspector General, U.S. Department of Health and Human Services (OIG), announced a final regulation that would permit, effective June 17, 2013, state Medicaid fraud control units (MFCU) to use…more

Affordable Care Act, Data Mining, Federal Funding, Fraud, Healthcare

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ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,…more

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FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User Fee…more

ANDA, FDA, GDUFA, Generic Drugs, Pharmaceutical

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SEC Enforcement Actions Against Private Equity: Get Ready for More

In a speech delivered at the Private Equity International Conference on January 23, 2013, in New York, Bruce Karpati, Chief of the U.S. Securities and Exchange Commission (SEC) Enforcement Division's Assets Management Unit,…more

Asset Management, Asset Valuations, CEOs, CFOs, Conflicts of Interest

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Looking Back on Appeals That Made a Difference

Originally published in the New York Law Journal on March 6, 2013. Almost 50 years have elapsed between my first and most recent appearance before the New York Court of Appeals and a recent LEXIS search shows I appeared…more

Appeals, Doctor-Patient Privilege, Drug Treatment, Felony Murder, First Amendment

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Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug…more

Biologics, Biosimilars, FDA, Notice Requirements, Pharmaceutical

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Second Circuit's Significant Decision Could Impact Liquidating Trustees

In the case of United States of America v. Edward P. Bond, No. 12-4803 (2d. Cir. August 13, 2014), the United States Court of Appeals for the Second Circuit (the "Second Circuit") issued a decision that could have far-reaching…more

Chapter 11, Commercial Bankruptcy, Liquidation, Trustees, Trusts

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IRS Announces Major Changes to Offshore Voluntary Disclosure Program

On June 18, 2014, the Internal Revenue Service (IRS) announced major changes in its offshore voluntary compliance programs. The changes include an expansion of the streamlined filing compliance procedures and key modifications…more

Disclosure Requirements, FBAR, IRS, Offshore Funds, OVDI

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Consider These Tips in Maximizing Your Charitable Tax Deduction

As you gather your tax materials and prepare to file your 2013 tax returns, you may wish to consider whether you have incurred out-of-pocket expenses while serving as a volunteer on behalf of a charitable organization. If so,…more

Charitable Deductions, IRS, Out-of-Pocket Expenses, Tax Returns, Transportation Expenses

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California Enacts Comprehensive Groundwater Management Legislation

On September 16, 2014, California Governor Jerry Brown signed into law a historic package of three bills—Senate Bill 1168, Senate Bill 1319 and Assembly Bill 1739—instituting comprehensive groundwater management in California…more

Drought, Environmental Policies, Groundwater, Water

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Recent Federal False Claims Act Decision Undermines Attorney-Client Privilege over Certain In-House Counsel Emails

A federal magistrate judge's recent decision in United States ex rel. Baklid-Kunz v. Halifax Hospital Medical Center, a Civil False Claims Act (“FCA”) case pending in the United States District Court for the Middle District of…more

Anti-Kickback Statute, Attorney-Client Privilege, Corporate Counsel, False Claims Act, Stark Law

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Businesses Around the United States Being Targeted for Alleged Inaccessible Websites

While plaintiff's lawyers have been busy the past two years filing lawsuits around the United States alleging violations of the Americans with Disabilities Act (ADA) related to physical barriers—including a wave of class action…more

ADA, ATMs, Banks, Class Action, Corporate Counsel

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Second Circuit Shifts Burden of Showing Assets to Defendants; Clarifies Monsanto Decision

Both civil and criminal agencies charged with enforcing U.S. laws have turned increasingly to broad based use of "asset freeze orders." Legal counsel and their clients should understand the issue, particularly as there is a…more

Attorney's Fees, Burden-Shifting, Forfeiture, Frozen Assets, Monsanto

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FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human…more

DQSA, Drug Compounding, FDA, Pharmaceutical, Prescription Drugs

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Group-Wide Global Insurance Capital Standards First Step - Basic Capital Mandate for G-SIIs

As the first step in the development of group-wide global insurance capital standards, the International Association of Insurance Supervisors (IAIS) released for public consultation its proposal on basic capital requirements…more

Capital Requirements, G-SII, Insurers, International Association of Insurance Supervisors

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HHS Issues Final Rules on Essential Health Benefits, Federal and Partnership Exchange Qualified Health Plan Accreditation Timeline and Actuarial Value

Essential Health Benefits - On February 20, 2013, the U.S. Department of Health and Human Services (HHS) issued a final rule that set the accreditation standards for qualified health plans (QHPs)—plans that will be…more

Actuarial Values, Affordable Care Act, Essential Health Benefits, Healthcare, HHS

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Pennsylvania Supreme Court Unanimously Holds That Union Workers Are Not Subcontractors for Purposes of Pa. Mechanics' Lien Law

On April 17, 2014, the Supreme Court of Pennsylvania issued a decision eagerly awaited by owners, developers, contractors and others involved in the construction industry…more

Liens, Mechanics Lien, Subcontractors, Unions

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Congressional Approval of Mexico's Energy Reform Legislation

On August 6, 2014, the Mexican Congress finally approved secondary legislation (the "Legislation") providing for the implementation of the historic constitutional energy reforms in Mexico that were approved on December 20, 2013,…more

Energy, Energy Reform, Mexico

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Corporations Don't Independently Owe Fiduciary Duties to Stockholders

On Aug. 7, Vice Chancellor Sam Glasscock III issued a letter opinion in the matter Buttonwood Tree Value Partners LP v. R.L. Polk & Co., C.A. No. 9250-VCL, that is not attention-grabbing because it wrestles with some nuanced…more

Breach of Duty, Fiduciary Duty, Shareholders

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Automation Systems and Product Liability: Best Practices

Originally published in Law360 on January 25, 2013. Contemporary theater depends increasingly on the "wow" factor. General audiences are no longer satisfied to see a great performance live without an associated visual…more

Automation Systems, Safety Precautions, Safety Training, Warranties

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The Applicability of the Massachusetts Wage Act Swells in June 2013

In late June 2013, the Massachusetts Supreme Judicial Court ("SJC") and the Massachusetts Appeals Court (the "Appeals Court") issued two decisions broadly expanding the breadth of the Massachusetts Wage Act (the "Wage Act") by…more

LLC, Penalties, Personal Liability, Wage Act, Wages

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Florida Legislature Unanimously Approves New Limited Liability Company Act

The Florida Legislature unanimously passed the new Florida Revised Limited Liability Company Act (the "New Act"), and Governor Rick Scott signed the bill into law on June 14, 2013. The New Act is codified as new Chapter 605 of…more

LLC, Operating Agreements, Rick Scott

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New Safety Test Requirements for Children's Products Become Effective in February 2013

Manufacturers and importers of children's products, including toys, apparel, sporting goods and jewelry, will soon be subject to yet another safety-testing regulation addressing several vital issues related to such testing: the…more

Consumer Product Safety Improvement Act, CPSC, Manufacturers, Penalties

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Recent Changes in New York City's Standard Construction Contract

With its new Standard Construction Contract, issued in December 2013, the City of New York (the "City") has implemented numerous significant changes as compared with its 2008 standard contract. This Alert briefly summarizes some…more

Construction Contracts, Construction Disputes, Contract Drafting, Prevailing Wages

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Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug…more

Biologics, Biosimilars, FDA, Notice Requirements, Pharmaceutical

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NAIC Moving Forward on Regulation of XXX/AXXX Financing Transactions

For more than two years, the National Association of Insurance Commissioners (the "NAIC") has been addressing the use by life insurers of captive reinsurers to finance reserves for certain term life insurance or universal life…more

Insurers, Life Insurance, NAIC, New Regulations, Reinsurance

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Consider These Tips in Maximizing Your Charitable Tax Deduction

As you gather your tax materials and prepare to file your 2013 tax returns, you may wish to consider whether you have incurred out-of-pocket expenses while serving as a volunteer on behalf of a charitable organization. If so,…more

Charitable Deductions, IRS, Out-of-Pocket Expenses, Tax Returns, Transportation Expenses

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A Bridge To Somewhere: Public Private Partnerships and America's Infrastructure Dilemma

Deferring infrastructure investment is not a viable option. Studies show that deferring timely maintenance, repair, and replacement can greatly increase the total cost of infrastructure repairs by a ratio of 15:1 to more than…more

Dams, Financing, Highways, Infrastructure, Legislative Agendas

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SEC Targets Investment Adviser Community

The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser…more

Chief Compliance Officers, Compliance, Corporate Counsel, Enforcement, Investment Adviser

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'Loan-to-Own' Strategy May Lead to Limitation on Credit-Bidding

On April 14, in In re Free Lance-Star Publishing, 512 B.R. 798 (Bankr. E.D. Va. 2014), the U.S. Bankruptcy Court for the Eastern District of Virginia considered the objection of Chapter 11 debtors to a secured creditor's right…more

Chapter 11, Commercial Bankruptcy, Credit Bids, Creditors

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Supreme Court Rejects Stipulation by Proposed Class Representative as Defeating Federal Removal Under Class Action Fairness Act of 2005

In a decision strengthening the ability of defendants in state court class actions to remove those cases to federal court, on March 19, 2013, a unanimous U.S. Supreme Court held in Standard Fire Insurance Company v. Knowles,1…more

Amount in Controversy, CAFA, Class Action, Damages, Jurisdiction

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Pets For Vets

We owe so much to the men and women who have fought for our country. In addition to the many who have died, many others come home with physical and emotional disabilities. It is estimated that up to 20% return with Post…more

Assistive Animals, Pets for Vets, PTSD, Service Animals, Veterans

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New Jersey Bill Requires Creditors to Maintain Vacant Property During Pending Foreclosures

Effective July 14, 2014, New Jersey municipalities will be authorized to penalize creditors who do not address code violations or abate nuisances on vacant or abandoned residential property subject to a pending foreclosure…more

Abandoned Property, Foreclosure, Mortgages, Nuisance

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Potential Liability for Wrongful-Birth Claims

On Nov. 14, 2012, in Sernovitz v. Dershaw, 2012 Pa. Super. 248 (Pa. Super. Ct. 2012), the Pennsylvania Superior Court held that 42 Pa.S.C.A. § 8305, which prohibited the tort claims of wrongful birth and wrongful life, was…more

Article III, Wrongful Birth

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Treasury and IRS Recognize Same-Sex Marriage for All Federal Tax Purposes

On August 29, 2013, the U.S. Department of the Treasury and the Internal Revenue Service (IRS) issued Revenue Ruling 2013-17, declaring that same-sex couples legally married in a jurisdiction that recognizes same-sex marriage…more

DOMA, IRS, Marriage, Same-Sex Marriage, SCOTUS

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When Athletes Retire, Is the Next Step Bankruptcy or Paradise?

The "paradise" stories for the post-playing careers of professional athletes are without a doubt under told. The success of Roger Staubach in building a real estate empire, the multiple businesses of NBA all-stars Magic Johnson…more

Athletes, Financial Planning, Retirement, Sports, Tax Planning

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Legal Briefs - False Claims Act Liability for CRNAs Related to Medical Direction

It has never been a secret to Certified Registered Nurse Anesthetists (CRNAs) that anesthesiologists are often not able to consistently comply with all of the requirements of TEFRA (Tax Equity and Fiscal Responsibility Act of…more

False Claims Act, Healthcare Professionals, Nurses, Professional Liability, Tax Liability

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Guide to Publicly Offered Private Placements Under New Rule 506(c)

Background: A company that needs capital to expand its business or fund its operations often chooses to sell stock or other securities to investors in order to meet its funding requirements. All offerings of stock or…more

Bad Actors, Dodd-Frank, Filing Requirements, Investors, JOBS Act

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mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary…more

FCC, FDA, FTC, Healthcare, HHS

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EU Debate over Cybersecurity Laws

We gave a progress report earlier this week in our Alert on the European Commission's plans for wide-ranging changes to data protection laws. It is worth remembering that the European Commission is also considering additional…more

Cybersecurity, EU, EU Data Protection Laws, European Commission

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Supreme Court Rejects Stipulation by Proposed Class Representative as Defeating Federal Removal Under Class Action Fairness Act of 2005

In a decision strengthening the ability of defendants in state court class actions to remove those cases to federal court, on March 19, 2013, a unanimous U.S. Supreme Court held in Standard Fire Insurance Company v. Knowles,1…more

Amount in Controversy, CAFA, Class Action, Damages, Jurisdiction

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Principle-Based Reserves & SPVs: Regulatory Developments

In a Duane Morris Alert dated December 7, 2012, we addressed developments at the fall meeting of the National Association of Insurance Commissioners (NAIC) relating to principle-based reserves (PBR) and the draft White Paper on…more

Federal Insurance Office, NAIC, Principle-Based Reserves, Special Purpose Vehicles

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The Efforts to Legalize Sports Betting in New Jersey—A History

A complex and expensive battle between the National Collegiate Athletic Association (NCAA) and the four major professional sports leagues and the state of New Jersey over whether New Jersey’s casinos and racetracks can offer…more

Amended Legislation, NCAA, PASPA, Sports, Sports Betting

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Supreme Court Holds FDCA Preempts Common Law Design-Defect Claim Against Generic Drugs

On June 24, 2013, the U.S. Supreme Court held in Mutual Pharmaceutical Co., Inc. v. Bartlett that the Federal Food, Drug, and Cosmetic Act (FDCA) preempted the respondent's common law claim for damages arising from the alleged…more

Design Defects, Drugs, FDA, FDCA, Generic Drugs

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Marketplace Fairness Act of 2013 Passes United States Senate

On May 6, 2013, the United States Senate passed the Marketplace Fairness Act of 2013 (the "Act") by a vote of 69 to 27. The legislation (S. 743) now moves to the House of Representatives for consideration…more

Due Process, Equal Protection, Internet Retailers, Marketplace Fairness Act, Proposed Legislation

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The Applicability of the Massachusetts Wage Act Swells in June 2013

In late June 2013, the Massachusetts Supreme Judicial Court ("SJC") and the Massachusetts Appeals Court (the "Appeals Court") issued two decisions broadly expanding the breadth of the Massachusetts Wage Act (the "Wage Act") by…more

LLC, Penalties, Personal Liability, Wage Act, Wages

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Q-and-A on Base Erosion and Profit Shifting

Base Erosion and Profit Shifting (BEPS) is currently the subject of intense discussion among tax professionals worldwide, but it remains a confusing area that is constantly evolving. This Alert highlights the key aims of BEPS,…more

BEPS, Erosion, OECD

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Federal Circuit Finds Computer Bingo Patents Invalid as Abstract Ideas

On August 26, 2014, the Federal Circuit ruled that patent claims regarding computer-aided management of bingo games are invalid because they are directed to a patent-ineligible abstract idea…more

Corporate Counsel

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FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do

On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved Abbreviated…more

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Representing the Targeted Executive: Diplomacy Matters

It seemed like a good idea. Provide a local media outlet with a peek under the company's hood—give a tour of the facilities, answer questions about operations, preview a few promising transactions. When the article ran, however,…more

Attorney-Client Privilege, Board of Directors, Corporate Counsel, Enforcement, Enforcement Actions

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Community Colleges Not Subject to UTPCPL

It only stands to reason, yet it took almost 12 years and repeated appeals for the final determination by the Pennsylvania Supreme Court in Meyer v. Community College of Beaver County, No. 22 WAP 2012, 2014 Pa. LEXIS 1524 (Pa…more

Community Colleges, Exemptions, Public Entities, Tort Claims Act, Unfair or Deceptive Trade Practices

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Maine Supreme Court Decision Limits Scope of MERS' Ability to Assign Mortgages

On July 3, 2014, the Maine Supreme Judicial Court issued a ruling in Bank of America, N.A. v. Greenleaf, 2014 ME 89 (Me. July 3, 2014), significantly affecting the ability of Mortgage Electronic Registration System, Inc. (MERS)…more

MERS, Mortgage Loan Originators, Mortgages

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WellPoint Pays HHS $1.7 Million to Settle HIPAA Security Violations

Covered Entities Cautioned Regarding Use of Business Associates - On July 8, 2013, health insurer WellPoint, Inc. entered into a Resolution Agreement with the U.S. Department of Health and Human Services, Office for Civil…more

HHS, HIPAA, Policy Violations, Settlement, WellPoint

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Florida Legislature Unanimously Approves New Limited Liability Company Act

The Florida Legislature unanimously passed the new Florida Revised Limited Liability Company Act (the "New Act"), and Governor Rick Scott signed the bill into law on June 14, 2013. The New Act is codified as new Chapter 605 of…more

LLC, Operating Agreements, Rick Scott

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Second Circuit Ruling Appears to Limit Ability of U.S. Bankruptcy Courts to Assist Foreign Debtors

In Drawbridge Special Opportunities Fund LP v. Barnet (In re Barnet), Case No. 13-612, 2013 WL 6482499 (2d Cir. Dec. 11, 2013), the United States Court of Appeals for the Second Circuit held that in order for a foreign…more

Chapter 15, Commercial Bankruptcy, Debtors, Foreign Nationals

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Fifth Circuit to Dodd-Frank Whistleblowers: Call the SEC First

The U.S. Court of Appeals for the Fifth Circuit's decision last week in Asadi v. G.E. Energy (USA) has been hailed as a win for employers because it requires whistleblowers who bring retaliation claims under the Dodd–Frank Wall…more

Adverse Employment Action, Dodd-Frank, Retaliation, SEC, Whistleblower Protection Policies

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Rollovers as Business Startups: A Guide to Using Retirement Funds to Start a Business

Over the past 10 years, thousands of entrepreneurs have used their existing retirement savings held by a qualified retirement plan or IRA to finance the startup or acquisition of a new business. According to industry experts in…more

401k, Business Formation, Entrepreneurs, IRA, Retirement

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Disclosure of Seed Sets: Required to Cooperate or Protected as Attorney Work Product?

The reliability and accuracy of the predictive coding process depends heavily on the identity of the documents in the seed set (including documents deemed irrelevant), because the seed set is the primary source used to teach the…more

Corporate Counsel, Document Productions, Predictive Coding

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UK Employment Appeal Tribunal Rules That Overtime Pay Should Be Included in Holiday Pay

The Employment Appeal Tribunal in the United Kingdom ruled today that in determining "pay" for the purposes of paid holiday entitlement for those undertaking their employment duties in the UK, remuneration for voluntary,…more

Employment Tribunals, Holiday Pay, UK

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The One Mistake Startup Entrepreneurs Always Make - A Legal Perspective...

In your experience working with startup entrepreneurs, what's the one mistake they make time and again? The answer to that question of course varies greatly, depending on whom you ask - and, for legal perspective, we put…more

Business Formation, Legal Perspectives, Shareholders' Agreements, Startups

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FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public…more

ANDA, FDA, Pharmaceutical Patents, Prescription Drugs

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Home Is Where You Hang Your Hat: The Significance of Domicile Planning

A debtor, regardless of state residence, can seek protection from his or her creditors in the federal bankruptcy courts. However, the state in which the debtor resides or, more accurately, is "domiciled," will determine which…more

Debtors, Domicile, Estate-Tax Exemption, Exempt Assets, Financial Planning

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SEC Targets Investment Adviser Community

The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser…more

Chief Compliance Officers, Compliance, Corporate Counsel, Enforcement, Investment Adviser

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IRS Announces Major Changes to Offshore Voluntary Disclosure Program

On June 18, 2014, the Internal Revenue Service (IRS) announced major changes in its offshore voluntary compliance programs. The changes include an expansion of the streamlined filing compliance procedures and key modifications…more

Disclosure Requirements, FBAR, IRS, Offshore Funds, OVDI

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Areas of Practice
  • Administrative Law
  • Alternative Dispute Resolution (ADR)
  • Antitrust & Trade Regulation
  • Appellate Practice
  • Bankruptcy
  • Business Organizations
  • Commercial Law & Contracts
  • Construction Law
  • Debtor/Creditor
  • Education
  • Energy & Utilities
  • Environmental Law
  • Finance & Banking
  • Government
  • Health
  • Immigration Law
  • Insurance
  • Intellectual Property
  • International Law & Trade
  • Labor & Employment Law
  • Litigation
See more
Locations
Other U.S. Locations
  • California
  • D.C.
  • Delaware
  • Florida
  • Georgia
  • Illinois
  • Maryland
  • Massachusetts
  • Nevada
  • New Jersey
  • New York
  • Pennsylvania
  • Texas
Other Countries
  • Singapore
  • United Kingdom
  • Vietnam
Number of Attorneys

400+ Attorneys

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