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Update in Janssen v. Celltrion: Parties Stipulate that Celltrion Will Not Sell Remicade Biosimilar Before October 3, 2016

In a stipulation filed yesterday in Janssen v. Celltrion, Celltrion has agreed not to sell its Remicade biosimilar in the U.S. for use by doctors or patients before October 3, 2016, and the parties have agreed to dismiss all claims and…more

SEC Charges Private Equity Advisers With Inadequate Disclosure

The Commission has brought a series of cases against private equity centered on undisclosed fees and conflicts of interest – key areas of interest during OCIE exams. The latest proceeding in this string of cases involves four private…more

NLRB Allows Private University Students to Unionize

The National Labor Board of Relations decision released on Aug. 23, 206, will have far-reaching consequences for private universities and colleges. The decision promises to be a potential source of litigation and headaches for college…more

A Primer on EB-5 and Key Issues in its Renewal

What is the EB-5 Immigrant Investor Visa Program? The EB-5 immigrant investment visa program provides a “fast track” to obtain permanent U.S. residency (a “green card”) to qualified foreign investors who satisfy specified…more

EEO-1 Reports: Time for Employers to Get in Formation

This is the time of year when employers with 100 or more employees and federal contractors with 50 or more employees must prepare and file their annual EEO-1 reports – documents that provide the government with details regarding…more

Consider Your Options for Charitable Giving - Trusts and Estates Update Volume 2016, Issue 1

There are many charitable giving options that are available to fit a donor’s specific goals. You do not have to be Bill Gates or Warren Buffett to make a difference in the world now and after you are gone. Most of our clients are…more

Litigating with the Government: A Different Kind of Plaintiff

Effectively defending a client from an attack by the government requires an understanding of how the government’s priorities differ from those of a commercial litigant and then building your case around that…more

STOLI Policies Cancelled, Insurers Retain Premium

Two federal appellate courts have affirmed, on different grounds, the cancellation of large life insurance policies that were alleged to be stranger originated life insurance (STOLI), permitting the issuing insurers to retain the…more

FCC Enforcement Monitor ~ August 2016

Pillsbury’s communications lawyers have published FCC Enforcement Monitor monthly since 1999 to inform our clients of notable FCC enforcement actions against FCC license holders and others. This month’s issue includes: -…more

California: Making Arbitration Great Again

California’s resistance to the longstanding federal policy favoring arbitration frequently results in public expressions of frustration by the justices of the U.S. Supreme Court. In over five years since the Supreme Court’s broad…more

California Supreme Court Salvages Precondemnation Entry Statute by Reforming to Include Right to Jury

It is not often that the California Supreme Court steps in to reform legislation that would otherwise be unconstitutional, but that’s what it did in Property Reserve, Inc. v. Superior Court (S.Ct. No. S217738), issued July 21, 2016…more

CFPB Revises Methodology Statement for Calculating Average Prime Offer Rates

The Consumer Financial Protection Bureau (CFPB) has published a notice in the Federal Register announcing that it has revised its methodology statement for calculating the average prime offer rates (APORs) under Regulations C and Z…more

Greater Flexibility in Challenging Pipeline Takings

The standards contained in the Uniform Condemnation Procedures Act allow greater flexibility to trial judges when evaluating the necessity of a pipeline taking than other takings. Since initially writing this post, as a result of…more

Streamlined Procedures for Authenticating Documents in Brazil

Brazil has become the 111th contracting state to the 1961 Hague Convention Abolishing the Requirement of Legalization for Foreign Public Documents (the "Convention"). The text of the Convention was approved by the Brazilian Federal…more

The NLRB Opens the Door to Union Organizing Among Teaching Assistants and Other Student Assistants at Private Colleges and Universities

In what will come as no surprise to even the most casual labor law observer, yesterday the National Labor Relations Board jettisoned established precedent and granted teaching assistants and other student assistants at private higher…more

CPSC Recall Snapshot: August 2016

Welcome to the August edition of the Alston & Bird CPSC Recall Snapshot. The number of products subject to recalls this year is on pace to dwarf the number of recalled units in recent years. On the heels of the recent IKEA recall…more

Ninth Circuit Finds Arbitration Agreement That Required Employees to Bring Claims in “Separate Proceedings” Illegal Under the NLRA

On August 22, 2016, in Morris et al. v. Ernst & Young, LLP, a panel of the U.S. Court of Appeals for the Ninth Circuit followed the lead of the National Labor Relations Board (“NLRB”) and the U.S Court of Appeals for the Seventh…more

Hallmark 3 – Oversight, Autonomy and Resources

I. Autonomy - The DOJ has made clear over the years the importance of this hallmark. In the FCPA Guidance it states, “In appraising a compliance program, DOJ and SEC also consider whether a company has assigned respon­sibility…more

False Claims Act Cases: With No End In Sight, Why You Should Consider Litigating And How To Maximize Your Litigation Advantages

Over the past few years, the government’s emphasis on conducting fraud and abuse investigations – especially in the healthcare industry – has resulted in scores of settlements and billions of dollars paid to the government under the…more

Lead Change or Hang On for Dear Life

Change is. Years ago, many people debated whether the legal industry was changing. Truth be told, the debate was silly. Change is. The only question is the speed of change. It used to be slow. It took years to move from fountain…more

Texas SWDA Preempts Plastic Bags-Related Ordinance

On August 17, 2016, the Fourth District Court of Appeals sitting in San Antonio held, in a 2 to 1 decision, that a City of Plastic bagsLaredo ordinance prohibiting the distribution of “single use” plastic bags at check-out counters in…more

Ninth Circuit Revives RMBS Claims Against Nomura

On August 15, 2016, the Ninth Circuit Court of Appeals vacated the Central District of California’s order dismissing claims brought by the National Credit Union Administration Board (“NCUA”), as liquidating agent of Western Corporate…more

Defending a Data Breach Investigation by the Federal Trade Commission

Your company has experienced a data breach, and the Federal Trade Commission (“FTC”) notifies you that it is initiating a non-public investigation. How the company responds can significantly affect the course of the investigation and…more

HIPAA Phase 2 Audits: What Has OCR Requested from Auditees to Date?

In our April 8, 2016, advisory, we discussed the U.S. Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) “Phase 2” audit program. Then, we could only make educated guesses about what documents OCR would likely…more

2016 Draft Instructions For 1094-B and 1095-B

Last week, the IRS released draft 2016 instructions for the 1094-B and 1095-B (the “B” Forms). The release of the draft instructions is just weeks after the IRS released the draft instructions for the 1094-C and 1095-C Forms. (see our…more

Universities: Growing Concern With Explosion of Retirement Plan Fee-Related Lawsuits

In a concerning development for universities and other institutions of higher learning nationwide, a growing number of schools, including Massachusetts Institute of Technology, New York University, Yale University, Johns Hopkins…more

The Problem with Prospective Injunctive Relief

There are several practices in class action litigation that really only work if you squint real hard and accept that, as a practical if not a doctrinal matter, class actions are just “different” than other litigation. These practices…more

United States District Court Enjoins Enforcement of Dear Colleague Letter on Transgender Students; Decision May Impact OCR Guidance on Sexual Violence

On August 21, 2016, in a case entitled State of Texas et al. v. United States of America et al ., Judge Reed O’Connor of the United States District Court for the Northern District of Texas issued a nationwide preliminary injunction…more

Consumer Group Questions Kardashian Posts

On Monday, a consumer advocacy group announced that it had sent a letter to the Kardashian-Jenner family challenging how the sisters promote products on Instagram. The group contends that the sisters have engaged in deceptive…more

Review Published of Nanomaterials for Products and Application in Agriculture, Feed, and Food in the European Union

The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors. The results of the review are published in the August 2016 issue of…more

CFPB to Participate in FTC Workshop on Consumer Disclosures

On September 15th, the FTC will hold a workshop to examine the testing and evaluation of disclosures that companies make to consumers about advertising claims, privacy practices, and other information. The FTC’s workshop will explore…more

Changes in Cuba May Impact the Insurance Industry

While much remains to be determined, the recent easing of U.S. restrictions on travel to and trade with Cuba may bring opportunities for U.S. and global insurance companies. However, many questions and obstacles remain. This article…more

Singapore Legal Update - August 2016

MAS Proposes Enhancements to the Regulatory Requirements on Protection of Customer’s Moneys and Assets - The MAS Consultation Paper on Enhancements to the Regulatory Requirements on Protection of Customer’s Moneys and Assets…more

OSHA’s Fact Sheet Providing Guidance to Employers To Protect Workers from Exposure to the Zika Virus

OSHA’s Fact Sheet providing guidance for protecting workers from occupational exposure to the Zika virus explains that the Zika virus is primarily spread through the bites of infected mosquitoes and that mosquitoes can become infected…more

Court of Chancery Explains Some Consequences For Violating Forum Selection Agreement

This is a significant decision because it explains how filing suit somewhere other than in the contractually-designated jurisdiction does not toll the time to sue in the proper jurisdiction. Hence, if the improperly-filed suit is…more

ISDA Launches 2016 Variation Margin Protocol to Facilitate Compliance With Margin Rules

On August 16, 2016, the International Swaps and Derivatives Association, Inc. (ISDA) published the ISDA 2016 Variation Margin Protocol (VM Protocol). The VM Protocol will help market participants implement the new variation margin…more

Ninth Circuit Denies EPA’s Request for Six-Month Extension on Chlorpyrifos Decision; Grants Three-Month Extension

On August 12, 2016, a three-judge panel of the Ninth Circuit Court of Appeals issued an order denying the U.S. Environmental Protection Agency’s (EPA) request for an additional six months to decide whether to ban agricultural uses of…more

Singapore Legal Update - July 2016

A Conditional Primary Obligation to Pay Is Not a Penalty - In iTronic Holdings Pte Ltd v Tan Swee Leon [2016] SGHC 77 (Singapore High Court, 21 April 2016), the Singapore High Court held that an obligation to pay a specified…more

Policy for Employee Theft Including Forgery Doesn’t Cover Employee Forgery

A seller extends $90 million in credit to a customer, secured by letters of credit. When the debtor can’t pay, the seller discovers the instruments are fakes, forged by its own employee. Can the seller recover under a policy that…more

FinCEN Expands Crackdown on Real Estate Buyers

Building on early successes, the Financial Crimes Enforcement Network (“FinCEN”) announced new rules targeting buyers of high-end real estate properties. Earlier this year, FinCEN adopted rules focusing on high-end buyers of real…more

[Video]Ten Hallmarks of an Effective Compliance Program-Hallmark 3

In this 10-episode podcast series I take a look at all ten hallmarks of an effective compliance program as set out in the FCPA Guidance. In this episode I review Hallmark 3 - Oversight, Autonomy and Resources…more

ATTENTION PROPERTY OWNERS: Your Property Tax (TRIM) Notices for 2016 Have Been Mailed To You!

August 23, 2016 By: S. Brendan Lynch Property Appraisers in Florida have now sent out Truth in Millage (TRIM) notices to all property owners, so these notices have either already been received or will be waiting in your mailbox…more

Hundreds Erupt in Elation After Sterling Heights Mosque Denial

In the RLUIPA Round-Up post, we noted that the City of Sterling Heights, Michigan, is facing a federal lawsuit following its denial of the American Islamic Community Center’s (Center) zoning application to build a 20,500 square foot…more

Penalties Increased for Employee Benefit Plan Violations

Recently-enacted legislation has increased many penalty amounts for certain employee benefit plan violations. The new penalties – some of which are more than double previous amounts – were adjusted to catch up with inflation and…more

OSHA Pilots New Expedited Whistleblower Process – Will Allow Complainants to Request Judicial Review

Seyfarth Synopsis: The DOL announced this week its new Whistleblower expedited Case review pilot process, to be conducted in its Region 9. Employers in this region may now anticipate even more cases going to the ALJ’s, and should watch…more

Transgender Claim Meets Dress Code

The worlds of transgender versus religious rights collided hard recently when an EEOC action on behalf of a discharged transgender worker ran full force into a Religious Freedom Restoration Act (“RFRA”) defense, and the EEOC lost…more

#Fired: Post a Tweet, Lose Your Job

Many people enjoy spouting off what they view as 140-character tidbits of wisdom on the social media platform Twitter. But recently several individuals have found themselves in trouble with their employers (read: former employers) for…more

Complying with Advertising Laws when Marketing Children's Products

We are now in the midst of the back-to-school season, and before you know it, Halloween and the winter holiday season will be upon us. Over these next few months in particular, companies may face a variety of issues related to the…more

Proposed Section 2704 Regulations

On August 2, 2016, the Treasury Department released proposed regulations amending and expanding upon the current regulations to Internal Revenue Code Section 2704. The proposed regulations, if adopted, would affect the valuation of…more

Minister or Not? Gay Bias Case Turns on Employee’s Role

Seyfarth Synopsis: A federal judge has allowed a discrimination lawsuit to proceed against the Archdiocese of Chicago. The plaintiff alleges that his engagement to another man resulted in his termination. The church sought to dismiss…more

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