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Amgen v. Sandoz: Federal Circuit Interprets “Patent Dance” Provisions of BPCIA to Permit Biosimilar Applicant to Refuse to Disclose Application and Manufacturing Information

One-Hour Briefing  One-Hour Briefing

The Court of Appeals for the Federal Circuit interpreted for the first time provisions relating to patent infringement contained in the Biologic Products Competition and Innovation Act (BPCIA) in Amgen v. Sandoz.  Although the decision was seriously fractured, the consequences are clear.  First, a biosimilar applicant is not required to disclose to the reference product sponsor (i.e., the innovator biologic drug maker, RPS) either its application ...

Obtaining Design Rights Using the Hague System: A Guide for U.S. Practitioners

One-Hour Briefing  One-Hour Briefing

The United States Patent and Trademark Office (USPTO) began accepting applications under The Hague Agreement on May 13, 2015. Under The Hague Agreement, U.S. applicants may now apply for design protection in more than 60 jurisdictions by filing a single International Design Application (IDA) in English with the USPTO.  However, filing an IDA under The Hague Agreement is not something to attempt without some significant planning up front.  ...

Home Court Advantage: Recent Developments and Strategies for Litigants Concerning the SEC’s Increasing Use of Administrative Proceedings

One-Hour Briefing  One-Hour Briefing

Since the 2010 passage of the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Securities and Exchange Commission has used its expanded authority to increasingly bring its enforcement actions in administrative proceedings before SEC-appointed administrative law judges, rather than in federal district court.  Recent news reports and defense bar commentary have described the SEC’s high rate of success in cases heard by ALJ’s ...

Emerging Risk Management and Litigation Issues for Health Care Organizations: What Keeps Us Up at Night?

One-Hour Briefing  One-Hour Briefing

In an ideal world, the health care sector could focus exclusively on its core mission: providing high-quality care, treatment, services, supplies, and products to improve patients’ health and lives. But increased competitive dynamics, expanding government oversight, and evolving business complexities introduce legal risk at every turn. These challenges call for the incorporation of risk management strategies into every business decision. When ...

Six “P’s” of Professional Legal Writing

One-Hour Briefing  One-Hour Briefing

Writing well takes commitment, practice, hard work, and a solid writing process. For many lawyers, writing well does not come easy. Lawyers also write for sophisticated and discerning readers: judges and clients.   This session covers the six “P”s of professional legal writing: Professional, Practice, Process, Preference, Placement and Punctuation. Lawyers must realize and embrace they are Professional writers. As professional ...

SEC Enforcement of Trading in Pre-IPO Securities

One-Hour Briefing  One-Hour Briefing

Just within the past 5 years, there has been an explosion in trading in the shares of private, pre-IPO companies.  Insiders at companies looking for liquidity have found rapturous investors looking to get a piece of hot new companies before they go public.  To facilitate these sales, new on-line marketplaces have sprung up to match buyers and sellers, and to start funds akin to mutual funds, only with pre-IPO shares.   This trend ...

SEC's Pay Ratio Rule: What Companies Need to do to Prepare

One-Hour Briefing  One-Hour Briefing

On August 5, 2015, the SEC issued a long-awaited final rule to implement the Dodd-Frank requirement that issuers disclose the median annual total compensation of all their employees (minus the chief executive officer), the annual total compensation of their CEO, and the ratio of these two amounts.  The SEC’s final rule contains some significant changes from the rule proposed in 2013, most of which were designed to provide issuers with additional ...

August 2015 Amendments to the DGCL: Critical Changes Concerning Forum Selection and Fee Shifting Bylaws in Delaware

One-Hour Briefing  One-Hour Briefing

In the face of increasing stockholder litigation, companies have utilized various tools in an attempt to limit the extent of litigation generally, and multiforum litigation, in particular.  Companies have adopted provisions in their governing documents that (1) specify the forum or forums in which stockholder litigation can occur, and (2) impose fee shifting in connection with any such litigation.  Following several high-profile decisions ...

Anti-Money Laundering: Fundamentals of U.S. Law and Compliance

One-Hour Briefing  One-Hour Briefing

Money laundering involves financial transactions with the proceeds of criminal activity.  Yet, contrary to popular perception, money laundering predicate offenses include not only drug trafficking, terrorist finance, and violent crimes like racketeering, murder, terrorism, and human trafficking, but also a wide range of white collar crimes including mail and wire fraud, Foreign Corrupt Practices Act violations, tax offenses, illegal gambling ...

In-House Counsel and Pro Bono -- Making the Match (Free)

One-Hour Briefing  One-Hour Briefing

There has been a lot of interest in involving the talented cadre of in-house counsel into the pro bono volunteering world, and in recent years, tremendous momentum has been gathering.  In the spirit of the upcoming 7th Annual National Pro Bono Week, please join this one-hour briefing to learn more about the art of making the match.    Topics to be addressed in this free briefing include:  The experience of in-house ...

Microsoft v. Motorola: Royalty Rates for Standard Essential Patents

One-Hour Briefing  One-Hour Briefing

In July 2015, the Ninth Circuit decided the Microsoft v. Motorola case relating to the method of calculating royalty rates for standard essential patents, the procedural tools available to a standards adopters to challenge the royalty rates being offered by a standard, and the role of the Georgia Pacific factors in evaluating rates for standards essential patents, among other topics.  This briefing will share with practitioners what they ...

Ethical Issues in Working with Pro Bono Clients (Free)

One-Hour Briefing  One-Hour Briefing

Pro Bono clients are like any other clients in many ways.  But some Pro Bono clients present ethical issues for attorneys that are often different than presented by fee-paying or contingent fee clients.  Lawyers sometimes face difficult questions about defining who the client is, communication with clients, clients with diminished capacity, conflicts with fee-paying clients, and many others.  Representation of nonprofit organizations ...

ACA's Cadillac Tax: Impact and Outlook

One-Hour Briefing  One-Hour Briefing

A key provision of the Affordable Care Act is the so-called "Cadillac Tax," a 40% nondeductible excise tax on the value of employer-provided health insurance coverage exceeding specified dollar limits.  Controversial when first enacted, the tax has only grown in controversy since enactment.  Even though the tax will not be levied until 2018, it is already having an impact across the country on employer-sponsored health benefits.  Please ...

Financially Distressed Companies and Introduction to Bankruptcy Law

One-Hour Briefing  One-Hour Briefing

In order to survive, a company in financial distress must approach its business and capital structure differently than a financially sound company.  The response of a company to its deteriorating financial condition will almost certainly affect, perhaps in material ways, a company’s key constituents.  From the distressed company’s perspective, early detection, immediate strategic planning and timely execution on a responsive ...

Supplemental Unemployment Benefits: Practical Application, Implementation and Administration

One-Hour Briefing  One-Hour Briefing

After careful consideration, your organization has decided to carry out a reduction in force. A big question remains: How do you determine the amount of separation benefits and balance the need to reduce costs with the commitment to support separated employees? You may have heard of a Supplemental Unemployment Benefits (SUB) Plan; but how does it really work and what does it actually take to put the plan in action?  Please join Elizabeth Corley, ...

When Good Intentions Go Awry: An Introduction to Behavioral Ethics in a Legal Context

One-Hour Briefing  One-Hour Briefing

Ethics discussions often focus narrowly on the “bad apples” who deliberately choose to evade the rules of the profession. But as decades of empirical research demonstrate, unethical behavior frequently results from a broader set of variables that can cause even well-intentioned lawyers to act contrary to their own principles. Recently dubbed “Behavioral Legal Ethics,” this area of study draws lessons from behavioral science ...

Mental Stability in the Workplace: Assessments, Accommodations and Responses to Threats and Violence

One-Hour Briefing  One-Hour Briefing

Threats of physical harm in the workplace may arise in a variety of ways, none benign.  They range from bullying behavior to blatant homicidal and suicidal statements.   Typically, employers must contend with a threatening and aggressive employee while under considerable pressure to take action quickly.  Employers must safeguard their employees and workplace without under- or over-reacting, or running afoul of laws that protect ...

Accounting Materiality: In Fraud or in Fair Weather

One-Hour Briefing  One-Hour Briefing

When is an error in a financial statement considered material?  Tune in to hear from distinct perspectives – from the viewpoint of the accountant, the attorney, and former SEC regulator - on what “materiality” in financial statements means in both good and troubled times.  FTI Consulting, Inc. Senior Managing Directors, Matthew B. Greenblatt and Jason S. Flemmons, and Baker& Hostetler LLP White Collar Defense and Corporate ...

Basics of Export Controls 2015

One-Hour Briefing  One-Hour Briefing

Save the date!  Details to follow.

Second Annual Form 10-K Tune-Up

One-Hour Briefing  One-Hour Briefing

As you draft your annual report on Form 10-K it is always a challenge to be sure that you deal effectively with new and emerging issues and the ever-evolving focus areas of the SEC.  Join our workshop leaders Carol A. Stacey and George M. Wilson, both Directors at PLI’s SEC Institute Division, as they review the key issues to address in this year’s Form 10-K.  Topics addressed will include:  SEC staff focus areas ...

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