Category Archives: PLI Press

New Edition! Medical Devices Law and Regulation Answer Book (2019 Edition)

PLI recently published the 2018 edition of Medical Devices Law and Regulation Answer Book, in which more than thirty contributors from various law and consulting firms share their expertise regarding the wide range of topics encountered in this heavily regulated field.

This book provides in-depth coverage of individual FDA programs that govern everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations and more. Presented in a question-and-answer format, this guide also discusses related topics that have a marked impact on the medical devices industry, such as intellectual property, product liability, and reimbursement.

Medical Devices Law and Regulation Answer Book is designed to distill the essential elements of this complex regulatory environment and provide a practical guide to the complexities of FDA regulation of medical devices. It is a practical, in-depth reference for all lawyers, consultants, and companies operating in the medical devices sector, as well as all companies contemplating entertering it .

This updated answer book is available on PLI PLUS, our research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

Treatise Update! Financial Product Fundamentals: Law, Business, Compliance

PLI recently updated Financial Product Fundamentals: Law, Business, Compliance (Second Edition).

To provide attorneys, compliance personnel, and business professionals with legal, regulatory, and procedural guidance regarding the various financial products, Clifford E. Kirsch has edited Financial
Product Fundamentals, which compiles his expertise as a noted practitioner in the areas of securities regulation and compliance, together with valuable contributions from other distinguished authorities in these practice areas.

Highlights of the latest version include:

  • Chapter 2: Limited Offerings and Private Placements. Updated to reflect recent amendments to Rule 504 under Regulation D that increase the aggregate amount of securities that may be offered and sold in any twelve-month period, and disqualify certain bad actors from relying on Rule 504.
  •  Chapter 12, International Investment Funds. Commodity Futures Trading Commission (CFTC) registration analysis for commodity pool operators and commodity trading advisors (CTAs), as
    well as the exemptions from registration as a CTA pursuant to Rules 4.14(a)(4), 4.14(a)(5), and 4.14(a)(8).
  • Chapter 17, Exchange-Traded Funds. New discussions covering ETF distribution and associated fees, Authorized Participants and Authorized Participant Agreements, and marketing and advertising considerations for ETFs. Discussion updated to include recent regulatory developments regarding listing standards, reporting requirements and risk disclosures, and the Liquidity Rule’s application to In-Kind ETFs.
  • Chapter 19, A Primer on Derivative Contracts and Their
    Regulation. Updated discussion follows the actions of the CFTC and SEC in addressing the many Dodd-Frank issues under their respective jurisdictions to regulate the swaps marketplace.
  • Chapter 24, Exchange-Traded Notes and Similar Structured
    Notes. New discussion covers issues with respect to other types of structured notes that are not listed on securities exchanges.
  • New Chapter 27, Interval Funds. New discussion places interval funds in their regulatory framework, and covers issues associated with their operation and distribution, as well as the investment strategies utilized by these funds.

This essential title is available on PLI PLUS, our online research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

Treatise Update! Langer on Practical International Tax Planning

PLI recently published an update to Langer on Practical International Tax Planning.

This treatise provides current knowledge and expert advice you need to help clients capitalize on ripe tax havens and financial centers.

The latest update includes several newly added sections covering the following topics:

  • The 2017 Tax Act. This new section outlines numerous changes made by the 2017 Tax Cuts and Jobs Act, including changes to the capital gains rate, deduction for state and local property and income taxes, dividends-received deduction, net operating losses, and like-kind exchanges.
  • Unemployment Compensation Paid After Leaving the United States.In what it said was a case of first impression for it, the Tax Court addressed whether a nonresident alien (Canadian) who had worked in the United States was exempt under treaty from taxation on unemployment compensation she received after having gone back to Canada.
  • Expatriating Corporations—Excise Tax. Updates provide the latest on how the 2017 Tax act affect the excise tax, which can apply to certain “disqualified” individuals if a corporation expatriates and gain on any stock in the expatriated corporation is recognized by any shareholder with respect to the expatriation transaction.
  • Charitable Distributions. This discussion covers newly modified procedures for how foundations may make a “good faith determination” that a foreign grantee is a “qualifying public charity.”
  • Payments to Related “Captive Insurance Companies”. Coverage of a 2017 Tax Court case examines the Service’s denial of a taxpayers’ claimed deductions under section 162 for amounts paid by their pass-through entities to a related captive insurance company.
  • Deemed Repatriation. This new section discusses how, under the 2017 Tax Act, U.S. shareholders owning at least 10% of a foreign subsidiary generally must include in income, for the subsidiary’s last tax year beginning before 2018, the shareholder’s pro rata share of the accumulated post-1986 historical E&P of the foreign subsidiary as of the “measurement date,” to the extent such E&P has not been previously subject to U.S. tax.

The updated treatise is available on PLI PLUS, our research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

PLI Current: The Journal of PLI Press

We are pleased to announce that the Summer 2018 issue of PLI Current: The Journal of PLI PLUS  is available on PLI PLUS! Each issue of PLI Current features original articles that cover new and emerging developments impacting the law and the legal profession. In every issue you’ll find expert insights, commentary, and analysis from leading practitioners, including PLI authors and faculty members.

Articles in this Summer 2018 issue include:

The Summer 2018 issue also features articles on data security and the CLOUD Act; preparing for depositions and motions in limine; modernizing communications safe harbors for issuers of securities; the impact of Trump’s tax cuts on profits interests as executive compensation; and more.

PLI Current  is available through your PLI PLUS subscription.

Not a PLI PLUS subscriber? Click here to sign up for a FREE digital version of PLI Current. The journal is also available here for purchase in print.

New Edition! Financial Institutions Answer Book: Law, Governance, Compliance (2018 Edition)

PLI recently published the 2018 edition of Financial Institutions Answer Book, which provides a comprehensive overview of the complex federal requirements regulating financial institutions in the United States in an easily accessible Q&A format.

Every aspect of a financial institution life cycle is covered, from understanding the differences in regulation based on what type of charter is chosen, through ongoing capital and deposit activities requirements and major changes in corporate control, to the cessation of entity activity through merger, acquisition, or entity failure.

Financial Institutions Answer Book describes the requirements under each type of charter for the major areas of financial institution activity, such as:

Reflecting the increased federal concern with fraud, money laundering, and protecting the federal taxpayer from bank defaults, individual chapters are devoted to describing in detail the federal enforcement agencies and their powers, anti-money laundering and other fraud issues, the required examinations and audit process, and recent regulatory approaches to problem banks and failure.

Published in a handy softcover volume, Financial Institutions Answer Book is a source for quick, concise answers for lawyers and other legal professionals, as well as financial institution managers, officers, directors, and anyone else who would like a comprehensive understanding of the legal framework regulating banks and other financial institutions.

This new answer book is available on PLI PLUS, our research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

Deskbook on Internal Investigations, Corporate Compliance, and White Collar Issues

PLI recently updated Deskbook on Internal Investigations, Corporate Compliance, and White Collar Issues.

This treatise provides practical guidance on how to carry out internal investigations to identify and remediate legal problems, protect the rights of employees when they’re subject to investigation or prosecution, and cooperate with government investigators in ways that help reduce legal and financial damage if wrongdoing is proved.

The latest update includes coverage of the following topics:

  • Major ongoing antitrust investigations: A new section has been added discussing the Packaged Seafood Investigation into price-fixing of packaged seafood between the brands Chicken of the Sea and Bumble Bee, and its consequences including abandonment of a proposed merger, cooperation by the parent company of Chicken of the Sea in the investigation, agreement by Bumble Bee Foods to plead guilty to a criminal charge, and guilty pleas to charges of conspiracy by several corporate executives.
  • The most recent civil and criminal FCPA enforcement actions against companies and individuals: An updated discussion of The Foreign Corrupt Practices Act and the International Conventions on Bribery explores the DOJ’s revised Corporate Enforcement Policy, making permanent many of the core elements of the Obama administration’s Pilot Program, which has guided the DOJ’s FCPA enforcement decisions over the past year and a half. New to the policy is a presumption in favor of non-prosecution when companies self-report, cooperate, and remediate.
  • Deferred Prosecution Agreements (DPAs): the updates reflect the most recent (DPAs), while noting the decrease in number of such DPAs over the last few years.

The updated treatise is available on PLI PLUS, our research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

PLI PLUS New Content Added in 2018

PLI PLUS, PLI’s online research database, provides unlimited access to PLI Press Treatises, Course Handbooks, Answer Books, Journals, in addition to Legal Forms and Program Transcripts. To reflect recent changes and the latest in legal developments, PLI PLUS is updated continuously with supplements and new editions as well as completely new titles.

Here is a list of new PLI titles added from 2015 through 2018:

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Questions? Email PLUS@pli.edu or call 877.900.5291.

New Edition! Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition)

 

PLI recently published the 2018 edition of Pharmaceutical Compliance and Enforcement Answer Book, which provides a comprehensive overview of the complex regulatory issues faced by the different participants in the pharmaceutical industry.

This resource gives clear, expert answers to questions on topics such as:

Filled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.

This new answer book is available on PLI PLUS, our research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

Treatise Update! Friedman on Leases

PLI recently updated Friedman on Leases (Sixth Edition). This acclaimed treatise clarifies and analyzes the full range of lease provisions and conceivable landlord-tenant situations to give you unsurpassed practical instruction on how to negotiate and draft airtight agreements that protect your clients’ rights and minimize their liability exposure.

This definitive work continues to deliver not only the foundational knowledge required by novice practitioners, but also analysis of and insight into the most current and relevant developments facing
seasoned practitioners in the commercial real estate field.

Highlights of this Release #3 include the following:

    • Disclaimer of Waiver by Landlord: Updated discussion examines
      whether a nonwaiver provision may be waived.
    • Security Deposit Clause: New samples of a lease provision that requires
      tenant to deposit cash as security; a lease provision that requires
      tenant to deposit a letter of credit as security; a lease provision that permits
      tenant to deposit either cash or a letter of credit as security; a lease
      provision that permits the security deposit to be reduced if certain conditions
      are satisfied; and a form of a letter of credit to be attached as an
      exhibit to a commercial lease.
    • Option to Cancel Lease—Sample Provisions: New samples of negotiated
      provisions granting tenant the one-time right to cancel.
    • Stipulations: Instead of a stipulation that permits tenant to remove
      its installations, an alternative approach is for the parties to define in the
      lease what constitutes “Tenant’s Property,” and that the tenant has the
      right (and/or the obligation) to remove its property. A new sample provision
      of this type is provided.

This essential title is available on PLI PLUS, our online research database.  If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.