Monthly Archives: September 2018

What’s New for September

We add content to PLI PLUS every month to ensure our subscribers have access to the most up-to-date and relevant secondary source legal documents. Renowned legal experts regularly update our acclaimed Treatises, Course Handbooks, Answer Books, Transcripts and Forms to reflect recent changes and developments in the law.

Click here to see what we added in September!

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.