Category Archives: New Edition!

Book Update: Pharmaceutical Compliance and Enforcement Answer Book  

Pharmaceutical Compliance and Enforcement Answer Book (Eleventh Edition) provides readers with a solid framework for understanding and navigating the rigorous—and regularly overlapping—requirements imposed by varying governmental authorities and private parties upon the pharmaceutical industry. This treatise analyzes the basic foundations of pharmaceutical industry regulation through the lens of current legal, regulatory, and compliance developments. 

Highlights of the recent update include:  

  • A new chapter 13, Radical Transparency and Product Liability Exposure—The New Frontier, examining the FDA’s new policy of releasing all Complete Response Letters as they’re issued to drug sponsors, as well as the implications of this policy on product liability claims. 
  • Updated guidance in Chapter 2, FDA Enforcement—Facility Inspections on best practices for handling FDA inspections, including a sample corporate policy to ensure compliance with recordkeeping and documentation requirements. 
  • Amendments to Chapter 5, Federal and State Regulation and Enforcement of Pharmaceutical Manufacturers’ Advertising and Promotional Activity, reflecting the latest rules, guidance, and enforcement actions regarding pharmaceutical manufacturer advertising and promotional activity. 
  • Revisions to include the current enforcement environment related to off-label promotion (Chapter 6), including further discussion of the FDA’s final guidance on scientific information on unapproved uses of off-label promotion in relation to approved/cleared medical products (Chapter 7). 
  • Inclusion of a circuit split regarding interpretation of language in the Patent Protection and Affordable Care Act which may significantly impact False Claims Act damages in AKS-based cases (Chapter 14). 

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Copyright Law: A Practitioner’s Guide (Second Edition) 

Copyright Law: A Practitioner’s Guide (Second Edition) serves as a crucial reference guide for general practitioners, in-house counsel, and any other professionals who may require quick and effective answers to copyright questions. This treatise provides a current analysis of court cases and a methodical approach to copyright law. 

Highlights of the new edition include:  

  • Clarification of the copyrightability of AI-generated content pursuant to the Copyright Office’s 2025 report (Section 2:7.5) 
  • Examination of three separate district court rulings in Delaware and California regarding an AI developer’s use of copyrighted material and whether it was deemed fair use (Section 8:1) 
  • A ruling by the Second Circuit on a nonprofit organization’s distribution of books online and its eschewal of fair use (Section 8:4.2[A]) 
  • A finding by a California district court that the sale of a social media platform’s public data and its preemption by the Copyright Act (Section 11:3.4[C]) 
  • Coverage of the “simple measures” test by the Fifth Circuit in a case upholding the liability of an internet service provider in failing to halt infringement (Section 11:8.3[B]) 

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New Edition! Net Leases and Sale-Leasebacks

Net Leases and Sale-Leasebacks: A Guide to Legal, Tax and Accounting Strategies (2025 Edition) covers all aspects of the ownership, financing, documentation, taxation, and accounting for net leases with a focus on those areas where the treatment of net leases differs from the treatment of other forms of real estate investment. Given their unique characteristics, net leases may be regarded as belonging to their own asset class, and the real estate professionals practicing in this field need to be familiar with the distinct issues that may arise.

The new edition includes the following updates:

  • Chapter 2, The Lease, New section 2:2.5 discusses the tenant’s right of rescission, covering material breach by the landlord (including independent versus dependent covenants; constructive eviction; and landlord’s breach of the covenant to repair); mistake; and fraud.
  • Chapter 5, Tax Considerations, has been further expanded in several areas:
    • Subsection 5:1.3[A] covers tenant purchase options and SILO (sale-in, lease-out) transactions.
    • Subsection 5:3.9[A] discusses whether a section 467 loan can satisfy the requirements for qualified real property business indebtedness.
    • Subsection 5:7.3[C][1] discusses the exemption for transfer of a leasehold interest in Pennsylvania.
    • Subsection 5:9.1[D] expands the discussion of choice of entity for the owner-landlord.
    • Subsection 5:10.2[E] discusses layered allocations versus target allocations for partnerships.
    • Subsection 5:10.6 explores the difference in tax consequences between a sale and a redemption of a partnership interest.
    • Subsection 5:15 discusses solar federal tax credits in depth.

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PLI PLUS subscribers can access this title through their subscription. 

New Edition! International Tax & Estate Planning: A Practical Guide for Multinational Investors (Fourth Edition)

PLI Press is proud to announce the publication of the fourth edition of International Tax & Estate Planning.

This book deals with the management and disposition of multinational estates. It presents a practical approach to maximizing assets, minimizing taxes and risks, and avoiding legal disputes. Featuring helpful charts and checklists, it offers strategies for drafting wills and trust documents that secure clients’ interests. It also provides tips on how to prepare estate planning vehicles and individualized testamentary plans, protect investments against government expropriation, calculate tax credits and owed taxes, and navigate federal reporting requirements and relevant forms.

Some of the recent developments discussed in this new edition include:

  • Domicile: Clarification of the legal construct of “domicile” and whether it is determined based on “permanency” or “an intent to return indefinitely” (see section 1:3.1).
  • Gift Tax: Updated information on the requirements a nonresident alien must meet to qualify for the annual gift tax exclusion (see section 3:6).
  • U.S. Federal Reporting Requirements: Exploration of the reasons why increased regulatory attention has been given to the conflict between an individual’s right to privacy and the government’s need to access financial information for tax and other fiscal purposes (see NEW Chapter 5).
  • Trusts: Discussion of how to navigate the complexities of conflicting intersecting principles in civil and common law (see FULLY REWRITTEN Chapter 6).
  • Cryptocurrency and Digital Assets in Estate Planning:  Specification of the additional details that must be included in a digital asset provision to ensure that these assets may be accessed (see section 7:8.2).

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New Editions! SEC Compliance and Disclosure Series

PLI Press is proud to announce the publication of new editions to all three books in the SEC Compliance and Disclosure Series – Master the 8-K, Master the 10-K and 10-Q, and Master the Proxy Statement.

These step-by-step guides deliver clear explanations, comprehensive information, and essential practice tips to implement or refine corporate disclosure controls and procedures to ensure accurate and timely filings. Master the 8-K offers updated direction on filing the SEC’s Current Report on Form 8-K. Master the 10-K and 10-Q gives instructions and analysis to ensure accurate and timely filings. Master the Proxy Statement advises companies on year-end disclosures and preparing proxy materials. The series includes sample language, detailed appendices, key regulations, and related forms and checklists.

Some of the highlights from the recently published editions include:

Master the 8-K:

  • The latest guidance on the instances in which an employment relationship or transaction and any resulting compensation involving an executive officer need not be disclosed (see Appendix 7, Section 5(a)(iii))
  • Added information on purchases of equity securities by the issuer and affiliated purchasers (see Appendix 2, Section 26)
  • A new appendix dedicated to Regulation S-K, Item 106 Cybersecurity (see Appendix 11)

Master the 10-K and 10-Q:

  • Additional explanation of the information to be provided on the cover page of an Annual Report on Form 10-K including a new section on “clawback” disclosures (see Section 1:11)
  • Notification on updates to the disclosures required by Item 408(d) of Regulation S-K (see Section 3:8.4)
  • Communication about items required to be disclosed under Item 703 of Regulation S-K (see Section 8:3.6)  

Master the Proxy Statement:

Order print copies of the new editions of Master the 8-K, Master the 10-K and 10-Q, and Master the Proxy Statement today.  The books of the series can be purchased individually as standalone guides or purchase all three for the full series.

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New Edition! Anti-Money Laundering Deskbook (Second Edition)

PLI Press is proud to announce the publication of the second edition of Anti-Money Laundering Deskbook.

This book is a comprehensive and accessible guide to the money laundering and anti-money laundering (“AML”) legal regimes and compliance requirements for U.S. financial institutions. Designed as a practical resource to serve a wide audience of professionals, the deskbook integrates real-world enforcement cases to illuminate complex concepts in a practical way and demonstrates how those cases have shaped AML policies and practices. It also provides insight into the intersection between the two legal regimes, offering a full view of the legal and regulatory landscape.

Some of the recent developments reflected in this new edition include:

  • Criminal money laundering laws: Explanation of the extraterritorial application of the criminal money laundering laws (see Section 2:3.4).
  • AML laws and regulations: Discussion of the AML Act and the expansion of U.S. AML laws and regulations (see Section 4:1.3).
  • AML compliance and enforcement: Coverage of new developments with respect to AML compliance in the digital assets industry and the role of state regulators in AML compliance and enforcement (see Section 4:2.5 and Chapter 8).
  • Money laundering risks: Identification and analysis of the money laundering risks of new financial technologies (see Chapter 12).

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PLI PLUS subscribers can access this title through their subscription.

New Edition! Pharmaceutical and Biotech Patent Law (2023)

PLI Press is proud to announce the publication of the new edition of Pharmaceutical and Biotech Patent Law.

This book provides the legal, scientific, and technical information needed to help clients obtain, defend, and challenge patents in these important business areas. It shows readers how to craft problem-free patent applications and includes detailed checklists that help resolve tricky patent issues in the complex pharmaceutical and biotech fields. It is regularly updated to reflect Federal Circuit rulings and other significant court decisions.

Some of the recent developments reflected in this new edition include:

  • Inter Partes Review: Coverage of the PTO guidance for discretionary denials which clarifies when institutions will not be denied under Fintiv (see Section 1:5.3).
  • Patentability of Stereoisomers and New Salts: Discussion of the Federal Circuit’s decision in Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp. regarding whether Mylan Pharmaceuticals had failed to show that the claims of U.S. Patent No. 7,326,708 were either anticipated or rendered obvious by the asserted prior art (see Sections 7:2.4[A][2] and 7:2.6[C][1]).
  • Cell and Gene Therapy Products: New chapter exploring the patent landscape for cell and gene therapy products and the current disputes related to these products (see Chapter 15).
  • ITC Litigation: New chapter providing recent trends and practice tips on ITC Litigation (see Chapter 16).

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PLI PLUS subscribers can access this title through their subscription.

New Edition! Net Leases and Sale-Leasebacks: A Guide to Legal, Tax and Accounting Strategies (2023 Edition)

PLI Press is proud to announce the publication of the new edition of Net Leases and Sale-Leasebacks: A Guide to Legal, Tax and Accounting Strategies.

This pragmatic guide offers invaluable strategies on how to best approach the most common ownership, financing, documentation, taxation, and accounting issues associated with net leases and sale-leaseback transactions.  It provides example lease documents and in-depth coverage around net leases — along with the legal and structuring issues that impact how they are taxed. Author Ken Miller packs the pages with practical guidance and insight gleaned from his storied career helping clients close more than $7 billion of U.S. commercial real estate transactions, primarily involving net-leased properties.

Some of the highlights from the new edition include:

  • Chapter 2: New sections on legal doctrines relevant to net leases, including landlord liability for injuries on the premises (see §2:2.1), tenant estoppel certificates (see §2:2.2), implied covenants to provide tenant with possession (see §2:2.3), and liability of successor landlord for breaches by former landlord (see §2:2.4).
  • Chapter 5:  
    • New discussion of section 467 rental agreement accrual, including assignment of a tenant’s interest in a section 467 rental agreement (see §5:3.8) and early termination of such an agreement (see §5:3.9).
    • New sections on self-employment taxes (see §5:12) and state taxes (§5:13), with a focus on franchise, excise, and similar taxes in Tennessee, Texas, and California.
  • Chapter 6:  New discussion of I.R.C. section 4975 and the “look through” rule as it applies to investments made by benefit plan investors (see §6:1).
  • NEW Appendix F: Section 467 Rental Agreement Accrual Table.
  • Appendix D and Appendix E have also been updated.

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New Edition! Federal Bail and Detention Handbook 2023

PLI Press is proud to announce the publication of the new edition of the Federal Bail and Detention Handbook.

This helpful resource provides on-point answers to all aspects of federal bail and detention law — especially those involving critical provisions of the Bail Reform Act of 1984. Through discussions told from grounded judicial perspectives, the book presents helpful practice pointers when confronting common Bail Reform Act problems. It also showcases an extensive series of forms, sample orders, and sample motions that defense counsel and assistant U.S. attorneys can reference.

Some of the recent developments reflected in this new edition include:

  • Weight of Evidence: Coverage of the United States v. Zhang case in which the Second Circuit ruled on whether the Bail Reform Act provides guidance on the relative weight the court should give the various section 3142(g) factors in deciding questions of release and detention (see Section 4:3).
  • Least Restrictive Possible Conditions: An update on a case arising from the January 6, 2021, invasion of the Capitol about whether the D.C. Circuit Court upheld or reversed the district court’s denial of the defendant’s request to travel abroad for three weeks for an educational opportunity (see Section 5:3).
  • Conditions in Every Bond: New discussion of a Third Circuit ruling regarding whether the “no crimes while on bond” condition prohibits the possession or use of marijuana in a state where marijuana is legal and in a situation in which the defendant has a “medical marijuana” authorization from a physician for its use (see Section 5:4).
  • Detention or Release Pending Competency Examination: New information about a Ninth Circuit case which considered whether a lack of an available bed at an appropriate facility relieves the Attorney General of the duty to attempt to rehabilitate the defendant within a brief period (see Section 14:10).

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New Edition! Healthcare Employment Practice: Policy, Law and Procedure (2023 Edition)

PLI Press is proud to announce the publication of the new edition of Healthcare Employment Practice: Policy, Law and Procedure.

This guidebook presents clearly-written, concise insights into how hospital management teams, healthcare human resources professionals, and the legal practitioners who advise them can navigate the ever-changing regulatory landscape around employment in the healthcare industry.

The treatise’s authors, James T. O’Reilly, Director of the Concentration in Health Services Management at the UC College of Medicine, and Mary Ellen Keegan, former in-house counsel for GE’s Aviation Division who has since negotiated favorably for MDs in disputes with insurance companies and healthcare organizations, offer actionable practices gleaned from their experiences working with physicians and public health regulatory issues.

Featuring sample contractual clauses, this resource discusses how doctors, stakeholders, and their lawyers can leverage astute planning and careful drafting to overcome emerging employment and transactional issues. In addition, the authors include tailored discussions on regulatory and transactional issues unique to physicians, registered nurses, and non-credentialed healthcare employees.

Healthcare Employment Practice includes:

  • Step-by-step, term-by-term guidance on physician employment contracts, with an emphasis on the problems presented by restrictive covenants, and a full sample Physician Employment Agreement (see Chapter 9, Chapter 10, and Appendix B);
  • A fifty-state survey of noncompete statutes and selected case law (see Appendix A – fully updated for 2023);
  • Labor and employment law as it affects healthcare industry employees in the areas of Collective Bargaining and Overtime Pay (see Chapter 14 and Chapter 19), Strikes and Lockouts (see Chapter 17), Safety Rules (see Chapter 20), and Conflict Resolution (see Chapter 21);
  • Issues presented by telemedicine (see Chapter 27);
  • Stark and anti-kickback law compliance (see Chapter 26);
  • Employment discrimination in healthcare: physician whistleblower, discrimi­nation, harassment, and retaliation claims (see Chapter 22).

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