Foley Hoag lawyers are frequent contributors to legal and industry publications, and offer insightful analysis in our own publications ― many of which are available in downloadable eBook format here at foleyhoag.com.
Foley Hoag's eBook Library offers you valuable information on today's most important issues, with titles including Follow-on Biologics and Patent Reform, Patenting, and Five Common Employment Law Hazards for Start-Ups.
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Date |
Authors |
Type |
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| Rule 502: Does It Deliver on Its Promise? |
Jul 16, 2010 |
Ara Beth Gershengorn, Lisa C. Wood |
General |
Download |
Antitrust - Summer 2010
SUMMARY
A year and a half has passed since Congress sought to make document productions and associated pre-production privilege review less costly and less burdensome with the passage of Federal Rule of Evidence 502. In this column, we examine the new rule, describe what parties can do to maximize their protection under the rule, and highlight the potential risks the rule has left unaddressed.
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| Doing Business in the United States |
Jun 3, 2010 |
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eBook |
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A Guide to U.S. Law for Non-U.S. Businesses
SUMMARY
This guide is intended to provide foreign businesspeople with an introduction to the basic kinds of laws and regulations that affect the conduct of business in the United States. The level of detail is varied, reflecting the nature of the legal areas discussed. For example, environmental law and taxation are subjects of detailed and technical regulation, while labor relations are governed as much by custom and practice as by direct regulation. The discussion under each heading is intended to provide only general guidance and is not an exhaustive description of all provisions of federal, state and local law with which a non-U.S. business operating in the U.S. might be required to comply. The laws whose effects are described in this guide are subject to interpretation by courts, may be affected or preempted by federal statutes or regulations, and may themselves be amended or repealed. Particular businesses or industries may also be subject to legal requirements not referred to in this guide. For this reason, you should not rely solely upon this guide when planning the details of a specific transaction or undertaking. Instead, the pertinent details of any transaction or business should be reviewed thoroughly by qualified legal counsel. This guide is intended to outline issues that you may need to address with your legal counsel.
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| MassChallenge - Incorporating Your Startup |
May 26, 2010 |
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General |
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SUMMARY
MassChallenge is a recently created partnership designed to accelerate the development and success of high-growth, high-impact new businesses and to stimulate job creation across the Commonwealth and beyond. Foley Hoag LLP is proud to be a sponsor and supporter of this initiative. MassChallenge has launched a series of initiatives aimed at recruiting and cultivating entrepreneurs who are interested in entering the competition. A training seminar hosted on May 25 titled "Incorporating Your Startup" was presented by Foley Hoag lawyers Gil Arie, Mark Haddad, David Pierson and Paul Sweeney. The course covered the basics of incorporation from choosing a form of legal entity and deciding when to incorporate. Interested entrants can download the full presentation here.
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| Implementing a Corporate Free, Prior, and Informed Consent Policy: Benefits and Challenges |
May 4, 2010 |
Amy K. Lehr, Gare A. Smith |
eBook |
Download |
May 2010
SUMMARY
Executive Summary
This report explores the benefits that Talisman Energy Inc. (“Talisman”) might derive and the challenges it might encounter if it were to adopt a policy to secure the free, prior, and informed consent (“FPIC”) of indigenous peoples potentially impacted by its global operations. Talisman commissioned this report at the request of two responsible investors, Bâtirente and Regroupement pour la responsabilité sociale des entreprises (“RRSE”). The World Resources Institute (“WRI”), a think tank and thought leader on FPIC, was asked to provide a third party commentary on it. The scope of the report, as agreed by Talisman, the responsible investors, and WRI, includes the legal history of FPIC, the opportunities and challenges attendant to a FPIC policy, FPIC best practices, and guidance on FPIC policy language and implementation guidelines.
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| Personalized Diagnostics: The Struggle for Position |
Apr 29, 2010 |
Bruce Quinn, M.D., Ph.D. |
General |
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Personalized Medicine - May 2010, Volume 7, Number 3
SUMMARY
For several major cancers, drug selection already pivots on biomarker results (e.g., trastuzumab for breast cancer, and gefitinib and erlotinib for lung cancer). Fast-paced advances in genomic and proteomic laboratory technologies could enable the widespread use of molecular testing before therapy selection in any field of medicine. This article describes two potentially large obstructions to such innovation. First, laboratory tests have traditionally been commodities with low prices, prices that matched the resources required to operate the laboratory technology itself.
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| Five Common Employment Law Hazards for Start-Ups |
Apr 29, 2010 |
Michael L. Rosen |
eBook |
Download |
SUMMARY
Contents
1. Exposure to Liability in the Hiring Process
2. Failure to Adequately Document Terms and Conditions of Employment
3. Misclassification Issues - Employee or Independent Contractor - Exempt or Non-exempt
4. Failure to Comply with Wage Payment Laws
5. Inadequate Protection of Intellectual Property
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| Obligations of Insurer and Policyholder |
Apr 6, 2010 |
Martin C. Pentz, Jeremy A. M. Evans |
eBook |
Download |
Foley Hoag LLP eBook Series
SUMMARY
Introduction
The insurance relationship is primarily one of contract, with the insurance policy as the principal source of the parties’ obligations. As with other types of insurance, the duties of the parties—and the consequences of breaching those duties—are affected by government regulation, primarily in the form of state statutes addressing insurer conduct. Another source of law affecting insurance obligations is the judiciary. As liability insurance disputes became a staple of the courts’ civil dockets during the second half of the twentieth century, recurring issues generated a significant body of common law. Nevertheless, in any study of the obligations of insurer and insured under liability coverages, there is no avoiding the oft-used insurer admonition, “Read Your Policy.”
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| Commercializing Stem Cell-Based Therapies: Meeting NIH and FDA Requirements |
Sep 9, 2009 |
Kalah Auchincloss |
eBook |
Download |
A Foley Hoag eBook - September 2009
SUMMARY
In March, President Obama signed an executive order lifting the Bush Administration restrictions on federal funding for human embryonic stem cell (HE S) research. The possibility of new federal funding opportunities, in combination with more than a decade of scientific advances in both embryonic and adult stem cell research, signal that stem cell-based therapies (“SCBT”) could soon be available for patients in a clinical setting. For those wishing to commercialize such therapies, it will be important to ascertain how the U.S. Food and Drug Administration (“FDA ”), which has regulatory authority over U.S. marketing of SCBT, will exercise this oversight.
This article is not intended to be an exhaustive dissertation on all laws and regulations pertaining to stem cell research, embryonic or otherwise.1 Rather, it discusses the controversial history of federal funding for stem cell research, and then focuses on regulations and guidelines likely to govern FDA approval of clinical applications of SCBT. It also discusses some of the recent recommendations included in the International Society for Stem Cell Research Guidelines in the context of U.S. application of those recommendations. (continues...)
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| Massachusetts and Federal Statutory Limitations on Liability for Charitable Organizations and their Directors or Trustees, Employees and Volunteers |
Jul 31, 2009 |
Shirin Philipp, John M. Stevens, Jr., |
General |
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Nonprofit Summary Memorandum
SUMMARYIn Massachusetts, charitable corporations, trusts and associations are not liable for more than $20,000 in damages for injuries (“torts”) caused by the organization while engaging in charitable activities. An organization will be categorized as charitable if “the dominant purpose of its work is for the public good.” Its activities will be characterized as charitable if they contribute directly to its charitable purposes. (more...)
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| Five Key Steps to Developing an Information Security Program |
Jul 17, 2009 |
Gabriel M. Helmer |
eBook |
Download |
SUMMARY
Information security — the discipline of protecting information found in paper documents, electronic files and emails — has become increasingly important in business. As reports of identity theft, data breaches and cybercrime have become more common, government has begun to call on businesses, both large and small, to take on new responsibilities for protecting sensitive information.
Responding to the rising tide of damaging security incidents, the federal government and the majority of states have enacted laws and regulations requiring individuals and companies to adopt comprehensive information security programs to protect sensitive information. (more...)
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| The Alphabet Soup of the Financial System Bailout |
Jun 24, 2009 |
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Download |
SUMMARY
A glossary of programs administered by the Treasury, the FDIC and the Federal Reserve.
Excerpt:
TARP, TALF, TGLP… Help!!! Ever since Congress passed the Emergency Economic Stabilization Act on October 3, 2008, the Secretary of the Treasury, the Federal Deposit Insurance Corporation (FDIC) and the Federal Reserve have been working at a feverish pace to come up with solutions to the unprecedented crisis in the financial markets continues...
Originally published in
Bank Accounting & Finance.
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| Trade Secrets: A Guidebook for Technical and Business Professionals Involved in Legally Protecting Products, Technologies and Services |
May 1, 2009 |
Vickie L. Henry |
eBook |
Download |
Foley Hoag eBook
SUMMARY
Trade secrets can be a valuable component of an intellectual property (IP) portfolio, whether as a complement to patents or as an alternative. Companies benefit from an IP portfolio that matches the unique benefits of trade secrets and patents to the types of information they seek to protect. Trade secret protection can be available immediately, without going through a government agent, whereas a patent is available only after an application to and approval by the government. And unlike patents, trade secrets provide IP protection of potentially infinite duration. Trade secret protection is also available for a broad array of information for which patents are not available.
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| Medicare Authorities To Reduce Payment for Covered Items or Services |
Apr 15, 2009 |
Thomas Barker |
General |
Download |
SUMMARY
This chart shows a side-by-side comparison of Least Costly Alternatives, Inherent Reasonableness, and Functional Equivalence.
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| The Employee Free Choice Act: Understanding the Act and Protecting your Business |
Apr 2, 2009 |
Jonathan A. Keselenko |
eBook |
Download |
Foley Hoag eBook
SUMMARY
The Employee Free Choice Act is proposed federal legislation that would greatly improve union chances of winning certification elections and would increase union membership throughout the country. Businesses have identified the EFCA as a serious threat and one that has a good chance of becoming law.
At this point, no one can predict whether the EFCA will pass as proposed, whether it will pass in an amended form, or whether it will pass at all. But, regardless, union organizing activity will likely increase in coming years due to the changed political environment, and employers need to be prepared.
I hope that you find the information in this booklet helpful, and please feel free to contact me if you have any questions.
Sincerely,
Jonathan A. Keselenko Partner, Labor and Employment Department
Partner, Labor and Employment Department
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| Health Information Technology Provisions in the Recovery Act |
Apr 1, 2009 |
Brian P. Carey, Paul T. Kim |
eBook |
Download |
SUMMARY
The following is an overview of the health information technology (HIT) provisions in H.R. 1, the American Recovery and Reinvestment Act of 2009 (ARRA, or Recovery Act), which President Obama signed into law on February 17, 2009. This document reviews potential funding sources and key decision makers for HIT at the Department of Health and Human Services (HHS) and its agencies. This overview highlights the HIT incentive payments, which are the largest piece of HIT funding in the Recovery Act, how various provisions of the HIT provisions are to be implemented, when they are required or expected to happen, and who the key players will be in the process.
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| Final Pharmaceutical and Medical Device Manufacturer Conduct Regulations |
Mar 19, 2009 |
Colin J. Zick, Pat A. Cerundolo, Tad Heuer |
eBook |
Download |
Foley Hoag eBook
SUMMARY
On March 11, 2009, the Massachusetts Public Health Council promulgated final regulations (105 CMR 970.000) for the administration of Chapter 111N of the Massachusetts General Laws, which governs the marketing activities of pharmaceutical and medical device manufacturing companies. When the Legislature passed Chapter 111N in August 2008 (as Section 14 of Chapter 305 of the Acts of 2008) (the “Law”), Massachusetts joined the District of Columbia and six other states in regulating the relationships between the pharmaceutical and medical device industries and physicians. Understanding these final regulations is of significant importance to anyone involved in the Massachusetts biotechnology, health care, and drug and device sectors. The regulations apply broadly to pharmaceutical or medical device manufacturing companies (“PMDMCs”), including companies that are “directly” engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs, biologics or medical devices. In accordance with the requirements of the Law, the regulations establish a fine of $5,000 for each knowing and willful violation.
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| Compensation for Angel Group Leadership |
Mar 9, 2009 |
Peter M. Rosenblum |
General |
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SUMMARY
The organized angel group movement is maturing. As angel groups are growing in membership, portfolio size, experience, increased effort and involvement are required to manage each group.
Angel groups often start with volunteer members doing the work. Over time, some angel groups remain member-led and managed. Other groups compensate members who do additional work, sometimes on rotation, and still other groups hire professional managers, who may be full- or part-time.
Based on 2009 data, just over half of all 165 angel groups that belong to the Angel Capital Association are led by their member angels and the remainder are led by non-affiliated professional management.
When angel groups talk about their approach to management, some groups feel very strongly about having non-member professional managers. In other groups—especially where there are individuals willing and able to invest a lot of time—members share the work, sometimes taking turns and sometimes relying on a few participants to carry the load.
This article discusses approaches to compensating angel group managers whether they are group members or hired from the outside. It also discusses the effects of an angel group’s investment structure on available methods of compensation.
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| Mr. World Court: An Interview with Foley Hoag's Paul Reichler |
Jan 28, 2009 |
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General |
Download |
From Central America to the Caucasus, Foley Hoag’s Paul Reichler has carved out a unique practice as the giant-slayer of public international law.
SUMMARY
Excerpt:
The American Lawyer (January 2009) - On October 17 the International Court of Justice ordered Georgia and Russia to refrain from ethnic cleansing in Russian-occupied Abkhazia and South Ossetia while Georgia’s complaint against Russia is being heard. It was the first invocation of the 1965 U.N. Convention on the Elimination of All Forms of Racial Discrimination by the World Court, which usually concerns itself with mundane border disputes.
But it was not the first ICJ case that Foley Hoag’s Paul Reichler helped to bring against a present or former superpower. Reichler catapulted to fame in 1984 at age 36, when he launched a suit—on behalf of Nicaragua—against the United States for its paramilitary activities in Central America. As Reichler says, “I’m surely the only lawyer to have sued both the U.S. and Russia in the International Court of Justice.” And, he might have added, won. While the World Court enjoined violence on both sides in the Caucasus—and some observers blame Georgia for provoking the confrontation—Georgia sought the injunction, and it is Georgians who most need its protection. (continues...)
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| Labor & Employment Brochure |
Jan 26, 2009 |
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Brochure |
Download |
SUMMARY
Providing strategic advice and litigation services to our business clients nationwide
Our long-standing strength in representing employers in labor relations and employment litigation defense issues is complemented by our experience in dealing with the emerging issues confronting employers in the 21st century.
Our goal is to provide pragmatic business advice and a cost-effective approach aimed at helping our clients achieve results – prompting those clients to place our Labor and Employment lawyers at the top of the Chambers USA rankings for four consecutive years.
Topics include:
- Labor Law Strategies
- Wage and Hour Litigation
- Non-Competition Agreements and Related Issues
- Employment Discrimination and Harassment Litigation
- Wrongful Discharge and Other Disputes
- ERISA and Benefi ts-Related Litigation
- Business Immigration Services
- Preventative Counseling
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| Government Strategies Data Sheet |
Jan 23, 2009 |
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Brochure |
Download |
Collaborating With You to Achieve Effective Public Policy
SUMMARY
Republished January 23, 2009
We believe that public policy should enhance the lives of citizens—and that can best be accomplished through partnership with business. Foley Hoag’s Government Strategies practice is focused on achieving results for our clients that are mutually beneficial to everyone involved.
We work with Fortune 100, start–up businesses and other clients to help develop effective new public policy, assess the impact of recent regulations and refine the implementation of enacted legislation.
We will help you overcome your legal, policy, and political challenges by:
- Providing strategic management of complex legislative and regulatory issues
- Building lasting relationships with key decision makers
- Anticipating future policy challenges and advising you accordingly
- Building coalitions to advocate on behalf of shared interests
- Providing counsel through crisis management and congressional investigations
- Enhancing understanding of agency decisions, authority and statutory changes
- Monitoring all types of legislative activities and advising you of their status
- Negotiating with regulatory agencies
The core strength of Foley Hoag’s Government Strategies practice is the unsurpassed experience of our lawyers. Most of our government strategies lawyers have worked in senior-level positions in the White House, on Capitol Hill, in regulatory agencies, and in industry trade associations.
Our trademark is a unique combination of broad-based legislative and regulatory experience and significant substantive knowledge, particularly in the following areas:
- Life sciences, including pharmaceuticals, biotechnology and medical devices
- Energy and regulated industries
- Energy technology and renewables
- Education
- Foreign policy and interactions with sovereign governments
- Corporate social responsibility
- International trade
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