Foley Hoag LLP

SUMMARY

On July 15, 2008, the Securities and Exchange Commission (“SEC” or the “Commission”) issued an emergency order (the “Order”) to enhance investor protections against “naked” short selling in the securities of Fannie Mae, Freddie Mac and primary dealers at commercial and investment banks (the “Securities”), which are identified in Exhibit A (.pdf). The Order was issued pursuant to the Commission’s authority under Section 12(k)(2) of the Securities Exchange Act of 1934. In addition, the SEC will undertake rulemaking to address these issues across the entire market.

Under the Order, anyone effecting a short sale in the Securities must arrange beforehand to borrow the Securities and deliver them at settlement. The Order took effect at 12:01 a.m. ET on Monday, July 21, 2008 and will terminate at 11:59 p.m. ET on Tuesday, July 29, 2008. The SEC may extend the Order if the SEC determines that the continuation of the Order is necessary in the public interest and for the protection of investors, but not for more than 30 calendar days in total duration.

SUMMARY

The Securities and Exchange Commission (“SEC”), Financial Industry Regulatory Authority (“FINRA”) and New York Stock Exchange Regulation, Inc. (“NYSE Regulation”) have taken unprecedented steps in response to the concern that the stock collapse of Bear Stearns and Lehman Brothers resulted from the spread of false and misleading rumors, and that the rumors may have been linked to “naked” short selling.  

SUMMARY

Understanding Medicare coverage and payment policy is critical to the successful launch of any new life sciences technology. Foley Hoag’s Medicare Coverage & Payment Practice provides regulatory and legislative advice to a broad array of leading life sciences companies, including:

• global pharmaceutical and biotechnology firms,
• trade associations,
• venture capital and investment funds,
• patient associations and advocacy groups, and
• early-stage companies.

SUMMARY

Foley Hoag’s Food and Drug Practice provides regulatory and legislative advice to leading biotechnology, pharmaceutical, medical device, and health care companies regulated by the Food and Drug Administration (FDA). Lawyers at Foley Hoag understand the critical regulations and policies affecting product development schedules, regulatory compliance, and timely product approvals. In representing clients, our lawyers work with senior agency managers, congressional staff, and Members of Congress to shape agency interpretations, clarify regulatory guidance, challenge adverse decisions, develop effective compliance plans, and enact legislation into law.

SUMMARY

Included in this Issue:

• A Market Perspective: Foster Hinshaw on 'B' Rounds - Opportunity in 'Gloom and Doom'

  In 2002, during the valley of the tech bubble burst, one of the most respected VC’s in the tech community said to me, "It’s all about survival, survival, survival – I don’t know if we will ever recover". Notwithstanding, the resiliency of our tech community proved its intrinsic value to the economy and there were some nice IPO’s and exits from companies that were incubating during the bubble years (including FAST, EqualLogic and Netezza). Today the news is similar: (a) zero IPOs in Q2 2008; (b) the financial sector is in a major, albeit predictably cyclical, reset; and worse (c) another 1970’s style energy crisis is on us. (continues...)

• Selected New England "Series B" and Later Round Transactions
• Terms of New England Series B and Later Rounds
• The Activity Level Summary

SUMMARY

Last week, the U.S. Supreme Court held in Metropolitan Life Insurance Co. v. Glenn, that a conflict of interest exists if an entity such as an employer or an insurance company evaluates claims for benefits under an employee benefit plan and also pays out those benefits from its own pocket. This conflict does not disqualify entities from occupying this dual role, however the dual role will be considered as a factor in determining whether the plan administrator abused its discretion in denying benefits. The decision is significant because it affects the plan administrator’s discretionary authority to determine eligibility for benefits and to construe the terms of the plan. Employers now need to worry about such a conflict whenever they make determinations about whether employees are eligible for benefits.

SUMMARY

On June 16, 2008, the SJC issued its much-anticipated decision in Michael D. Bank et al v. Thermo Elemental, Inc. et al., clarifying that line-by-line compliance with “every detail” of the Massachusetts Contingency Plan (MCP) is not a prerequisite to recovery of any of the response costs incurred by a property owner via the cost-recovery provisions of the MCP in MGL Chapter 21E.  The SJC also confirmed that attorneys fees incurred in implementing a site cleanup – as opposed to litigation-related attorneys’ fees – are recoverable as response costs under Chapter 21E.

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

SUMMARY

According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which includes biotechnology and medical devices, accounted for 28% of VC money invested, the largest investment sector in 2006.

As Life Sciences venture capital investing has risen, the biotechnology industry has become increasingly dependent on such funding. This is particularly true for start-up companies that cannot rely on revenue from marketed biologics to fund their research and development pipeline. To cover the nearly $1 billion capital investment required to bring a biologic drug to market (from discovery through clinical trials and FDA approval), early-stage companies rely on VC investing. Investing in emerging companies, however, is risky for a venture capitalist: only 1 in 10 drugs discovered actually makes it to market, and despite the more than $50 billion spent on biotech drugs in 2006, the great majority of early-stage companies never reach the point of net profitability.

SUMMARY

Preface:

Patenting generally offers a superior means for legally protecting most inventions, particularly since:

• copyright, when available, does not provide a broad scope of protection; and
• the ability to effectively protect an invention as a trade secret is in constant jeopardy, due to publication or oral disclosure.

Unfortunately, the patenting process can be complicated, time-intensive and costly. However, costs can often be minimized and opportunities for establishing value in products and technology maximized if scientists and business professionals with an understanding of the patenting process are actively involved throughout.

This publication was prepared to provide an overview of patenting, particularly as it pertains to innovative technologies such as biotechnology and information technology.

SUMMARY

On June 16, 2008, Massachusetts Governor Deval Patrick signed into law legislation (.pdf) that provides a total of $1 billion over the next ten years to support the development of the life sciences industry in Massachusetts. The legislation, commonly known as the Life Sciences Initiative (LSI), is designed to stimulate research, development, manufacturing, and commercialization in the life sciences sector and, ultimately, to increase employment and associated tax revenues. To achieve these goals, the LSI significantly expands the activities of the recently created Massachusetts Life Sciences Center (LSC) by dramatically increasing the funding available for capital expenditures, grant programs and other incentives. The LSI also establishes an aggressive set of tax incentives that include a broad array of refundable and other types of tax credits. 

SUMMARY

While the debate over federal climate change regulation continues, several US states and regions have enacted their own programs. One of the first to act was Massachusetts, which in 2001 promulgated carbon limitations applicable to six existing power plants. Those regulations established an emission limit of 1,800 pounds of carbon per MWh and sharply limited the use of many types of carbon credits to meet the specified carbon targets. The regulations also allowed Massachusetts Department of Environmental Protection (“DEP”) to invoke a “safety value” if DEP determined that the Massachusetts requirements could not otherwise be achieved. Earlier this month, DEP determined just that and opened up its carbon markets. Although this individual action affects only a few sources and only for emissions generated in 2008, it is indicative of some of the regulatory flexibility that will be needed as regulators and regulated sources begin to grapple with the practicalities of climate change regulation. Most interested observers believe that climate change regulation will only continue to increase, but precisely how that process will unfold remains to be seen.

SUMMARY

Established in December 1980 by the partners of law firm Foley Hoag, The Foley Hoag Foundation is a private foundation that seeks to combat racism, especially among youth, in the City of Boston. The Foundation awards grants to organizations working to improve the racial climate in Boston by addressing issues of diversity and racism. Grantee organizations achieve their goals through a variety of means, including arts and cultural activities, youth leadership and recreational programs. Other grantees provide advocacy assistance, enabling individuals to confront racism through legal or political action. Some grantee organizations work to prepare young children to live in the reality of a multicultural society, others engage teens, and a few target a primarily adult constituency.

The Foley Hoag Foundation was the first—and remains the only— foundation to focus exclusively on the improvement of race relations in Boston. The trustees are fortunate to have the unqualified endorsement of Foley Hoag, which has provided an enormous amount of financial, administrative and moral support.

SUMMARY

Included in this Issue:

• A Market Perspective: Axel Bichara on the State of the Technology Industry

  Technology innovation has been accelerating during the last centuries and will continue to do so. Innovation helps drive entrepreneurship and new business opportunities. That’s good news for entrepreneurs and early-stage investors in the US where the state of innovation andentrepreneurship continue to be exceptional. There are plenty of excellent startup opportunities. The funding environment for start-ups will remain strong, with an abundance of capital from both VC and private investors. (continues...)

• New England First Round Transactions

SUMMARY

Despite the fact that securities fraud lawsuits involving auditors are said to be relatively few in number as a percentage of total new filings and new filings are below the historical average, auditors often come to be added as defendants, particularly in high-profile cases.1 In the past few years, for example, auditors have been named as parties in the five proceedings with the largest total dollar value settlements to date -- Enron, WorldCom, Cendant, Tyco and AOL Time Warner -- and in several other well-known actions including Global Crossing, Parmalat and Delphi. With the majority of all cases historically alleging accounting irregularities and over 90% of last year’s filings reportedly containing alleged misrepresentations in financial documents, suits against auditors are never far off.

This article reviews first the role of the auditor and reminds counsel of the benefits of understanding and educating the court regarding the role of the auditor, namely that the auditor does not prepare a company’s financial statements; rather, the auditor opines on the fair presentation of management’s financial representations based on the auditor’s testing those representations. This article then surveys three areas of law germane in suits against auditors: (1) scienter requirements with respect to auditors; (2) the scope of primary liability and “scheme” liability with respect to auditors; and (3) “one firm” theories asserted against international audit firms.

SUMMARY

The Prescription Drug Marketing Act was enacted in 1988 to establish, among other things, a system for tracking drugs through the manufacturing and marketing processes. implementing regulations regarding these pedigree provisions for prescription drugs have been delayed for years. The Food and Drug Administration has issued it’s own stay on implementation, and a recent lawsuit by prescription drug distributors over the scope of the pedigree requirements has contributed to the delay as well.

The resulting lack of clear of federal criteria for prescription drug pedigrees has created an opportunity for states to pass their own pedigree laws, leading to a patchwork of diverse, often conflicting, state standards. Prescription drug distributors find it increasingly difficult to comply with the multitude of state laws, thus the time is ripe for federal action to create uniform pedigree requirements.

SUMMARY

While marking products to indicate that they are patented is necessary to maximize your patent rights, a recent case highlights the importance of marking the products accurately.

SUMMARY

Health Canada released a draft guidance this week which would allow approval of “subsequent entry biologics” (SEB) based on an abbreviated complement of clinical data, provided the SEB is shown to be “similar” to a reference, approved biologic product.[1] While the U.S. continues to heatedly debate legislation which would create a pathway for abbreviated approval of biosimilars, or follow-on biologics, by the U.S. Food and Drug Administration (FDA), Canada is advancing its implementation of such a pathway with the release of the SEB draft guidance. The European Union has permitted approval of biosimilar products since 2005.

Like FDA guidance documents in the U.S., Health Canada guidance documents do not have the force of law in Canada. However, the draft guidance indicates that the Canadian Food and Drug Regulations will be amended to provide “a comprehensive legal basis” for the regulation of SEBs and that in the interim, the draft guidance will provide a flexible SEB regulatory framework. The Canadian Minister of Health also plans to publish additional guidance documents that will further elaborate information and data requirements for specific classes of SEBs. Public comments on the SEB draft guidance are due April 16. 

SUMMARY

Two recent developments, one by the Massachusetts Department of Environmental Protection (“MassDEP”) and one by ASTM International (“ASTM”), underscore the importance of addressing indoor air contamination that results when soil or groundwater contamination migrates as vapor.  On the regulatory side, MassDEP has emphasized its focus on this issue by issuing a flurry of draft guidance and procedures.  From an industry perspective, ASTM recently released a new industry standard for assessing indoor air contamination at properties that are the subject of real estate transactions.  As MassDEP’s draft standards are regulatory in nature and appear stricter than the ASTM standard, the ASTM standard may be of limited relevance here in Massachusetts.  However, it may serve to set the standard of care in states where Superfund regulations on this topic are not as detailed as those in Massachusetts.

SUMMARY

Key Members of the House Committee on Energy & Commerce have introduced bipartisan legislation which would create an abbreviated approval pathway for biosimilars or follow-on-biologics (FOBs). The Pathway for Biosimilars Act, H.R. 5629 introduced by Congresswoman Anna Eshoo (D-CA) and committee ranking member Joe Barton (R-TX), enhances the prospects for congressional action in 2008, following Senate HELP Committee action last year on S. 1695, a comparable bipartisan bill introduced by Senators Kennedy, Enzi, Clinton and Hatch.