Advising e-Commerce Business Startups: A Crib Sheet
February 27, 2007
In the first of a two-part article, our expert author examines some issues that e-commerce counsel should pay particular attention to when advising e-commerce startups, particularly small, single-entrepreneur or small-group driven Internet-based storefronts.
Do You Know What Companies Really Want?
February 27, 2007
In the 20 years I have worked with and for in-house counsel and CEOs, this recent statement to me by a Fortune 100 senior in-house counsel is the strongest yet. Over the years I've compiled a number of such statements, which, if more moderate in tone, are equally serious in intent. Many of them zero in with a great deal of specificity on buyers' discontent and, as such, are particularly helpful, if disconcerting.
In the Spotlight: Planning for Redevelopment
February 27, 2007
For years, the commercial real estate market has been sizzling.Cap rates are down. Prices are up.Nevertheless, you managed to beat out the competition and buy a few shopping centers. To justify the price you paid, however, you need to increase the net operating income ('NOI') from your property. Now, however, the economy may be facing the headwind of a slowdown, if not an outright recession, which creates resistance to rent increases; so you may not be able to rely on ordinary rent increases to bolster your NOI.
Hedge Fund Analysis and Valuation
February 27, 2007
Determining the value of a hedge fund investment is completely different from and far more complex than the relatively straightforward way of determining the value of shares of a publicly traded stock. During the past 10 years, the explosive growth of the hedge fund industry has made the analysis of hedge fund investments and hedge fund businesses an increasingly common part of the financial due diligence necessary in matrimonial cases.
FDA's New Quality System Guidance: Minimizing a Pharmaceutical Company's Risk
February 27, 2007
On Sept. 29, 2006, the Food and Drug Administration ('FDA') issued a final guidance on quality systems for pharmaceutical companies: formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product and service requirements, improve customer satisfaction, and ensure continual improvement. The 'Quality Systems Approaches to Pharmaceutical Current Good Manu-facturing Practice Regulations' (the 'Guidance Document') is intended to help companies comply with the FDA's current Good Manufacturing Practices ('cGMP') regulations. The Guidance Document is part of the FDA's Pharmaceutical cGMPs for the 21st Century Initiative, a program that seeks to integrate quality systems and risk management approaches into existing manufacturing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
The Changing Face of FDA Consent Decrees
February 27, 2007
Historically, when a health care company had a compliance failure, counsel could help it remain in business by negotiating with the relevant agency. If the problem involved sales, marketing or pricing, the company could seek a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) at Health and Human Services (HHS). If the problems related to manufacturing, counsel could obtain a consent decree of permanent injunction ('consent decree') with the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act (FDCA). Consent decrees and CIAs each had their particular burdens and benefits, which health care practitioners had learned to navigate. Now this tidy distinction has become blurred as the FDA has borrowed features from HHS's CIAs.
Predicting Bondholder Activism
February 26, 2007
The image of bondholder activism in many quarters is one of rapacious bondholders aggressively pursuing a ruthless quest for returns. The reality is far more complex, but the outcome of particular cases may be surprisingly predictable for the astute analyst.
