GUEST EDITORIAL
	New Technologies for Ancient Diseases Carl B. Feldbaum
	FEATURE ARTICLES
	IP Due Diligence and the Value Proposition: Developing and Evaluating BioPharma IP Portfolios for Strategic Investment Benefits Bruce D. Sunstein
	Biotech Patent Licensing: Key Considerations in Deal Negotiations Jeffrey P. Somers
	Proposed Revisions to NASDAQ and NYSE Corporate Governance Listing Standards May Require Adjustments to Corporate Boards of Directors John B. Steele
	The Importance of Records Management for Biotech and Life Sciences Companies Daniel B. Trinkle and Breton Leone-Quick
	Post 9/11 United States Business Immigration Law: Fundamentals on Transferring, Recruiting and Retaining Foreign-Professionals for Work in the U.S. Biotech & Life Science Sector Salomon Chiquiar-Rabinovich
	Beyond the Patented Genome: Protecting Discovery in the New Biology Estate Space Arie M. Michelsohn
	SPECIAL SEGMENT KNOWLEDGE MANAGEMENT
	Knowledge Management Introduction Robin JR Blatt and Yoram Yahav
	Getting to Know the CKO: Defining the Role of the Chief Knowledge Officer Lester Thurow
	Truth Be Told: Utilizing Truth-Telling Analysis in Business Shlomo Maital
	Debriefing as a Core Competence in Business: The Israeli Air Force Sets the Debrief Standard Alon Dumanis
	Minding Your Own Database Maya Racine Netser
	Out of Sight, On the Mind: Facing the Challenge of Measuring Intangibles Baruch Lev
	BIOCOLUMNS
	Insurance Navigating the International Insurance Market Frank F. Goudsmit
	Intellectual Property What’s In Your Intellectual Property (IP) Audit? Henry N. Wixon
	Regulation Profits Lure Drug Companies into Hatch-Waxman Act Loopholes Timothy M. Murphy and Shaun P. Montana
	Financing Biotech Investors Still Sitting on the Sidelines G. Steven Burrill

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New Technologies for Ancient Diseases Carl B. Feldbaum

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Intellectual Property (IP) due diligence should be more closely linked to the target company's value proposition than is commonly supposed. Whereas classical IP due diligence determines whether a company owns its IP and can carry on its business without infringing third party IP rights, more informed IP due diligence also determines to what extent a company's IP has been developed to protect the company's value proposition against erosion by competitors. Generally a company's IP portfolio can achieve this status only when there is an intentional focus by the company on shaping both business strategy and IP strategy in relation to one another. When these two strategies are congruent, the company's IP portfolio will protect its value proposition. Just as company management needs to align its IP portfolio with its value proposition, IP due diligence by the potential investor needs to determine the extent of such alignment in order to properly assess the company's IP portfolio. (6 Pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: This article addresses certain key contractual and intellectual property considerations that frequently arise in the drafting and negotiation of license agreements in the biotech industry, and in particular license agreements for engineered compounds or biological materials. For ease of reference and in order to avoid becoming bogged down in matters of science (which are beyond the scope of this article), these will be simply referred to as the "Compound", and it is assumed that the licensor has a proprietary interest (either as the patent owner or as the exclusive licensee from a third party) in the Compound that is the subject of the license agreement. The excerpted Collaboration and License Agreement included as an Appendix illustrates the issues discussed in the article.

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Over the past year, the Securities and Exchange Commission and other regulatory authorities have proposed numerous initiatives to improve corporate governance of public companies. The initiatives will likely require changes to the composition of many boards of directors of public biotechnology and pharmaceutical companies as well as the adoption of additional controls and procedures. The following article summarizes the initiatives proposed by The Nasdaq Stock Market and the New York Stock Exchange. (8 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: This article examines the increasingly important role that a proper Records Management Policy plays for biotech and life sciences companies. An effective Policy can help a company attract investors, secure funding, and protect their intellectual property (IP). A well-designed policy will also protect companies in the event of civil or criminal litigation or investigations. Finally, this article offers some practical guidance for creating an effective Policy, and discusses some of the more complex issues biotech companies face in managing their records. (5 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: American biotechnology and life sciences companies, together with international firms with a United States (U.S.) presence, face the constant challenge of transferring, recruiting and retaining key foreign-professionals for work in the U.S. This article provides a current basic overview of the U.S. business immigration law for employing in the U.S. foreign nationals in light of the largest reorganization of the U.S. Government resulting from the terrorist attacks on September 11, 2001. (16 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: IP protection is essential to the pharmaceutical industry because the costs of innovation far exceed the costs of production. The New Biology offers massively parallel, high-throughput approaches to achieving milestones on the long road to drug discovery. The past several years has witnessed a significant upsurge in the patenting of New Biology discoveries by a diverse array of stakeholders holding a diverse array of claims. Those claims have started to make their way to court, where they have confronted various legal hurdles and logistical obstacles to enforcement. Whether New Biology claims will change the nature or role of IP in the pharmaceutical industry will likely depend on the ability of the New Biology to actually reduce the huge costs of drug discovery by honing in efficiently on the most likely targets for and agents of safe and effective therapeutic intervention. (6 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Daily fluctuations in the stock market determine the value of the world's often most valuable firm, Microsoft. It owns no land, no gold, no oil, no buildings and no machines, so what makes it valuable? Its control of a knowledge process. Put simply, in a knowledge economy the management of knowledge becomes central to economic success. This article discusses the role of the Chief Knowledge Officer in today's corporate environment. (2 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The gap between what we say and what we mean, is often enormous and this has major implications in the business setting. The first step toward creating a learning organization is teaching individuals and organizations to tell the truth. This article describes single-loop and double-loop learning and highlights the use of truth-telling analysis in the business setting. (2 pages)

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Abstract: Effective debriefing is one that focuses on the system and organization, not on the individual. This article provides an overview of the use of debriefing as an effective learning tool in the corporate setting. (2 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: There is no doubt that databases are a commodity comprised of both commercial value and social utility, which typically contain confidential information and fruits of creativity. The use of proprietary assets such as databases requires special care and consideration of the different forms of intellectual property rights embodied in databases. This article discusses the need for database protections in the Information Age. (3 pages)

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Abstract: Measuring intangible assets is a critical component of business systems. When linkages are made between inputs and outputs for intangibles, with attributable benefits, it should be possible to assess return on investment. This article highlights the challenges of measuring intangibles and offers some concrete suggestions for integrating this into corporate practice. (2 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Biotechnology is a global business, with more United States (U.S.)-based biotechnology companies conducting clinical trials and establishing facilities overseas. This article identifies some of the risks facing biotechs that conduct business or research in foreign countries. It also provides information that can help biotech firms navigate the intricate web of international insurance issues. (4 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Without exception, biotech CEO's understand that intellectual property (IP) is important to their business. At any stage in the growth and development of a company, it is critical to know and to understand what intangible assets exist. A start-up seeking venture capital funding is well advised to first get its intellectual property house in order through an internal IP audit, or else risk an unpleasant surprise when the lead investors walk because their diligence reveals an unexpected deficiency. And any company required to employ U.S. GAAP (Generally Accepted Accounting Principles) must identify and value its IP, and include those valuations on its balance sheet, under FASB (Federal Accounting Standards Board). This article discusses the process of conducting an IP audit and the benefits of creating an inventory of intangible assets within life science companies. (2 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The high profits commanded by certain drugs have lead some pioneer drug companies to take advantage of the complexity of the Hatch-Waxman Act to extend their rights to exclude generic drug manufacturers from introducing competing products. The article focuses on several drugs sold by Bristol-Myers Squibb (BMS), the patent issues raised by BMS's attempts to extend its exclusive rights to sell these drugs, and the anti-trust suits which followed as a result of BMS's tactics. (6 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: For most of the first quarter of 2003 the biotech industry has hung on while investors waited on the sidelines. The uncertainty generated by the continuing war in Iraq forestalled positive movement for biotech companies, while reorganization, restructuring, industry consolidation, and collaboration continued to dominate the news. This article highlights financing trends in biotechnology and the life sciences. (2 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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