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Name and title: W. Bradford Middlekauff, senior vice president, general counsel and secretary Age: 43 The company: Medarex Inc. is a biotechnology company devoted to the development of antibody-based products used for treating cancer and other life-threatening and debilitating diseases. Its business revolves around its “UltiMAb” proprietary technology through which fully human antibodies are raised in specially engineered mice. The process potentially reduces the time and cost of drug development and skirts the possible pitfalls of using a human host. Also, as antibodies are naturally occurring proteins, antibody-based medicines are presumably less toxic than chemical-based ones. Established in 1989, Medarex is based in Princeton, N.J., with laboratories, manufacturing facilities and offices in Bloomsbury and Annandale, N.J., and Sunnyvale and Milpitas, Calif. The publicly traded company has 435 employees, and reported 2004 revenues of $12.5 million. Transaction-oriented: Bringing deals to fruition represents a substantial part of Middlekauff’s duties. “To develop a drug and get it to the market can take eight to 10 years if things work out well . . . .It can cost hundreds of millions of dollars. There are very few biotech companies that have those sorts of resources, [so] it’s almost inevitable that you are going to look to partner the technology with, typically, a large pharmaceutical company. Transactions like that are really the lifeblood of biotech companies.” Besides developing products based on its core technology, Medarex thus also makes the process available to others. Middlekauff cited more than two dozen such partnerships, “a who’s who of the American pharmaceutical world,” including Pfizer Inc., Eli Lilly and Co., Schering-Plough Corp., Novartis Pharmaceutical Corp. and Johnson & Johnson. In licensing the technology, Medarex receives “milestone payments” should the pertinent products reach certain phases in the three-stage clinical development process, and the firm also receives royalties should they ultimately enter the marketplace. Middlekauff described biotech as “a very entrepreneurial world” of high risks and high rewards. He emphasized its scientific, clinical and regulatory uncertainty, governed by continually evolving patent laws, during a time in which safety issues are discussed in the press and Congress. Major deals: A Medarex product, used to combat metastatic melanoma (and the one most advanced in the U.S. Food and Drug Administration (FDA) process), was the centerpiece of a recent deal with Bristol-Myers Squibb Co., culminating an 11-month negotiation period. Middlekauff’s firm received $50 million upon signing, and stands to earn $480 million more in milestone payments. The anti-melanoma product was cross-licensed to Pfizer, in a deal worth $110 million at signing, and with the prospect of milestones similar to those in the Bristol-Myers contract. Middlekauff and his team also recently arranged a lucrative deal with the pharmaceutical division of Japan’s Kirin Brewery Co. to pool “mice-creating” technology, resulting in the “KM-Mouse,” a unique crossbreed of human-antibody-producing mice. Day-to-day duties: Middlekauff cautioned that “once you enter into a deal, the lawyer’s job is not done. You must make sure to comply with the terms.” He also handles corporate governance, but noted that with the passage of time since the enactment of Sarbanes-Oxley regulations, and with systems and guidelines now in place, Medarex is now in more of a “steady state” maintenance phase of compliance. The firm must also adhere to “current good manufacturing processes” rules promulgated by the FDA regulating sales and manufacture of pharmaceuticals and codifying clinical trials. Although not on the front line of contact with the FDA, Middlekauff counsels and participates in strategy sessions with those who are, notably Medarex’s clinical and regulatory groups. He arranges for insurance to cover clinical trials and also ensures coverage if the product makes it to market, “where you have significant exposure and must be well covered.” Although not a lobbyist himself, Middlekauff is an executive on the general counsel’s committee of the Biotechnology Industry Organization, a large and influential group in Washington that “tries to move Congress in what we see as the right direction” in terms of policy. Participation in the organization’s three annual meetings helps to keep him abreast of the latest issues, and he also relies upon publications such as BioWorld Today and BIO Century. Legal team, outside firms: Five attorneys are under Middlekauff’s supervision: two transactional, two patent and one specializing in corporate, securities and employment matters. This core group is supported by a contracts manufacturer, a patent agent and a couple of administrators. Middlekauff reports to Chief Executive Officer Donald Drakeman. An estimated two-thirds of the work is performed in-house, with the general counsel calling upon the following firms as needed: New York-based Satterlee Stephens Burke & Burke (corporate and securities); Washington’s Covington & Burling (partnering and strategic alliances); Palo Alto, Calif.’s Cooley Godward (patents); New York’s Darby & Darby; and Boston’s Lahive & Cockfield. Route to the top: Middlekauff graduated from Brown University in 1983. After receiving a juris doctor degree from Yale Law School in 1991, he clerked for Judge Robert Ward of the Southern District of New York, an early career highlight. Next he joined Cooley Godward, where from 1993 to 1998 he advised life sciences companies on research and development; partnering, licensing and financing; and product commercialization-all focal points of his current job. Moving in-house to Neptune, N.J.’s Algos Pharmaceutical Corp. in August 1998, he became its vice president, business development, and general counsel. He has been with Medarex since March 2000. Personal: Cincinnati-born Middlekauff and his wife, Dr. Nancy Goldin, are the parents of a pair of sons: Jacob, 8, and Noah, 5. He enjoys “going on adventures with my kids” in his spare time. Last books and movie: A Short History of Nearly Everything, by Bill Bryson; The Austere Academy: Book the Fifth (A Series of Unfortunate Events), by Lemony Snicket and Brett Helquist; and Million Dollar Baby.

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