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Name and title: Caroline B. Manogue, chief legal officer, executive vice president and secretary Age: 36 The company: Endo Pharmaceuticals Inc., headquartered in Chadds Ford, Pa., is a leading maker and seller of prescription medication for the treatment and management of pain. Endo was formed in 1997 when DuPont Merck Pharmaceutical Co. sold off several pain medicine brands to a company formed by ex-DuPont Merck executives Carol Ammon and Mariann MacDonald. The company went public after purchasing Algos Pharmaceutical Corp. in 2000. The 600-employee company reported $615 million in net sales for 2004. Legal staff: Caroline B. Manogue has been Endo’s top lawyer since September 2000, when she was hired away from outside counsel Skadden, Arps, Slate, Meagher & Flom of New York, where she was a mergers and acquisitions specialist. Manogue reports to Chief Operating Officer Peter Lankau, and supervises four other in-house lawyers: Douglas Macpherson, who is responsible for corporate development; Guy Donatiello, who handles intellectual property; senior commercial attorney Jill Dailey; and senior staff attorney Tanya Edmonds. The law department also includes three paralegals and two administrative assistants. Endo’s main outside counsel is Skadden Arps, which handles securities work, litigation, business development and licensing. For regulatory work, Manogue also calls on Washington-based firms Arnold & Porter and Wiley Rein & Fielding. Pills and patents: In October 2000, six weeks after Manogue joined Endo, the company was sued by Purdue Pharma L.P. in federal district court in New York. The suit alleged that Endo’s generic version of OxyContin violated three of Purdue’s patents on the popular pain medication. “On my first day here, Carol [Ammon] said, ‘We may be sued soon by this company named Purdue,’ ” said Manogue. “ She filled me in on the details, and I said, ‘OK, I think we can handle this problem.’ “ The ongoing litigation has proven to be much more time-consuming and labor-intensive than anyone at Endo had anticipated. “Purdue understandably fought very hard and continues to fight very hard, but we’re confident that we’ll ultimately prevail,” said Manogue. Endo filed patent and antitrust counterclaims charging that Purdue’s patents on OxyContin were invalid because Purdue had fraudulently misrepresented medical claims before the U.S. Patent and Trademark Office. Manogue has been very “hands on” in overseeing this case, which has become a crash course in intellectual property law for the former corporate lawyer. She has worked closely with counsel at Skadden Arps and Kramer Levin Naftalis & Frankel in preparing the pleadings, and attended every day of the June 2003 trial. In a January 2004 ruling, U.S. District Judge Sidney H. Stein found that Endo infringed Purdue’s patents, but ruled that the patents were unenforceable due to Purdue’s inequitable conduct. Purdue Pharma L.P. v. Endo Pharms. Inc., 70 U.S.P.Q.2d 1185 (S.D.N.Y. 2004). The Federal Circuit heard argument on Purdue’s appeal, and Endo’s protective cross-appeal, on Nov. 3, 2004. Manogue pronounced herself “very pleased” with the district court ruling, and predicted that the company will win the appeal. However, the company has decided to delay launching its generic OxyContin until after the appellate ruling, she said. New drugs: Although Endo started out primarily as a generic drug company, the company has expanded its portfolio of brand-name drugs, which now account for about 70% of total sales. Endo’s major brands include best-selling pain medications Percocet and Percodan. The company’s regulatory department takes the lead in securing approval by the U.S. Food and Drug Administration (FDA) for Endo’s patented and generic medications. But Manogue’s shop plays a key role in negotiating Endo’s licensing agreements to market other firms’ pharmaceuticals. Her 2004 transactions included a licensing agreement with SkyePharma Inc. to market DepoDur, a morphine injection used for post-surgical pain management, and an agreement with Orexo A.B. for exclusive rights to develop and market Rapinyl, a pill to treat cancer pain. “We do as much due diligence on our licensing transactions as we do when purchasing companies,” said Manogue. Endo’s lawyers check out the bona fides of the licensing partners’ patents and trademarks, technical expertise, regulatory compliance and marketing history, she said. Manogue has been involved in 11 major corporate deals since joining Endo: “Milestones, indemnification and marketing efforts are all heavily negotiated.” For example, she helped negotiate Endo’s licensing agreement with Vernalis Development Ltd. for exclusive North American marketing rights on the migraine drug Frova. In addition to the standard terms, representations, warranties, indemnification and termination clauses, the agreement called for a $30 million upfront fee, two $15 million annual payments, a $40 million bonus if the FDA approves the drug for treatment of “menstrually associated migraines” and royalties and up to $255 million in premium payments pegged to sales. Route to the top: The Green Township, N.J., native graduated cum laude from Middlebury College in 1990. After college, Manogue worked for two years as a paralegal at Skadden Arps, which subsidized her 1995 J.D. from Fordham University School of Law. Manogue returned to Skadden as an associate in the mergers and acquisitions group. “It was very demanding, it was very tough, and I loved it,” she said. Under the tutelage of partners Eileen Nugent and Lou Kling, Manogue worked on several corporate acquisitions, including Endo’s 2000 acquisition of Algos Pharmaceuticals, which segued into her hiring by the company. The switch from Wall Street lawyer to in-house lawyer was initially daunting. “At first, I didn’t know much about the [pharmaceutical] industry, and I had to build up the department from scratch. For the first month or so, I would stay up at night learning to pronounce the names of our products and their active ingredients,” Manogue recalled. “I’m fine now.” Personal: Manogue lives in the Philadelphia suburb of Gladwynne, Pa., with husband Christopher Manogue, their 10-month-old daughter Samantha and dog Daisy. Last books and movie: The Piano Tuner, by Daniel Mason, What to Expect the First Year, by Arlene Eisenberg, and Sideways.

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