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Serving the Life Sciences Industry

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Serving the Life Sciences Industry Powered By Docstoc
					Serving the
Life Sciences
Industry
Bench Strength at Every Stage of
the Product Life Cycle
King & Spalding’s life sciences practice is one of
the largest and most comprehensive in the United
States. More than 150 lawyers and professionals in 11
practice groups located in eight offices coast to coast
devote all or a substantial portion of their practices
to clients in every segment of the industry. The firm
currently represents more than 200 pharmaceutical,
biotechnology and medical device manufacturers
overall, including 8 of the top 10 pharmaceutical/
biotechnology manufacturers and 8 of the top 10
medical device manufacturers.

We offer pharmaceutical, biotechnology and medical
technology companies specialized experience at
every stage of the product life cycle — from emerging
growth company counseling on intellectual property
and clinical trials through licensing and finance to
FDA approval, manufacturing, marketing, commer-
cial and post-approval regulatory, transactional, and
litigation matters. Our government affairs lawyers
also help our clients in the industry understand and
navigate legislative and regulatory developments
in Washington, D.C., and in state capitals across
the country.

From start-up through product launch to patent
expiry, our clients rely on King & Spalding’s
substantive expertise, bench strength and
collaborative approach to client service.
360° Representation
At King & Spalding, we recognize that our clients
are committed to protecting and promoting their
businesses every day: as their legal partners, this is our
commitment too. Our lawyers work together across
all practice groups — one area of expertise informing
another — to provide our clients with cost-effective,
informed and strategic counsel based on a thorough
knowledge of the pharmaceutical, biotechnology and
medical device industries. This internal coordination
is essential to helping our clients identify and consider
future risks and preserve strategic options across the
full spectrum of their business activities. As one client
noted, “Cases can spill over into other things like
regulatory issues … King & Spalding can bring it all.”




“Clients value [King & Spalding]
 lawyers for their ‘knowledge of
 the courts and juries, and ability
 to get things done.’”
 – The Legal 500
                                                       01
Investing in the Life
Sciences Industry
Over the past decade, King & Spalding has
demonstrated its commitment to the life sciences
industry by investing in people and tools to better
serve our pharmaceutical, biotechnology and medical
technology clients, including by:

Developing, cultivating and reinforc-       Deploying internal knowledge man-
ing bench strength in every key area        agement systems focused on FDA-
of legal need, including intellectual       regulated manufacturers, ensuring
property, business and product              that our lawyers and professionals
liability litigation, government investi-   stay informed about key industry and
gations, FDA and government payor           business developments.
regulation, commercial contracting
and government advocacy and                 Offering aggressive training programs
public policy.                              both to internal lawyers and to clients
                                            focused on legal, regulatory and
Leveraging the expertise of non-lawyer      business developments of interest to
professionals (including more than          pharmaceutical, biotechnology and
30 MDs, PhDs and others with                medical technology companies.
advanced medical, scientific and
technical degrees) to provide counsel
and support that integrates legal,
regulatory, scientific and technical
expertise.

These investments and our integrated approach have
permitted us to represent our clients in the industry
on a more cost-effective basis with respect to a broader
array of legal issues.




                                            Our lawyers and professionals share
                                            industry developments with our
                                            clients through substantive programs
                                            and communications, including
                                            K&S Pharmaceutical University and
                                            the K&S Medical Device Summit.
                                                                                      03
Our Specialized Practices
Antitrust                                  Appellate                                 Business Litigation
King & Spalding’s antitrust lawyers        Lauded in Chambers 2010 as “really        King & Spalding litigators have
provide customized and solution-           making a splash in the national           extensive experience representing life
oriented advice to pharmaceutical          appellate scene,” King & Spalding’s       sciences companies in the kinds of
companies on all aspects of antitrust      national appellate practice is headed     cases that they regularly face, includ-
law, from civil and criminal litigation    by former Principal Deputy Solicitor      ing the litigation and arbitration of
to counseling on sales practices and       General Daryl Joseffer. Mr. Joseffer      licensing agreements and collabora-
merger approval. Recognized by             and former Acting Assistant Attorney      tion/joint-development agreements,
Chambers USA as “a sharp, practical,       General Jeffrey Bucholtz developed        supply and distributions agreements,
business-oriented group” that pro-         extensive expertise in pharmaceutical     acquisition agreements and post-
vides “a great mix of theory and           matters when handling such cases for      closing disputes, qui tam litigation,
practicality,” our antitrust lawyers       the U.S. government and are now           trade secret litigation and securities
also have been singled out by The          applying that expertise for major         class action litigation. Our lawyers
American Lawyer and The Best               pharmaceutical companies. In              have successfully represented life
Lawyers in America, among others.          addition to representing clients          sciences clients in virtually every
Our expertise in the pharmaceutical        before appellate courts, our lawyers      litigation forum, from federal and
industry includes antitrust litigation     provide strategic counseling and          state trial and appellate courts to the
before trial and appellate courts,         advice on legal issues well before they   U.S. Supreme Court, national and
including the U.S. Supreme Court,          reach the appellate courts. The           international arbitration panels,
on issues ranging from the settlement      appellate group recently argued a         government agencies and alternative
of patent litigation between brand         series of appeals in pharmaceutical       dispute resolution tribunals. We try
and generic companies to interna-          product-liability cases involving         high-profile cases on a regular basis,
tional cartel investigations. Our          federal preemption and other issues       representing clients in matters rang-
lawyers are equally skilled at planning    and represented a global                  ing from class actions to multi-dis-
and implementing strategies to gain        pharmaceutical and medical device         trict litigation, from complex busi-
U.S. and international antitrust           manufacturer in a declaratory             ness matters to small disputes and
approval for pharmaceutical mergers        judgment action challenging FDA           individual cases, and from arbitra-
and acquisitions. We also advise           regulations that prohibit truthful,       tions and mediations to negotiations
pharmaceutical clients on joint            non-misleading speech about off-          and investigations. The American
ventures and strategic alliances to        label uses of FDA-approved                Lawyer’s biennial Litigation
ensure compliance with U.S. and            prescription drugs.                       Department of the Year survey has
international antitrust laws. We                                                     listed King & Spalding as one of the
regularly appear before all key com-                                                 top litigation firms in the United
petition authorities including the U.S.                                              States four consecutive times.
Department of Justice, the Federal
Trade Commission, state attorneys
general and the European
Commission. Pharmaceutical clients
also turn to us for counseling on
benchmarking, distribution, market-
ing, pricing, trade association partici-
pation, and licensing practices includ-
ing the antitrust issues that arise from
authorized generics and the settle-
ment of patent claims between brand-
ed and generic drugmakers, and the
filing of notification with DOJ and
FTC pursuant to the Medicare
Modernization Act.




04 Serving the Life Sciences Industry
Corporate/M&A                             Discovery Center                          FDA & Life Sciences
Our corporate practice advises phar-      For more than 20 years, King &            Our FDA & life sciences practice is
maceutical, biotechnology and medi-       Spalding has been at the forefront of     ranked by Chambers USA as among
cal technology clients at all stages of   developing high-quality, cost-effective   the nation’s best for medical device,
their development and in connection       solutions to the challenges of collect-   pharmaceutical and biotechnology
with a wide variety of strategic corpo-   ing, reviewing and producing docu-        regulatory work. With more than 30
rate transactions, including financ-      ments in complex litigation. As a         lawyers and professionals in
ings, mergers and acquisitions,           primary part of these efforts, the firm   Washington, D.C., and Northern
product acquisitions and dispositions,    created the Discovery Center in 1995      California, we provide sophisticated
licenses, research and development        at the request of a client. The           counseling to more than 150 drug
agreements, co-promotion agree-           Discovery Center has been in con-         and device manufacturers. Our
ments, and supply and distribution        tinuous operation ever since, serving     integrated team includes attorneys
arrangements. The firm has more           more than 100 companies, including        with expertise in all areas of federal
than 150 corporate/M&A lawyers            some of the largest in the world.         and state regulation of the life sci-
located in Atlanta, Charlotte, Dubai,     Today, the Discovery Center houses        ences industry, from product develop-
Frankfurt, Houston, London, New           more than 180 experienced team            ment, clinical testing, approval and
York and Washington, D.C. Our             members dedicated solely to discov-       manufacture through commercializa-
M&A practice is consistently ranked       ery, due diligence and other docu-        tion and payment. We regularly advise
among the leading practices in the        ment-related matters in an off-site       manufacturers with regard to com-
United States, and King & Spalding        facility designed from the ground up      plex matters of FDA, CMS, OIG and
has been recognized as a leading law      as the optimal environment for            related agency compliance and
firm for corporate and M&A work by        discovery work, with industry-leading     litigation. Nine members of the
both The Legal 500 and Chambers           resources, technology and proven          practice have previously served in the
USA. Mergermarket also ranked us in       protocols.                                FDA, including in the Office of Chief
the top 10 among law firms by deal                                                  Counsel, the Office of Drug Policy,
volume for U.S.-based biotechnology                                                 CDRH’s Office of Compliance, the
M&A transactions.                                                                   Office of Device Evaluation, and
                                                                                    medical, regulatory and quality
                                                                                    systems experts. Our team prides
                                                                                    itself on providing thoughtful, cre-
                                                                                    ative, business-savvy and, above all,
                                                                                    legally sound solutions for our life
                                                                                    sciences clients.




                                          In Corporate Counsel’s annual
                                          survey “Who Represents America’s
                                          Biggest Companies?” King &
                                          Spalding consistently ranks among
                                          the top firms for intellectual
                                          property and litigation.
                                                                                                                      05
King & Spalding’s pharmaceutical, biotechnology
and medical device practice “is increasingly perceived
as a viable destination for important litigation and
a practice that ‘can be relied upon to handle very
significant matters.’ ‘Excellent judgment’ and a
‘proactive and pragmatic’ demeanor are among the
qualities that appeal to clients, who also highlight the
group’s ‘good value’ as another plus.”
– The Legal 500
Government Advocacy                      Healthcare                                 Intellectual Property
& Public Policy                          King & Spalding’s healthcare practice      In IP Law & Business magazine’s
The members of King & Spalding’s         serves the entire spectrum of institu-     annual survey of the country’s top 50
government advocacy & public policy      tional providers, practitioners, payors,   most innovative companies, King &
team leverage their decades of experi-   educators, researchers, inventors,         Spalding was recognized as one of the
ence working with the House, the         suppliers, investors and manufactu-        law firms most frequently mentioned
Senate and executive agencies and        rers. Our lawyers, scientists, policy      as legal counsel on intellectual
their key policymakers to help clients   analysts and consultants hold or           property matters. Nearly half of the
effectively manage their interactions    have held leadership positions in the      more than 100 members of our
with the federal government, includ-     industry and the U.S. government.          intellectual property team — many
ing federal legislation, regulation,     We count among our lawyers two             holding PhDs and other advanced
congressional oversight and investiga-   past presidents, two directors and         degrees in scientific disciplines —
tions, campaign finance and reim-        the current president of the American      devote a significant part of their
bursement issues. In addition to         Health Lawyers Association, and a          practices to the pharmaceutical,
direct advocacy before Congress and      director of the Health Care                biotechnology and medical
executive agencies, the team assists     Compliance Association In 2010, the        technology industries. Clients turn to
clients in effectively responding to     American Health Lawyers Association        us for assistance in developing
congressional inquiries, an area in      ranked King & Spalding’s health law        portfolios, negotiating and evaluating
which Chambers USA has noted that        practice the largest in the United         licensing and investment
the firm “is particularly prominent.”    States, with 234 health industry           opportunities, and litigating to
Our team of professionals is led by      practitioners, for the fourth consecu-     protect technology, products and
former congressional investigators       tive year. Chambers USA has ranked         rights. Our patent litigation
and lawyers with decades of experi-      37 of our healthcare lawyers among         experience over the past 10 years
ence in handling the unique and          the nation’s best, The Guide to the        includes more than 100 cases tried to
difficult issues — and risks — that      Leading U.S. Healthcare Lawyers            verdict, including jury and bench
confront individuals and corporations    includes nine members of our health-       trials; over 100 appellate cases
facing congressional investigative       care group, and Nightingale’s              argued, including one patent case
scrutiny. Lawyers on the team include    Healthcare News has recognized 19 of       argued to the U.S. Supreme Court;
the former U.S. chief of protocol to     our lawyers as among the top practi-       over 500 cases settled favorably prior
President Lyndon Johnson, a former       tioners in the U.S.                        to trial; over 200 cases decided on
general counsel of the House of                                                     summary judgment; and over 60
Representatives and chief of staff to                                               disputes resolved through arbitration,
the Speaker of the House, the former                                                mediation or proceedings in
staff director and general counsel of                                               administrative tribunals.
the House Rules Committee, the
former staff director of the Senate’s
Permanent Subcommittee on
Investigations, the former staff
director of the joint congressional
inquiry on the terrorist attacks of
September 11, 2001, and a former
senior investigative counsel to the
chairman of the Senate Committee
on Finance.




                                                                                                                      07
International Arbitration                    Products Liability/Mass Tort                 Special Matters/Government
Winner of a Chambers USA Award for           With more than 100 lawyers, our              Investigations
Excellence in 2010 and recognized by         product liability practice is consis-        Our government investigations
Focus Europe, The Global Arbitration         tently recognized as one of the best in      practice includes more than 40
Review and Chambers USA as one of            the nation by The American Lawyer,           lawyers in three offices dedicated
the best in the world, our international     The Legal 500, the National Law              full-time to criminal and civil investi-
arbitration practice offers our              Journal and Chambers USA, which              gations and related pharmaceutical
pharmaceutical, biotechnology and            noted our achievements on behalf of          litigation, including the former DOJ
medical device clients a full range of       clients in the pharmaceutical industry.      assistant attorney general in charge of
advice concerning the protections            Clients tell us that several character-      the Criminal Division, more than a
and remedies afforded by commercial          istics differentiate us from other           dozen former federal prosecutors,
agreements and international treaties,       firms. First, we have a deep bench of        congressional investigators and other
and, where appropriate, assembles            lead trial lawyers who try cases every       enforcement officials, as well as
the best team of advocates and subject       year. In fact, we are one of very few        lawyers who have devoted their entire
matter experts to pursue or defend           firms in the country to have tried           careers to white-collar criminal
claims related to intellectual property      class action lawsuits to verdict.            defense, congressional investigations
disputes, international licensing and        Second, as a result of our ability and       and related civil and qui tam litiga-
distribution arrangements and cross-         willingness to go to trial, we bring a       tion. These lawyers have decades of
border investments. Our lawyers have         strategic focus that is often missing in     collective experience in representing
been involved in arbitrations and            litigation. This includes expertise in       healthcare, pharmacy, PBM, pharma-
litigations involving parties or projects    identifying and preparing medical            ceutical, biotechnology and medical
across six continents, and they have         and scientific expert witnesses, as well     device companies in every phase of
handled arbitrations under the rules         as strategically attacking plaintiffs’       government investigations and ad-
of every major arbitral institution as       experts on Daubert grounds, and              ministrative matters, including those
well as under ad hoc rules. With a           working closely with our off-site            convened by state, federal and
multicultural group of international         Discovery Center in providing state-         Congressional entities, including
lawyers trained in both common law           of-the-art litigation support capabilities   DEA, DOJ, FDA, FTC, HHS-OIG,
and civil law systems and fluent in          to alleviate the burden of e-discovery.      SEC, state attorneys general,
more than 12 languages, we are able          And finally, we take ownership of the        MFCUs, state Medicaid Integrity
to handle cases effectively and effi-        client’s problem as our own, and we          Programs and many others. We
ciently anywhere in the world.               understand the business context. We          regularly handle investigations of all
                                             serve as lead counsel in literally           types in the life sciences field, such as
Labor & Employment                           hundreds of cases filed in all 50            matters regarding alleged “off-label”
King & Spalding was identified as a          states, and our clients feel comfort-        promotion, unlawful inducements,
“go-to” law firm for Labor &                 able putting King & Spalding lawyers         and other sales, marketing and devel-
Employment on Corporate Counsel’s            forward as the face of their companies.      opment activities in jurisdictions
“Go-To Law Firm” list and has been           In fact, according to Chambers USA,          throughout the country. Our expertise
recognized by Chambers USA for its           sources describe the practice as “a          extends to international and global
“excellent service and impressively          team of vigorous advocates with              investigations as well, and we have
high success rate.” Our partners have        excellent judgment who are dedicated         conducted Foreign Corrupt Practices
represented clients in the pharmaceuti-      and responsive.”                             Act investigations in many countries
cal and biotechnology industries for                                                      throughout the world. Clients in the
decades, including state and federal                                                      2010 U.S. News/Best Lawyers survey
court litigation involving equal employ-                                                  said that this practice group is “out-
ment opportunity laws, whistle-blower                                                     standing,” that it “consistently deliv-
retaliation claims, restrictive covenants,                                                ers superb legal services” and that
trade secrets, wage and hour, and                                                         King & Spalding is the “premier firm
compensation and benefits issues. On                                                      in this practice area.” Our individual
the counseling side, our service to                                                       lawyers include members of the
employers ranges from preventive                                                          American College of Trial Lawyers
advice and training to formulating and                                                    and have been singled out by
implementing diversity programs and                                                       Chambers USA and The Best Lawyers
affirmative action plans. Collectively,                                                   in America as among the nation’s best.
our employment litigators, two of
whom are members of the American
College of Employment Lawyers, have
tried hundreds of jury cases and
arbitrations and defended dozens of
class and collective actions.


08 Serving the Life Sciences Industry
Practice Highlights
More than 150 King & Spalding lawyers and non-
lawyer professionals devote all or a majority of their
time servicing life sciences companies.
We represent more than 200                 King & Spalding’s team of
pharmaceutical, biotechnology and          pharmaceutical-focused litigators
medical device manufacturers on            includes five members of the American
litigation, intellectual property,         College of Trial Lawyers, the former
regulatory and corporate matters,          solicitor general of the United States,
including 8 of the top 10, 15 of the       the former assistant attorney general
top 20, and 18 of the top 25               in charge of the Criminal Division, the
pharmaceutical/biotechnology               former acting assistant attorney
manufacturers as well as 8 of the top      general of the Civil Division, a former
10 and 12 of the top 20 medical            deputy assistant attorney general with
device manufacturers.                      responsibility for the Office of
                                           Consumer Litigation, a former
Approximately 50 of our current            associate deputy attorney general with
pharmaceutical and medical                 reponsibility for domestic and
device clients are early-stage             international drug enforcement and
R&D companies.                             drug policy, more than a dozen former
                                           U.S. attorneys, assistant U.S. attorneys
Nearly 20 percent of the firm’s top 50     and other DOJ trial attorneys, two
clients are FDA-regulated                  members of the American College of
pharmaceutical and medical device          Employment Lawyers, and the current
companies.                                 chairman of the 10,000-member Food
                                           and Drug Law Institute.
We leverage the expertise of non-
lawyer professionals (including            We have the largest health law prac-
more than 30 MDs, PhDs and                 tice in the nation, according to the
others with advanced medical,              American Health Lawyers
scientific and technical degrees) to       Association, providing additional
provide counsel and support that           depth of experience on healthcare
integrates legal, regulatory, scientific   regulatory and litigation issues.
and technical expertise.
                                           Our lawyers and professionals share
                                           important industry developments with
                                           our clients through substantive pro-
                                           grams and communications, including
                                           K&S Pharmaceutical University, the
                                           K&S Medical Device Summit and
                                           frequent webinars and electronic alerts.




                                           Chambers USA has ranked 42
                                           lawyers from our pharmaceutical,
                                           biotechnology and medical device
                                           industry practice as among the
                                           nation’s best.
                                                                                      09
Representative Matters
King & Spalding lawyers work together across practice
groups to serve clients’ comprehensive business and
legal needs. The following matters highlight our inter-
disciplinary approach to client service while representing
only a small portion of our expertise.

The firm’s litigation & antitrust and       The firm represented a large bio-          For nearly a decade, we have served
FDA & life sciences practices have          pharmaceutical company in                  as lead national counsel to
worked closely together for many            connection with the formation of a         GlaxoSmithKline (GSK) in
years in defense of a top five              new subsidiary to perform all of the       litigation and related matters
pharmaceutical manufacturer in              parent’s sales and marketing func-         involving the antidepressant Paxil®,
the multi-jurisdiction Average              tions, including contracting, order        including defending the company in
Wholesale Price cases. The combina-         management and rebate administra-          multi-district proceedings pending in
tion of expert litigation strategy, savvy   tion. Our M&A/corporate lawyers            California and Pennsylvania and
tactical judgment and substantive drug      worked closely with the client to          individual suits throughout the
pricing and distribution support permit     create the corporate foundation of the     country, and responding to
King & Spalding to provide world-           new subsidiary and advised on the          government investigations at the state
class litigation defense in even the        asset transfers necessary to complete      and national levels. We have provided
most specialized areas of risk faced by     the reorganization. The asset transfers    comprehensive legal services to GSK
pharmaceutical manufacturers.               required that our lawyers, relying in      by utilizing a broad team of lawyers
                                            part on the cost-effective resources of    that spans many practice areas,
We represented Allergan, Inc., in           our Discovery Center, review and           including product liability,
connection with a Department of             evaluate more than 10,000 customer         commercial disputes, FDA & life
Justice (DOJ) investigation of the          contracts to provide guidance regard-      sciences, government advocacy and
company’s sales and marketing of            ing assignment and novation. Our           Congressional investigations.
Botox®. King & Spalding lawyers             FDA & life sciences attorneys devel-       Attorneys in every one of King &
from the special matters, business          oped regulatory strategies to mini-        Spalding’s U.S. offices have played
litigation and FDA & life sciences          mize the government pricing implica-       significant roles in representing GSK.
groups led the company’s defense            tions of the creation of the subsidiary,   In addition to our work related to
and negotiated a global resolution of       and our IP lawyers worked with the         Paxil, we advise GSK on FDA
DOJ’s criminal investigation, civil         client to provide the new subsidiary       matters, defend GSK in commercial
claims under the False Claims Act           with the intellectual property rights      litigation and employment
and related whistle-blower actions          necessary for it to conduct the            discrimination cases, and provide
filed in federal district court. Lawyers    company’s sales operations.                counsel on corporate transactions.
in the appellate litigation group also
represented Allergan in a declaratory
judgment action filed in federal court
in Washington, D.C., against the
government, challenging FDA
regulations that prohibit truthful,
non-misleading speech about off-
label uses of FDA-approved
prescription drugs. Allergan’s
declaratory action was the first
serious challenge in more than a
decade to the government’s
enforcement position criminalizing
such speech.




10 Serving the Life Sciences Industry
We represented Ortho-McNeil-             King & Spalding represented Purdue         We have been representing a major
Janssen Pharmaceuticals, Inc.            Pharma in connection with congres-         branded pharmaceutical com-
(OMJPI), a subsidiary of Johnson &       sional investigations into the abuse       pany in multiple patent litigations in
Johnson, in a high-profile               and diversion of the company’s pain        Delaware, New Jersey and North
investigation conducted by the           medication, OxyContin®. Lawyers            Carolina federal district courts
Department of Justice, the U.S.          and consultants in our government          including two Paragraph IV Hatch-
Attorney’s Office in Boston and          advocacy, special matters, products        Waxman challenges to a patented
various other state attorneys general    liability and FDA & life sciences          drug delivery system for an anesthetic
into the company’s sales and             groups represented Purdue in connec-       agent, and a lawsuit and correspond-
marketing practices of one of its        tion with the investigations and           ing reexamination proceedings
pharmaceutical products, Topamax®.       hearings conducted by five separate        relating to method patents for blood
We successfully negotiated a global      congressional committees, as well as a     plasma screening. These patent
settlement with federal and state        two-year investigation by the              litigation matters have involved
regulators, which included handling      Government Accountability Office,          substantial collaboration of our
the company’s Corporate Integrity        which culminated in a December             patent litigation, FDA/regulatory
Agreement with the inspector general     2003 report. In addition, lawyers in       and antitrust teams.
of the U.S. Department of Health         our products liability group have
and Human Services while federal         served as national coordinating            A cross-practice team of King &
sunshine legislation became effective.   co-counsel and lead trial counsel to       Spalding lawyers represented a
We also successfully negotiated          Purdue Pharma in litigation involving      European drug manufacturer in an
Medicaid claims by the 50 states and     the pain medication OxyContin and          international arbitration under the
the District of Columbia. We             related civil and criminal investiga-      World Intellectual Property
resolved the matter globally in 2010     tions. Our lawyers have obtained           Organization Rules. King & Spalding’s
for approximately $81.5 million,         407 dismissals, including 27 orders        client licensed its rights to an estab-
which extinguished the company’s         granting summary judgment, and             lished drug to a U.S.-based company.
criminal liability and civil False       have defeated 15 class actions. The        The Licensee was required to conduct
Claims Act exposure and allowed the      firm also serves as liaison for Purdue’s   clinical trials and then seek approval
company to continue participating in     coordinated defense with Abbott,           from the U.S. FDA to use the drug for
federal programs. The matter             which co-promoted OxyContin.               a new indication. The licensee failed to
combined the expertise of our special                                               achieve FDA approval. The firm’s
matters/government investigations,       We represented UCB Pharma, Inc.,           FDA & life sciences group led an
FDA & life sciences, business and        in the formation of a worldwide            investigation into the licensee’s con-
appellate litigation, and government     alliance that gave Shire                   duct of the clinical trials to determine
advocacy & public policy practice        Pharmaceuticals the right to promote       why they failed. Following that investi-
groups to provide comprehensive          and commercialize the use of               gation, the case was settled on favor-
counseling and strategic direction       EquasymTM outside the United States        able terms.
through one interactive team.            and Canada. Our M&A/corporate
                                         lawyers worked with UCB on the
                                         transfer of UCB’s Equasym product
                                         rights and related intellectual property
                                         rights to Shire. Our M&A corporate
                                         lawyers also advised UCB on the
                                         supply arrangements between UCB
                                         and Shire for Equasym. Our IP
                                         lawyers advised UCB on the terms of
                                         the license from UCB to Shire of
                                         UCB’s patent, trademark and know-
                                         how rights related to Equasym. Our
                                         FDA/regulatory lawyers advised UCB
                                         on regulations and other laws in the
                                         United States and the EU that applied
                                         to the transaction and assisted UCB
                                         in negotiating the regulatory terms of
                                         the transaction agreements.




                                                                                                                        11
Representative            Adolor Corporation
                          Alfa Wasserman
                                                              Macrogenics
                                                              MedImmune
Clients                   Allergan
                          Alpharma
                                                              Medtronic
                                                              Merck
                          Amgen                               Merial
                          Astellas                            N30 Pharmaceuticals
                          AstraZeneca                         NVS Technologies
                          Baxter Healthcare                   Nektar Therapeutics
                          Becton-Dickinson                    New York University
                          BioMarin                            Novo Nordisk
                          Boehringer Ingelheim                PerkinElmer
                          CVS Caremark                        PharmaMar
                          Cardinal Health                     PsychoGenics
                          Care Capital                        Purdue Pharma
                          Celgene                             Quidel Corporation
                          Columbia University Science and     Regado Biosciences
                            Technology Ventures               Revance Therapeutics
                          Corium International                Revivicor
                          Cornell Research Foundation         Roche/Genentech
                          Daiichi Sankyo                      sanofi-aventis
                          Danco Laboratories                  Salutria
                          Defibtech                           Schering-Plough
                          Depomed                             Shire Pharmaceuticals
                          Dornier MedTech                     Smith & Nephew
                          Dow Chemical                        Stem CentRx
                          Drug Royalty Corporation            Stryker
                          Edwards Lifesciences                Sunovian
                          Eisai                               Theragenics
                          Eli Lilly                           UCB Pharma
                          EMD Serono                          University of Dublin
                          Emory University                    University of Wyoming
                          Enzo Biochem                        Vivus
                          GE Healthcare                       Zimmer
                          Genzyme
                          Georgia Tech Research Corporation
                          GlaxoSmithKline
                          Hikma Pharmaceutical Company
                          Immucor
                          Jazz Pharmaceuticals
                          Johnson & Johnson
                          Kinetic Concepts USA, Inc. (KCI)
                          Lumos Pharmaceuticals




12 Serving the Life Sciences Industry
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