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JEAN W. FRYDMAN, ESQ.

10 Old Fort Road * Bernardsville, NJ 07924


Home: 908.766.1718 * Cell: 908.285.0882 * Fax: 908.766.1746
jfb04dae@westpost.net

PROFILE
General Counsel of both private and publicly held companies with extensive exper
ience managing complex litigation, corporate disclosure obligations, regulatory
compliance, and commercial transactions including M&A, licensing and supply agre
ements. Develop and manage compliance programs and policies for large and start
-up pharmaceutical/medical device organizations as Chief Compliance Officer. Ma
nage internal and outside legal counsel on intellectual property, securities and
finance matters. Advise board members on securities law and corporate governan
ce.
PROFESSIONAL EXPERIENCE
FERRING PHARMACEUTICALS, INC., Parsippany, NJ 2007 - present
U.S. General Counsel, Secretary and Chief Compliance Officer
Responsible for all legal matters supporting the U.S. business of approximately
265mm in sales. Have additional responsibility as Chief Compliance Officer and
building a compliance program from ground up. Manage a legal staff of six (6).

* Successfully created a Compliance Risk Committee for the US Board. As Chairma


n of this committee, I minimize the company's overall risk in product liability,
anti-trust and corporate compliance, by advising on overall company strategies.
* Established good corporate governance as the Chief Legal Officer and Corporate
Secretary for all four US subsidiaries, by providing consistency and accountabi
lity for all entities.
* Negotiated favorable settlements on all potential HR litigation matters preven
ting considerable liability for the company. As a result, authored and rolled ou
t necessary key policies to address any further potential HR liabilities.
* Minimized government enforcement by establishing critical legal/ regulatory kn
owledge to employees by conducting training on False Claims Act, anti-kickback s
tatutes, HIPAA, off-label promotion, Stark and Medicare and Medicaid conditions
of participation.
* Penetrated customer base by drafting and negotiating several product acquisiti
ons and licensing agreements. One such acquisition provided the customer base ne
eded for several new drug entities developed and marketed by the company.
* Prevented loss of critical clinical multi-site trial by litigation settlements
with several plantiffs for lack of payments. Prevented $5M liability in rebate
payments for the company on a managed care arbitration settlement.
* Enhanced Company's efficiency in regulatory performance and monitoring by coor
dinating the creation and implementation of internal compliance tracking systems
.
* Conducted fraud and abuse training for senior executives and sales representat
ives.
NOVADEL PHARMA INC., Flemington, NJ 2004-2006
Vice President, General Counsel & Corporate Secretary
Responsible for all legal matters of the company which included: HR and employm
ent, Patent Prosecution & Protection, drafting and execution of development and
licensing agreements, regulatory matters with the SEC, FDA,OIG, EPA, DEA and CMS
. Provided legal risk assessments on all matters including litigation. Advised
and assisted Chief Executive Officer and Chief Financial Officer on SEC filings
, SOX Compliance, private placements and proxy statements. Participated with ma
nagement on all strategic business initiatives. As Corporate Secretary, assured
compliance with AMEX, SEC and Delaware Law regulations. Maintained all records
of the Corporation and the Board of Directors. Primary contact for compliance
Hotline, reporting violations, as necessary, to the Audit Committee.
* Strategized with FDA and potential innovator company to avoid patent litigatio
n for company's first 505b (2) submission to FDA.
* Revamped the company's existing option and warrant agreements to prevent any S
EC violations and negotiated a seamless transfer of those agreements with SEC.
* Negotiated major licensing agreements bringing in large milestone payments; a
double-digit royalty stream.
* Efficiently provided legal coverage, laying the groundwork for force reduction
required in 2005.
* Authored and implemented a comprehensive compliance program for the company, i
ncluding Code of Business Conduct, Code of Ethics and charters for the board.

PFIZER INC., Peapack, NJ 1999-2004


(2003-2004-Pfizer)
(2000-2003-Pharmacia)
(1999-2000-G. D. Searle)
Associate General Counsel
Provided general legal support for oncology, women's health, cardiovascular and
ophthalmology franchises, primarily promotional/regulatory review, drafting comm
ercial contracts, and general litigation support and IP life cycle matters. Maj
or products included Caduet(R), Celebrex(R), Camptosar(R), DepoProvera(R), Healo
n(R) and CeeOn Lenses. Reviewed Company-sponsored CME and Symposium programs.
Developed and wrote company promotional policy and trained appropriate personnel
. Opined on programs as they related to fraud and abuse and anti-kickback issue
s. Prepared risk analyses on FDA, DEA and FTC and SEC compliance matters. Serv
ed on several PhRMA law committees. Received "On The Spot Award" for ability to
analyze a complex and very serious manufacturing compliance problem and executin
g resolution by coordinating both internal and external legal support. Prevente
d the shut-down of three manufacturing plants generating multi-billion dollar pr
oducts.
* Established Ethics and Compliance Guidelines for US and selective internationa
l locations. Authored two distinct Ethics and Compliance policies; one for the
US customers (physicians and hospitals), the other for institutional (large phar
maceutical buying wholesalers).
* Organized and served on multi-discipline pricing committee dealing with potent
ial anti-kickback, and fraud and abuse issues.
* Lead counsel for strategic planning and review of launch materials for company
's greater than $1 billion sales product, Caduet(R).
* Promoted twice within five years, with added legal responsibilities, by succee
ding in both line management and staff roles.
* Lead attorney assigned by General Counsel to manage significant crisis managem
ent issues relative to hormone replacement and oncology products.
BASF CORPORATION, Mt. Olive, NJ 1996-1999
Senior Attorney, Product and Trade Regulations
Primary responsibility was servicing the Knoll Pharmaceutical Division. Advised
, reviewed and opined on all advertising materials for all drug products interfa
cing with FDA and FTC. As part of these responsibilities, analyzed regulatory s
trategies for pre-38 DESI drug. Reviewed clinical investigator supplier contrac
ts and risk analysis on all FDA compliance matters. Provided strategic regulato
ry support for diagnostic products marketed with the drug products. Served on P
hRMA Law Committee. Also provided legal counsel to company's Agriculture Divisi
on on FIFRA registrations and prosecuted applications under Toxic Substances Con
trol Act (TSCA) for the Chemical Division.
* Chosen as critical member of a crisis team for a $6.2 billion class action sui
t.
* Lead counsel to receive FDA approval for television advertisement for first co
ntrolled substance, Meridia(R); also regulated by DEA.
PHARMACIA, INC., Columbus, OH (Later became Pharmacia & Upjohn) 1994-1996
Legal/Regulatory Director
In this position, had responsibility for all regulatory functions for the Diagno
stics and Ophthalmic Divisions. Responsible for all regulatory issues for Pharm
acia, Inc., when interfacing with the FDA on submissions for approval and for al
l matters of compliance. Implemented regulatory strategies for expeditious FDA
approval with United States organization and with Sweden organization. Drafted
due diligence and clinical investigator agreements. Designed, reviewed and impl
emented quality systems to meet GMP requirements for all US facilities and all f
acilities in Sweden.
FENWICK & WEST, Washington, D.C. 1992-1994
Corporate Healthcare Attorney
For this 150-plus multi-office corporate law firm, advised clients on regulatory
strategies for submitting applications to the FDA while minimizing potential pr
oduct liability problems for clients. Represented scientific companies that pro
duced medical devices, biopharmaceuticals, in-vitro diagnostics, foods, vaccines
and blood products. Examined the law and presented findings to Bio-conferences
on current legislative issues affecting biotechnology companies. Conducted due
diligence for corporate mergers; analyzed corporate documents for IPOs, mergers
and acquisitions; drafted corporate and stockholder agreements. Prosecuted app
lications under TSCA.

ABBOTT LABORATORIES, Abbott Park, IL. 1982-1992


Regulatory Attorney (1990-1992)
Implemented legal strategies to obtain export licenses for HIV-1 products. Aide
d Canada in resolving regulatory barriers. Diminished risk to Japanese import r
estrictions through Moss Negotiations in Washington DC. Registered and maintain
ed registrations for all diagnostic products registered in international markets
during changing regulatory climates. Served on several task forces for HIMA in
Washington DC, representing Abbott Laboratories.
Senior Regulatory Specialist (1989-1990)
Negotiated key approvals from the FDA for the Infectious Disease Diagnostic Busi
ness Unit and Physiological Diagnostic Business Unit. Developed and maintained
computer tracking system for submission filing purposes. Lifted import regulati
ons restricting imports into Australia. Responsible for all international regis
trations for diagnostic products (approximately $3 billion in sales).
Regulatory Specialist for Diagnostic Products 1983-1989
Designed and implemented a computer tracking system for ADD submissions and appr
ovals. Developed an international "data package" for worldwide submissions. Pr
epared and executed FDA submissions for infectious disease diagnostic products.
Developed an instructional operational manual for internal registrations. Pres
ented extensive training workshops on International Registration requirements th
roughout the Diagnostic Division staff. Assisted with conducting plant inspecti
ons and audits.
Quality Control Technician in Hepatitis (1982-1983)
Implemented a system for record keeping of master lot components. Team member o
n the Auszyme II Modified Project with responsibility for testing and quality co
ntrol documentation and for standardizing control procedures.
VARIOUS SCIENCE POSITIONS 1975-1977
Medical Technologist (further information upon request)
OTHER RELATED ACTIVITIES
LEGAL CONSULTANT 2006-2007
Provided legal advice and strategy on complex regulatory matters for such compan
ies as Bristol-Myers Squibb, Reliant Pharmaceuticals, Cephalon and Abbott Labora
tories. Advised and coordinated such matters with multi-disciplinary teams, in
such areas as reimbursement, promotional review, anti-kickback, and SOX, as well
as contractual matters and litigation affecting those companies' franchises. S
erved as interim monitor for SEC on a pharmaceutical acquisition.
SETON HALL LAW SCHOOL, Newark, NJ 2004-2006
Adjunct Professor (Evening Classes)
EDUCATION
Juris Doctorate Degree, CHICAGO-KENT COLLEGE OF LAW, Chicago IL
Master of Arts Degree, CENTRAL MICHIGAN UNIVERSITY, Mt. Pleasant, Michigan
Hospital and Healthcare Administration - Summa Cum Laude
Bachelor of Science Degree, OHIO STATE UNIVERSITY, Columbus, OH
Allied Health Professions - School of Medical Technology
Professional License: ASCP#MT101519
PROFESSIONAL AFFILIATIONS
American Bar Association
American Corporate Counsel Association
General Counsel Roundtable
Corporate Secretary
Pharmaceutical Compliance Forum
Food and Drug Committee for New Jersey Corporate Counsel - Chair, 1997, 1998, 20
01-Present
Frequent Speaker for ALM Conferences, General Counsel Institute, National Associ
ation of Women Lawyers
Trustee, Board for Resource Center for Women & Children, Somerset County