Sales Real Estate

ELONA KOGAN, ESQ.

Licensure: DC & CA 917-***-**** (c)

KING PHARMACEUTICALS, INC. - Bridgewater, NJ 2005 to Present

Associate General Counsel & Privacy Officer

Develop and manage commercial operation initiatives regarding

pharmaceutical marketing with significant emphasis on OIG, PhRMA Code, FDA

advertising regulations and state marketing disclosure law tracking and

reporting. Responsible for developing and presenting educational programs

to marketing, sales, and managed markets, on educational grants and CIAs,

in connection with settlement agreements. Responsibilities include:

. Fraud and abuse & FDA/Promotional Compliance: overseeing sales and

marketing functions for drugs and devices, responsible for developing

and implementing policies & procedures on incentive compensation,

grants (CME & Research) (for U.S., and Canada), consultant matters (for

U.S., and Canada), gift issues, coupons, social media policies; and

compliance with FDA rules and regulations on promotional compliance.

. Scientific Operations: advising on trial issues: patient enrollment, PI

recruitment, incentives, phase IV trials for controlled substances and

non-controlled substances, pediatric exclusivity issues; providing

legal counsel for labeling submissions; advising on pharmacovigilance

matters as they relate to product liability issues. Preparing and

responding to citizen petition filings.

. State Marketing Disclosures: responsible for establishing cross-

functional approach to implementing and maintaining systems and

policies to ensure accurate and timely marketing reporting compliance,

and advising stakeholders on legislative developments.

. Privacy Issues: responsible for developing and implementing compliance

with privacy policies (telemarketing, facsimile, opt-in/opt-out issues;

security, data sharing for U.S., and Canada), cross-border data

transfers.

. Contracting (for U.S., and Canada), advising on in-licensing

agreements, advertising agency, TM & master services agreements,

speaker & consultant agreements, analysis of needs assessments, FMV

issues, PhRMA Code compliance, AdvaMed, Rx&D, and MEDEC.

. Litigation: assessing & managing litigation on issues ranging from

product liability, libel, slander, unfair practices, and Lanham Act

violations; Responsible for DOJ investigation and resolution.

. Corporate Governance Matters: reviewing and advising on SEC filings

including, press releases 10Q, 10K, 8Q; preparing and presenting board

presentations (e.g., DOJ matters).

ARENT FOX - NY, NY

2005

Health Care Practice/Transactional/Regulatory

Supported hospital systems, physician associations and health care

providers on legal issues involving fraud & abuse, EMTALA, HIPAA, corporate

practice of medicine, FDA, and managed care contracting issues.

BRISTOL-MYERS SQUIBB - Plainsboro, NJ 2003 to 2005

U.S. Medicines

Supported major pharmaceutical brand product on all legal issues including

contracting, FDA issues, and promotional compliance. Supported managed care

contracting organization. Advised on Medicare and Medicaid issues.

Responsible for implementing and maintaining grant making function policies

and procedures. Engagements and work included:

. Health/Corporate: negotiated and drafted managed care agreements and

rebate agreements, drafted and negotiated IITs, advised on PDMA issues;

responsible for issues pertaining to MMA drug discount card

contracting, worked closely with senior management to develop MMA

contracting policy, prepared RFPs, and MMA contracts; involved in

Together Rx ("TRx"), participated in PhRMA Legal Committee work stream

on TRx; analyzed; Fraud and abuse: worked closely with

medical affairs, consultant matters, gift issues, coupons, supported

sales and marketing functions, analyzed new sales aids, maintained

committee participation.

. Patient Assistance Program: primary responsibility for matters relating

to the operation of the BMS Patient Assistance Foundation including

operations, privacy, inurement/private benefit, charitable donations,

and fraud and abuse issues.

CBD L.P. - New York, NY

2001 to 2003

Counsel/Director of Business Development

Practiced general corporate and real estate law, responsibilities included:

drafting documents pertaining to domestic and international corporate

transactions; negotiating, reviewing, revising and drafting IT agreements,

distribution agreements, licensing agreements, confidentiality and

employment agreements; performed due diligence reviews; maintained

corporate governance documents; and supervised outside legal counsel.

BERGEN BRUNSWIG CORPORATION - Orange, CA

2000 to 2001

Counsel

Represented Fortune 200 Company in matters of pharmaceutical regulatory

compliance: reviewed, revised and drafted GPO agreements; drafted leases,

licensing agreements, web site development agreements, upgrading and

monitoring agreements and NDAs. Analyzed 340B issues. Analyzed transactions

for fraud and abuse implications. Responsible for the purchase and sale of

real estate, closings, and regulatory compliance.

EPSTEIN BECKER & GREEN - Los Angeles, CA

1994 to 1999

Corporate/Health Care Department Associate

Represented health care delivery systems and providers, including

hospitals, MCOs, medical groups, PMCs and other health care entities.

Researched, analyzed and wrote legal opinions on issues pertaining to fraud

and abuse, Stark, Medicare/Medicaid Anti-Kickback, EMTALA, HIPAA, and

corporate practice of medicine issues. Drafted corporate compliance plans.

Analyzed provider contracting issues, medical staff issues and general

business, operational and regulatory matters.

THE HONORABLE RONALD S. W. LEW - Los Angeles, CA

1994

Federal District Court Intern

Researched issues of law, prepared memoranda and participated in bench

discussions.

EDUCATION

J.D. - Southwestern University School of Law - American Jurisprudence

Award in Corporations

BA, Major - Economics; Columbia University - Cum Laude

PUBLICATIONS

Co-authored with Mark A. Kadzielski, Esq., "Are You Practicing Medicine?"

California Medicine, 1998; "Physician and Allied Health Professional

Credentialing," American Society for Healthcare Risk Management Handbook,

1997; "Provider Deselection and Decapitation in a Changing Healthcare

Environment," 41 St. Louis L.J 891, Summer 1997

MEMBERSHIPS, PUBLIC SPEAKING, LICENSURE, FOREIGN LANGUAGE & AWARDS

AHLA, Los Angeles County Bar Association, Women Lawyers Association of

Los Angeles, AABC; Fellowship Committee, President, Barnard College

Alumni Association of Los Angeles; Beverly Hills Meals on Wheels; Spot

Award Recipient - BMS Medicare Initiative

ACI - Invited Speaker: "State Enforcement - Picking Up Where the Federal

Government Left Off: The States' Growing Interest in Regulating Drug

Promotion"

iiBIG - Invited Speaker: "NEXT GENERATION PHARMA SALES & MARKETING

SUMMIT: Staying Ahead of the Curve in an Ever-Changing World"

Annual Pharmaceutical Compliance Conference - Invited Speaker:

"Regulatory Review Period - Examining the Legal and Regulatory Landscape

to Minimize the Risk in Pre-Approval Communications"

Fluent in Russian

Recipient of the 2010 Pharmaceutical Executive Emerging Leader Award

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