Management Commercial

Stephen Cipolla

Email: *********@********.***

Address: *** ******** ***.

City: Wyncote

State: PA

Zip: 19095

Country: USA

Phone: 215-***-****

Skill Level: Senior

Salary Range: $150,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Stephen J. Cipolla, Attorney at Law

215-***-**** (home) 267-***-**** (mobile)

*********@*****.***

Strong, experienced leader and compliance counselor in commercial law, expertise in all aspects of antitrust, pricing, reimbursement, competition, and commercial regulation of the pharmaceutical industry. Developer of risk-reducing business strategies and legal compliance programs that enhance awareness of legal, regulatory and ethical issues.

EXPERIENCE

Cipolla Associates, LLC, Jenkintown, PA February 2012--Current

Partner

Counsel in broad variety of commercial legal areas, including compliance, contracts, antitrust, pricing, litigation, and marketing strategy. Assist individuals, businesses and entrepreneurs in developing winning negotiation strategies in transactions and disputes.

Merck & Co., Inc., Upper Gwynedd and West Point, PA 1991 - 2011

Counsel II, Office of General Counsel (2005 - 2011)

Leader of US commercial litigation; settlement, trial and appellate strategist; legal oversight of pricing / reimbursement practices; lead antitrust counsel for all US business.

Legal supervision of US pricing / reimbursement / discount practices and policies with public and private payers. Legal support for Merck Vaccine Division pricing.

Led legal team tasked to revise global compliance programs. Revised Merck Antitrust Compliance Policy. Drafted compliance materials relating to antitrust, anti-kickback, privacy, pricing and reimbursement, interactions with joint ventures, collaborations with third parties, ethical business practices.

Instructed pharmaceutical antitrust curriculum to Merck US-based commercial lawyers.

Negotiated several favorable settlements in complex, multi-defendant cases, usually paying less than cost of defense.

Won major antitrust appellate decisions in Second and Eighth Circuit Courts of Appeal. Directed successful litigation strategy in major patent / antitrust litigation.

Negotiated and implemented long-term alternative billing with outside law firms reducing US litigation expenses by 20%.

Negotiated wide variety of agreements with competitors, designed effective competitive benchmarking programs, evaluated trade association membership risks, competitive intelligence gathering practices and trade secret protection programs.

Counsel, Office of General Counsel (2002 - 2005)

Leader of settlement strategy in major antitrust and commercial litigation; leader in comprehensive revision of inventory management, terms of trade, and product supply and distribution systems. Directed expanded compliance programs.

Negotiated highly favorable antitrust settlements by creating innovative marketing service arrangements with major retail chain plaintiffs without cash payments in return for full releases, settlements generated 3:1 ROI for Merck.

Advised Merck federal government affairs staff in formulating and discussing

Merck positions on Medicaid pricing regulations. Met with Congressional staffers on House Ways and Means Committee to discuss healthcare reform.

Expanded compliance programs to include competitive intelligence gathering, insider trading, and HIPAA.

Legal lead on award winning operations team that rationalized US commercial distribution and inventory policies and practices, increasing accuracy of predicted customer demand, capturing short and long term efficiencies and ensuring substantial, ongoing manufacturing cost savings to Merck and improved relations with major trade customers.

Won several cases alleging privacy violations against Merck, successfully defending and preserving its patient support programs.

Legal support for highly successful launch of two major JV products, Zetia and Vytorin, including development of new stocking program strategies and special wholesaler launch incentive programs.

Assistant Counsel (1995 - 2002)

Directed strategy in massive antitrust price-fixing cases; primary contact with antitrust enforcement authorities; general counsel to company joint venture operation.

Managed all domestic, commercial, non-IP litigation, developed and implemented successful settlement strategy in national class action price fixing litigation, assisted in negotiation and drafting many state and federal settlement agreements in class and individual antitrust actions, including innovative cy pres settlement in California antitrust class action.

Member of Merck negotiation team that formed Merck/Schering Plough Joint Venture (JV). Sole operational counsel for JV with legal responsibility for multi-billion dollar business. Drafted JV operating policies designed and implemented antitrust, anti-kickback and regulatory compliance programs for 200+ JV employees. Counseled JV senior managers in managed care contracting strategy. Drafted compliance guidelines for JV / parent company interactions.

Merck liaison to Federal Trade Commission, US Justice Department Antitrust Division, and state enforcement authorities in informal inquiries and responses to formal requests. Prepared Merck executives for related interviews and testimony.

Senior Attorney (1991 - 1994)

Chosen to be Merck's first in-house antitrust specialist. Created and directed customized antitrust compliance and counseling programs. Managed and directed commercial and product liability litigation.

Created and conducted ongoing company-wide antitrust / commercial legal compliance programs.

Advised senior management regarding antitrust risks of joint ventures and acquisitions, including Merck's 1993 $6.6 billion acquisition of Medco Containment Services.

Advised Merck senior marketers concerning antitrust, anti-kickback and other legal risks of managed care pricing and marketing strategies. Adopted risk reducing alternatives with minimal impact upon business value.

Member of award-winning team that negotiated Merck's first rebate agreement with Kaiser Foundation HMO.

Legal counsel to committee responsible for North American pricing all Merck on-patent and multi-source products in hospital, institutional and health system markets.

Pepper Hamilton, LLP, Philadelphia & Harrisburg, PA 1984 - 1991

Commercial Litigation Associate (1985 - 1991); Summer Associate and Law Clerk (1983-84)

Education

JD, magna cum laude, Dickinson School of Law, Carlisle, PA

Ranked fifth in graduating class of 159 students.

BA, cum laude, Pre-Civil War US History, University of Pennsylvania, Philadelphia, PA

Selected Presentations / Publications

Price Discrimination Handbook, Contributing Writer, ABA Section of Antitrust Law, January 2013

Price Discrimination Fundamentals, Corporate Counseling Committee Webinar, American Bar Association, June 2012.

Sixth Annual In-House Counsel Forum on Pharmaceutical Antitrust: Conference Co-Chair, 2011.

Pharmaceutical Antitrust Industry Handbook, Editorial Board, ABA Section of Antitrust Law, July 2009.

The Continuing Marginalization of the Robinson Patman Act, Law Seminars International, 2008.

Avoiding the Appearance of Predatory Pricing by Carefully Crafting Pricing and Distribution Strategies, 5th Annual In-House Counsel Forum on

Pharmaceutical Antitrust, 2008.

Pricing and Distribution Agreements: Maximizing Flexibility While Controlling Risk, A Comprehensive Two-Day Conference on Licensing, Life-Cycle Management, and M&A, 2008.

Pharmaceutical Product Market Definition: Counseling the Commercial Client, 3rd Annual In-House Counsel Forum on Pharmaceutical Antitrust, 2007.

Practical Approaches to Price Discrimination, In-House Counsel Forum on Pharmaceutical Antitrust, 2005

General Session: Managing Antitrust Litigation: The View From Inside, American Bar Association 51st Annual Antitrust Section Spring Meeting, April 2-4, 2003.

Memberships

Supreme Court of Pennsylvania

United States District Court for the Eastern District of Pennsylvania

United States Court of Appeals for the Third Circuit

Greater Philadelphia Senior Executives Group

American Bar Association, Section Member: Antitrust and Business

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