Medical Sales

MICHAEL J. SHEARN

Attorney at Law

P.O. Box *****6 • San Antonio, TX 78278

210-***-**** • FAX: 210-***-**** • acckcs@r.postjobfree.com

Experienced Legal Adviser

Skilled, accomplished, problem-solving, consensus-building, energetic attorney with comprehensive and extensive

experience in contracting (including distribution agreements, leases, purchase agreements, consulting contracts), commercial

and secured transactions, employment law, life sciences, healthcare, business, corporate, privacy, securities, legislation,

regulatory law, including preparation of compliance policies, compliance training, monitoring/auditing, administrative

rulemaking. Analytical skills to research and interpret complex federal and state laws and rules. Verbal and written

communication skills to advise senior management, colleagues, and employees in public and private organizations to

facilitate successful operations while managing various risks. Adaptable with reputation for strong work ethic and integrity.

Conversant in Spanish.

Accomplishments

• Prepared contractual template provisions to comply with applicable foreign and US legal and regulatory restrictions

and rules for compensated international consultants and advisers

• Managed corporate contracting processes and negotiated complex contracts, including asset purchase agreements,

merger agreements, clinical research agreements, contract research organization service agreements and building and

laboratory leases

• Created US corporate standard operating procedure (SOP) for review and approval of nonpromotional scientific,

clinical trial or medical information/materials intended for communication to individuals or audiences external to the

company that resulted in auditable documentation showing compliance with applicable federal laws and policies

• Created global SOP for electronic receipt, review and approval of unsolicited applications by potential investigator-

sponsored clinical research grants to be compliant with and auditable under federal laws and rules (OIG, FDA, DOJ)

• Drafted and implemented ethics and compliance policies and guidelines, including PhRMA Code, antikickback

statute, false claims act, and state transparency ("sunshine") laws, for US drugs and biologics sales and marketing

personnel that resulted in reduced or no noncompliant behavior and no regulatory or enforcement investigations

• Participated in review and approval of FDA-regulated product advertising/promotion materials

• Developed and presented compliance training for sales and medical affairs personnel

• Investigated, monitored, and audited corporate compliance programs to meet annual public reporting requirements

and implemented any needed individual corrective action plan

• Conducted risk assessments that identified/prioritized compliance risks to focus monitoring/auditing/training plans

• Obtained reversal by Texas Supreme Court of lower court decision under Texas Deceptive Trade Practices Act

[citation available]

• Drafted and testified for successful clarifying amendment to state merger law enacted by Texas Legislature [legislative

history available]

Licenses/Admissions/Certifications

• Supreme Court of Texas/State Bar of Texas

• District of Columbia Court of Appeals/District of Columbia Bar

• Supreme Court of United States

• Certified in Healthcare Compliance (CHC), Compliance Certification Board of Health Care Compliance Association

(HCCA)

• Certified in Healthcare Privacy Compliance (CHPC), Compliance Certification Board of HCCA

• Rated AV® Preeminent™ by LexisNexus Martindale-Hubbell Peer Review Ratings

Education

• Juris Doctorate, University of Texas School of Law

> Phi Delta Phi Honor Society; Texas International Law Journal Staff

> International Law Summer Program, British Institute of International & Comparative Law, London

• Bachelor of Arts with Honors, University of Texas at Austin

> Special Honors in Plan II Liberal Arts Honors Program; Phi Beta Kappa

> Exchange Program Scholar, La Universidad Católica, Lima, Perú

MICHAEL J. SHEARN • 210-***-**** •acckcs@r.postjobfree.com 2

Professional Experience

Regulatory Compliance Consultant & Attorney 2012 - Present

Michael Shearn, JD, CHC, CHPC, Life Sciences/Healthcare Regulatory Compliance Advisers

Advise companies on federal and state laws, regulations and guidelines affecting pharmaceutical, biotech and medical device

companies, including medical affairs, marketing and clinical research activities, FDA, anti-kickback, OIG safe harbor rules,

e.g., fair market value compensation, contracting, FCA, FCPA, PhRMA & AdvaMed Codes, and state and federal

transparency ("sunshine") reporting rules; advise healthcare providers on federal and state laws and rules, including patient

privacy (HIPAA, HITECH and informed consent), and healthcare delivery issues, e.g., CMS and Stark self-referral rules.

Senior Counsel, Compliance & Healthcare 2004 – 2012

Genzyme Corporation (acquired by Sanofi), San Antonio, TX & Cambridge, MA

Advised and trained medical affairs, marketing and sales employees (drugs, biologics, and medical devices) on legal,

regulatory (e.g., FDA), and compliance (e.g., anti-kickback, OIG safe harbor rules, FCA, FCPA); prepared guidelines,

policies, and training materials for corporate compliance program; monitored adherence to compliance program, PhRMA &

AdvaMed Codes, and conducted employee misconduct investigations, implemented corrective action, if needed; conducted

compliance risk assessments; advised on state and federal transparency ("sunshine") reporting rules; advised on clinical trial

contracts, disease registries, patient enrollment, privacy (HIPAA), and informed consent rules; reviewed, edited, and

approved medical affairs materials and product promotional information; monitored laws and regulations.

Associate General Counsel 2000 – 2004

ILEX Oncology, Inc., San Antonio, TX (acquired by Genzyme Corporation, 2004)

Advised management and provided employee training on legal, regulatory, and compliance matters, including HR/employment

law matters, biologics and drug clinical trial contracts, contract research organization service agreements (ILEX Oncology

Services, Inc.), product distribution agreements, SEC and FDA filings, lease negotiations.

Michael Shearn Attorney & Mediator 1992 – 2000

(including Of Counsel, Sessions & Sessions 1998-2000), San Antonio, TX

Represented business owners and health care providers in judicial and agency proceedings, including appeals; employment

law, including ADA and EEOC; business organizations; real estate, including acquisitions, leases and foreclosures; contracts;

commercial transactions; environmental law; certified mediator; certified Tex. Ed. Agency hearing examiner.

General Counsel 1990 – 1992

Texas National Research Laboratory Commission ( Superconducting Super Collider Projec t)

Advised Commission and senior staff on legal matters and interactions with US Department of Energy; preparation,

negotiation, and review of contracts (construction, property management, procurement, site infrastructure development,

research grants, real estate acquisition and conveyance, and lease and property use); management of representation by

outside law firms.

Shareholder, Corporate/Securities/Business Law Section 1985 – 1990

Cox & Smith Incorporated, San Antonio, TX

Areas of practice included: business, banking and commercial law; federal and state securities law; corporations; corporate

takeover defense; mergers and acquisitions; partnerships; trade secret protection; contracts; promissory notes; deeds of trust,

mortgages and security agreements; assignment of rents and leases; Uniform Commercial Code matters; letters of credit;

bank corporate trust and indenture trustee matters; international investment; copyright registration; federal/state trademark

registration; selected unfair competition and tax matters; legislation.

Shareholder, Corporate/Securities/Business Law Section 1981 – 1985

Law, Snakard & Gambill, P.C., Fort Worth, TX

Areas of practice included: business, banking and commercial law; federal and state securities law; broker-dealer and

investment adviser formation and regulation; securities underwriting and broker placement agreements; Investment

Company Act issues; mergers and acquisitions, including asset and real property sale and purchase agreements; corporations;

director, officer and shareholder liability; partnerships, joint ventures; bank corporate trust and indenture trustee matters;

real property and equipment leases; loan and security agreements; contracts; Uniform Commercial Code issues; letters of

credit; international trade and investment; administrative law; selected tax matters, including Foreign Investment in Real

Property Tax Act; franchise agreements; legislation.

MICHAEL J. SHEARN • 210-***-**** •acckcs@r.postjobfree.com 3

Associate, Surrey & Morse (now Jones Day), Washington, D.C. & New York 1976 – 1981

Areas of practice included: federal and state securities law; corporations; partnerships; international investment; Foreign

Corrupt Practices Act; federal agency administrative practice, including SEC, FDA, FTC, DOT, ITC, DOD, FEC,

Commerce, Treasury and State Departments; antitrust; legislation.

Memberships

• Ethics & Compliance Officer Assn • VP/Treasurer, Assn of Corporate Counsel, South/Central Texas chapter

• Health Care Compliance Assn (HCCA) • American Health Lawyers Assn • Regulatory Affairs Professional Society

Publications and Presentations

• Presented at national seminars on federal and state compliance law, medical science liaison best practices, investigator-

sponsored clinical research, and transparency topics.

• Castleberry v. Branscum: A Divided Texas Supreme Court Increases Shareholder Liability for Corporate Contractual Obligations, 19 St.

Mary's L.J. 245 (1987).

• The Political Funds Reporting and Disclosure Act of 1975, 17 S. Tex. L. J. 209 (1975-1976).

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