General Counsel, Chemical Engineering, Medical Device, Pharmaceutical

Margaret A. Kivinski, P.E., Esq.

** ******** ******, ****** ******, CA 92677

949-***-**** cell 949-***-**** home

Email: adip59@r.postjobfree.com

SUMMARY: Highly experienced general corporate counsel with intellectual property expertise. More than 20 years legal experience primarily in high growth biotechnology, pharmaceutical and medical device companies, both private and public. Strong technical background. Valued legal advisor with R&D and clinical support focus, intellectual property portfolio growth and management, licensing, litigation management, regulatory compliance, contracts and commercial transactions.

EXPERIENCE:

Ambry Genetics Corporation, a Konica Minolta company, Aliso Viejo, CA 2017-2020

Assistant General Counsel

Provide legal review for a heavy volume of contracts including laboratory services, managed care, research collaborations, licenses, data access, software, material transfer, confidentiality and consulting agreements.

Advise on legal matters including privacy, intellectual property, and legal issues applicable to specialized genetic testing business including transactions, compliance and litigation matters.

Partner with various business units for legal advice, counsel and review and participation on teams for special projects and initiatives.

RGP, Inc. 2015-2017

Consultant

Legal consultant to client companies.

Provided legal support for R&D group of pharmaceutical company including review of high volume of clinical contracts and related documents. Advised clinical and nonclinical research, clinical development, pharmaceutical development and supply, medical affairs, pharmacovigilance,regulatory, quality and audit functions.

Supported active clinical program including phase 1 through 4 clinical trials. Prepared templates and reviewed agreements and study-related documents, protocols, informed consents, HIPAA authorizations, clinical trial agreements, vendor and consultant service agreements and regulatory submissions.

Galena Biopharma, Inc., Portland, OR 2014-2015

Vice President and General Counsel

General Counsel for publicly-traded commercial biopharmaceutical company with full range of corporate legal responsibilities.

Corporate Secretary and Chief Compliance Officer.

Managed litigation and investigations to resolution, including a securities class action, derivative lawsuit, contract disputes, employment claims, and ANDA litigation.

Strategic intellectual property procurement and licensing.

Spectrum Pharmaceuticals, Inc., Irvine, CA 2013-2014

Contract Attorney

Contract attorney for public pharmaceutical company with over $250 million in sales handling commercial and clinical transactions, corporate governance, securities, and mergers and acquisitions.

Member of the compliance team.

Edwards Lifesciences Corporation, Irvine, CA 2012-2013

Intellectual Property Counsel

Intellectual property portfolio management and general legal consulting for a $9 billion publicly-traded medical device company with nearly $2 billion in sales and a patent docket of over 1200 patents and applications reducing outside counsel spend and working off backlog of unfiled patent applications.

Masimo Corporation, Irvine, CA 2010-2011

Vice President and Assistant General Counsel

Provided legal support for a publicly-traded global medical technology company with over $400 million in sales, focusing on patent and trademark management, agreement review, litigation management, export licensing, corporate governance, regulatory filings, regulatory and contractual compliance and risk management, and company investigations.

Chief Compliance Officer of comprehensive compliance and risk management program.

Formed political action committee and participated on numerous cross-functional committees.

Conducted investigations involving violations of policy, laws and regulations, and recommended and implemented corrective actions. Provided guidance on employment matters, including federal and state employment actions, class actions, and department of labor and qui tam investigations.

TherOx, Inc., Irvine, CA 2000-2010

Vice President of Intellectual Property, General Counsel and Corporate Secretary

Senior legal advisor to venture-backed medical device company and its board of directors on all aspects of medical device company operations.

Grew intellectual property portfolio from 18 to 69 US patents for company’s core technology.

Key participant in IPO preparation including registration statement filed in September 2008, associated due diligence and obtaining intellectual property and regulatory legal opinions.

Key participant in multiple financings, resulting in over $70 million raised.

Corporate Secretary and Chief Compliance Officer.

Provided regulatory support throughout a PMA process, clinical trials, manufacturing, marketing, sales and reimbursement.

Beckman Coulter, Inc., Fullerton, CA 1996-2000

Senior Patent Attorney

Responsible for large global intellectual property portfolio of over one thousand patents and trademarks world-wide, including integrating intellectual property portfolios from acquisitions including Hybritech.

Loeb & Loeb, Los Angeles, CA (previously Spensley, Horn, Jubas & Lubitz) 1994-1996

Associate

Patent prosecution, counseling, litigation and transactions practice for chemical, pharmaceutical, biotech, medical device and mechanical inventions, with a strong emphasis in optics, for various clients in those industries.

Fluor Daniel, Irvine, CA 1987-1993

Process Engineer

Petroleum refining and gas processing engineering design project experience.

EDUCATION:

Juris Doctorate, Cum Laude, Western State University, College of Law, Irvine, CA, 1994

Law Review, Technical Editor

California Court of Appeal Extern and Ninth Circuit Court of Appeals Law Clinic

Bachelor of Science, Chemical Engineering, University of California at Los Angeles (UCLA), 1987

REGISTRATIONS:

Patent Attorney, U.S. Patent & Trademark Office,Reg. No. 38,517

Professional Chemical Engineer, California, CH 4733

PROFESSIONAL ASSOCIATIONS:

Orange County Patent Law Association, past President

AdvaMed, member of Legal Committee IP Working Group

Association of Corporate Counsel

PUBLICATIONS:

“The Burroughs Decision: Conception of Invention in Pharmaceutical Applications,” Patent World,

March 1995, reprinted in Intellectual Property World, March 1995.

SPEAKING ENGAGEMENTS:

Harvard Business Growth Conference 2011, “Managing Intellectual Property” (received highest

rating at conference)

Orange County Patent Law Association Annual Seminar, “Inside Perspectives: Advice to Outside

Counsel”

Life Science Industry Council, “Intellectual Property for Start-Up Companies”

Whittier Law School Spring 2005 Intellectual Property Seminar Series, “Intellectual Property

Management: Budgeting and Managing Outside Counsel”

ADMISSIONS:

California State and Federal Courts

Ninth and Federal Circuit Courts of Appeal

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