Paulette Mara Photo

Paulette M. Mara

Partner
*Not admitted in D.C.

Overview

Paulette has more than 25 years of experience representing pharmaceutical, medical device, biotech, and healthcare companies, financial institutions and financial services companies in complex regulatory, transactional, and litigation matters.

A core theme of Paulette’s legal career has been working in highly regulated industries, and she utilizes her industry experience to address clients’ legal needs perceptively and efficiently. She is known for bringing a strategic and practical approach to her work within the life sciences, agribusiness, and financial services industries, with a focus on FDA regulatory matters, research and development, intellectual property licensing, co-development and co-promotion strategic alliances, privacy, compliance, litigation, and product protection. Drawing on her substantial industry background, Paulette is able to navigate clients’ needs from their perspective, and add substantive and insightful counsel to address issues cross-functionally.

 

Paulette assists clients in the following industries:

  • Pharmaceutical and biologics
  • Medical device and medical software
  • Healthcare
  • Food and agriculture
  • Financial services

Prior to joining the firm, Paulette worked at two AmLaw 100 law firms and in-house at major healthcare and pharmaceutical companies. Most recently, Paulette was a partner at a New York City law firm, serving the life sciences and financial services industries. 

Experience

Pharmaceutical and Biologics

Paulette counsels pharmaceutical and biotech companies on FDA, clinical trials, promotional, privacy and compliance matters. Paulette is also involved in negotiating and drafting development agreements, licensing and option agreements, and co-development and co-promotion alliances. She advises pharmaceutical brand teams with respect to FDA regulatory, promotion, competitor, compliance and counterfeiting matters, and handles litigation matters involving product liability, advertising, trade secret, ERISA, and privacy matters.

Medical Device and Medical Software

Paulette provides FDA counseling and handles clinical trial agreements and intellectual property licensing for medical device companies. This work includes representing medical device companies seeking to retain intellectual property rights, as well as to contract for manufacturing and other services following mergers and spin-offs, all of which involve FDA-related issues.  Paulette has also handled transactions involving an exclusive license to produce, commercialize, and distribute a diagnostics product; clinical trial and contract research organization agreements; licensing of development rights for medical device products; and medical device accessory software licenses.

Food and Agriculture

Paulette has drafted and negotiated development agreements involving dietary supplements and counseled on advertising issues. 

Financial Services

Paulette has served as counsel on global transactions, provided guidance on regulatory matters for major financial institutions, and drafted and negotiated a wide range of complex agreements. She has also successfully represented financial institutions in a number of different litigation matters.

Honors & Recognitions

  • International Who’s Who of Life Sciences Lawyers
  • “New York Super Lawyers” list, Civil Litigation Defense, Super Lawyers Magazine, 2014-2016

Professional Activities

  • Member, International Association of Privacy Professionals
  • Member, American Bar Association
  • Member, National Association of Women Lawyers
    • Co-Chair, Financial Services Affinity Group
    • Co-Chair, Amicus Committee
  • Member, Association of University Technology Managers

Education

Admissions

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