Vice President, General Counsel and Compliance Officer

• Jul 2021 - Present

Principal | Legal Support & FDA Consulting | IP | Negotiating

• Jul 2017 - Jun 2021

I provided a diverse range of legal support to drive operations for clients engaged in the healthcare sector. 𝗔𝗱𝘃𝗶𝘀𝗲 𝗲𝗮𝗿𝗹𝘆-𝘀𝘁𝗮𝗴𝗲 𝗱𝗿𝘂𝗴, 𝗙𝗗𝗔 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴, 𝗮𝗻𝗱 𝗵𝗼𝗺𝗲 𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀. ► Facilitated clinical trial activities for early-stage drug companies, drafting and negotiating agreements for multiple national and international studies encompassing pilot programs / 20+ clinical trial sites. ► Positioned company to complete significant acquisition by evaluating comprehensive IP portfolio. ► Enabled client to enhance its IP holdings, filing additional IP claims and international trademark applications as well as seeking IP protection for 5 product improvements. ► Expedited home healthcare company’s approval with federal agency to enable rapid startup. ► Negotiated agreement with IRS to alleviate millions in corporate tax debt.

Chief Intellectual Property Counsel

• May 2006 - Dec 2016

While serving as the company’s first in-house counsel, I built a worldwide patent portfolio valued at up to $200M while leading 12 outside counsel with scientific & engineering expertise. I negotiated and drafted complex contracts (licensing, development, clinical trial, purchase, sales, distribution, research, consulting, real estate, and manufacturing). Additionally, I collaborated across the organization to advise on a diverse range of issues impacting business. ► Reduced time to activate clinical trial sites up to 80% and eliminated FDA warning on product labels. ► Developed patent portfolio valued at $200M+ and extended protections after comprehensive patent evaluation. ► Secured patent exclusivity for basic ideas by applying new scientific advancements & customer feedback. ► Completed $1.5B M&A transactions, surging growth as lead counsel handling due diligence, verifying IP, guiding outside counsel, and negotiating for $50M-$350M deals. ► Verified SEC filings and exploded corporate value 400% via stock redomiciling.

Co-Founder & General Counsel | Startup Operations | Growth Strategies

• Apr 2006 - Jun 2007

As co-founder, I led comprehensive startup of this organization, creating corporate structure, arranging funding, and drafting agreements. 𝗗𝗿𝗼𝘃𝗲 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗱𝗶𝗿𝗲𝗰𝘁𝗶𝗼𝗻 & 𝗮𝗱𝘃𝗶𝘀𝗲𝗱 𝗼𝗻 𝗹𝗲𝗴𝗮𝗹 𝗺𝗮𝘁𝘁𝗲𝗿𝘀. ► Identified growth opportunities to support production of generic drug equivalents, recognizing first-to-file opportunities under Hatch-Waxman Act, running international pilot studies, and developing litigation strategies. As co-founder, I led comprehensive startup of this organization, creating corporate structure, arranging funding, and drafting agreements. 𝗗𝗿𝗼𝘃𝗲 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗱𝗶𝗿𝗲𝗰𝘁𝗶𝗼𝗻 & 𝗮𝗱𝘃𝗶𝘀𝗲𝗱 𝗼𝗻 𝗹𝗲𝗴𝗮𝗹 𝗺𝗮𝘁𝘁𝗲𝗿𝘀. ► Identified growth opportunities to support production of generic drug equivalents, recognizing first-to-file opportunities under Hatch-Waxman Act, running international pilot studies, and developing litigation strategies.

Senior Patent Counsel | IP | Litigation | Medical Affairs

• May 2004 - Apr 2006

I led a global team of in-house IP professionals, and advised the C-suite of this life sciences company on IP, litigation, medical affairs, and due diligence. 𝗢𝗽𝘁𝗶𝗺𝗶𝘇𝗲𝗱 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀 𝘁𝗼 𝗯𝗼𝗼𝘀𝘁 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆. ► Enabled company to rapidly initiate clinical trials by surging documentation efficiency 85%. ► Revived 13 unintentionally abandoned U.S. applications identified after assuming role; restructured patent administration to mitigate future concerns. ► Managed international patent docket of 2.5K matters / 10K active trademarks to grow IP portfolio spanning large & small molecule pharmaceuticals, biotechnology methods, medical device, and diagnostic equipment. ► Invalidated third party IP claims to protect largest product from veterinary medicine subsidiary, coordinating with outside counsel to defend against third-party infringement. Earlier work included Associate roles at Arent Fox LLP as well as Potter Anderson & Corroon, LLP (The DuPont Company), where I drafted & prosecuted patent applications in in biotechnology, polymer chemistry, chemical manufacture, and new drug compositions and spurred new product development.