Leah Ann Akin Email & Phone Number

Mountain View, California, United States

United States

Mountain View, California, United States

Portland, Oregon Metropolitan Area

Continuing my focus on the medical device industry, I have joined BIOTRONIK U.S., a global manufacturer of cardiac rhythm management and vascular intervention products with headquarters in Berlin, Germany. Reporting to the General Counsel of BIOTRONIK U.S., I am one of two members of the U.S. legal team, counseling all business sectors of our U.S. operations, including sales, human resources, compliance, manufacturing, research and development, clinical, regulatory, marketing and training, materials management and finance. Major focus areas include advising and supporting the business contracting unit, compliance department, sales force, marketing department and new product development teams. My role leans heavily on my specialized skills in HIPAA, GDPR, CCPA, data privacy and protection and IT security. Integral to my role is frequent alignment and collaboration with other members of the BIOTRONIK global legal team, especially on data protection and security topics as well as False Claims Act, Sunshine Act and AKS issues unique to U.S. law.

Richland/Kennewick/Pasco, Washington Area

Reporting to the CEO, I counsel Cadwell, a neurodiagnostic medical device manufacturer and software developer, on identifying and mitigating liabilities while engaging in strategic growth opportunities. I have had the unique opportunity at Cadwell of being the first in-house counsel, allowing me to work with stakeholders to identify legal needs and champion legal solutions, systems, policies and procedures across the company. In my role, I structure, draft and negotiate complex commercial agreements, including sales contracts with hospitals, GPOs, IDNs and the U.S. government, and joint venture, research collaboration, licensing and distribution agreements. I also advise the national sales team on all legal issues surrounding structured sales transactions, reviewing all BAAs and IT and data security assessments, cloud and software EULAs, remote access agreements, and Stark and Anti-Kickback certifications. Collaborating with QARA and IT, I draft policies and procedures supporting HIPAA, EU MDR, GDPR and data privacy and security requirements, keeping abreast of industry trends, requirements and certifications, including HIPAA SOCII, HITRUST and ISO27001 as they apply to medical device manufacturers. I also advise R&D constituents on confidentiality issues, draft NDAs and promote IP protection prospectively.In supporting accounting and auxiliary business units, I counsel on and draft large-scale financing and rental agreements and implement strategies for asset protection and recovery efforts through new contracting procedures and protocols. I further advise marketing efforts, reviewing and revising customer-facing literature to ensure regulatory compliance and ensure company-wide compliance with the Sunshine Act reporting requirements.

I advised Reactual, Inc., a software services start-up on structuring seed funding and later funding rounds. I drafted privacy policies, ensuring GDPR compliance and ensuring legal compliance of website interfaces. Additionally, I advised the company on corporate taxation issues and resolve intellectual property issues involving designation and protection.

Boulder, Colorado

I supported all legal aspects of the University of Colorado's $500 million research enterprise, representing the University in contract negotiations for national and international collaborative research agreements, licensing agreements, service agreements, confidentiality agreements, data usage and sharing agreements and master agreements with governmental, public and private entities. I focus on mitigating risks created by export control issues, broad warranties, indemnification, conflicts of interest, limitation of publication rights or limitations of CU’s legal remedies. I actively engage in intellectual property, licensing and background intellectual property issues, working with outside counsel to resolve licensing and ownership issues. Because many of the contracts originate with federal agencies, I must review applicability of the Federal Acquisition Regulations (FARs) and apply other complex legal frameworks guiding export control of federally sensitive research and proprietary data. I actively serve on multiple work groups aimed at systematic improvement of electronic contract and documentation management processes and procedures.

Boulder, Colorado

I researched, negotiated and drafted a broad range of contracts, research briefs, and pleadings predominantly in the context of civil litigation. My case load involved complex financial, business, tax and real estate issues. I represented clients in settlement conferences and hearings to the court. I drafted appellate briefs to the Colorado Court of Appeals and Colorado Supreme Court. In July 2013, I argued a case before the Colorado Court of Appeals.

Boulder, Colorado

I researched statutes, pleadings, legal briefs, and related legal authorities to assist my judge in adjudicating trials, hearings, appeals, and other litigated matters. I drafted proposed opinions, briefs, legal memoranda, and statements of issues involved in a case, including appropriate suggestions or recommendations to the judge. I also researched and prepared draft opinions for complex civil litigation as well as domestic matters.

I performed contract legal work, including drafting motions, briefs and discovery documents for various civil litigation matters.

I represented clients in high asset dissolutions, related domestic matters, long-term disability issues and employment law cases. Our practice involved complex trust, business and property valuation issues. I researched statutes and case law, drafting legal briefs, pleadings, motions and appellate briefs. I also participated in extensive trial preparation, depositions and hearings and represented clients before the court and in the context of mediations. One of my appellate briefs to the Colorado Court of Appeals resulted in a published opinion in my clients favor. (See In re the Marriage of Cyr, 06CA1444 (Colo. App. 2008)).

I researched FDA and OSHA regulations, audited training programs and prepared and presented compliance and process training programs. I worked on Quality System Management teams for the facility as well as the development of computer-based compliance training curriculums for facility job descriptions. My work on regulatory issues in our active pharmaceutical ingredient (API) facility prompted my decision to attend law school.

I performed validation studies on quality operations testing protocols and interfaced with the Regulatory and Analytical Services department. I regularly investigated quality control and testing issues and drafted related study reports.

J.D., Cum Laude, Law

Activities and Societies: I worked as a summer law clerk at the firm of Cook, Noell, Tolley and Bates in Athens, Georgia. There I wrote.

M.S., Magna Cum Laude, Chemistry

Activities and Societies: Teaching Assistant; National Science Foundation FellowIn graduate school as a National Science Foundation.

B.S., Summa Cum Laude, Chemistry And French

Activities and Societies: Campus Television Station News Producer; Public Relations Office Writer; Study Abroad Program.