HEALTH (LIFE SCIENCES, MEDICAL DEVICES)

Health (Life Sciences and Medical Devices)

Experience with a foreign medical devices entity, as disclosed US agent for all US legal work.

Legal support for the development of analytical equipment and technologies, biomarker technologies, diagnostic equipment and tests, investigative routines, new drug development, therapeutic equipment and testing.

Legal support as General Counsel for the creation of a start-up US subsidiary to manufacture human identification devices (HIDs).

Compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code and regulations promulgated by the Centers for Medicare and Medicaid Services (CMS) – such as the 1988 Clinical Laboratory Improvement Amendments (CLIA) – the Food and Drug Administration (FDA) – such as 21 CFR Part 11, Part 801, Part 803, Part 806 and Part 820 – the Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC), as well as applicable federal laws such as Sarbanes-Oxley (SOx).

Drafting and negotiation agreements for licensing, options, sponsored research and collaboration opportunities

Responsible for all required transactional work such as corporation formation, contracts (such as for intellectual property issues, employment, procurement, outsourcing, telecommunications, software, hardware, IT services, business associate, and all other required contracts of any type), real estate leases, real estate purchases, representation at state and local proceedings and corporate functions (General Counsel and Secretary, board meetings minutes, record keeping, corporate policies, employee handbook, records retention, corporate policies).

Legal support for biomedical research, related technologies and technology licensing.

U.S. General Counsel for a life sciences and genetic research international corporation, with the goal of offering an Initial Public Offering (IPO) after three years; responsible for authoring founder stock option plans, equity participation and compensation plans, negotiation and authoring of venture capital and financing agreements; compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code and regulations promulgated by the Centers for Medicare and Medicaid Services (CMS) - such as the 1988 Clinical Laboratory Improvement Amendments (CLIA) - the Food and Drug Administration (FDA), such as 21 CFR Part 11, Part 801, Part 803, Part 806 and Part 820, the Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC), as well as applicable federal laws such as Sarbanes-Oxley (SOx); responsible for all required transactional work such as corporation formation, contracts (such as for intellectual property issues, employment, procurement, outsourcing, telecommunications, software, hardware, IT services, business associate, and all other required contracts of any type), leases, real estate purchases, representation at state and local proceedings and corporate functions (such as Secretary, minutes of board meetings, record keeping, corporate policies, employee handbook).

In-house management of the processes for copyrights, trademarks and patents relating to authorship, inventions or research initiated by individuals, joint ventures, or institutions, in coordination with outside law firms and experts.

Consultation for medical device companies regarding device classifications and whether the premarket approval (PMA) or the 510(k) processes would be more appropriate.

Evaluation of new articles, devices, products and research for copyright, trademark and patent possibilities.

Last updated 200730_1945