Health & Technology Law Firm

Technology transfer agreements, including with government agencies

Commercial and university sponsored research agreements, including related patent option and license agreements

Cooperative research and development agreements (CRADAs) with NCI, NIH and other government agencies

Material transfer and evaluation agreements, including M-CRADAs with government agencies

Contract research organization agreements

Product development agreements

Joint research and development agreements

Distribution and reseller agreements

Physician and scientific expert consulting agreements

Electronic medical records and health information database design, development, licensing and operation agreements

Outsourcing hospital business operations, including information technology, supply chain, revenue cycle and payroll processing

We draft and negotiate agreements for:

• electronic medical records and health information database licensing, operation and maintenance;

• information systems and technology (hardware, software and services) acquisition, licensing, operation and maintenance;

• telecommunications acquisition, licensing, operation and maintenance;

• payroll processing software and systems; and

• outsourcing a variety of business process services. 

We counsel regarding the development of internal policies for the management of contracts and vendor relationships.

We structure Requests for Proposals, and assist in the evaluation of responses to RFPs.

We draft and negotiate physician/expert consulting agreements and research agreements with pharmaceutical, biotechnology and medical device companies, academia and the NIH and other government agencies.

We counsel regarding acting as a clinical trial study site, including drafting and negotiating clinical study site agreements with study sponsors and contract research organizations. 

We provide guidance and training regarding recruiting patients (and non-patients) as study subjects.

We advise on human subject protection and informed consent issues.

Represented a major academic medical center in the acquisition of a hospital, including sole responsibility for structuring and negotiating of over $200 million of services agreements with multiple vendors for the outsourcing of group purchasing of pharmaceuticals and other medical supplies, information technology, supply chain, revenue cycle, and payroll processing services.

Served as de facto in-house counsel for a biotech joint venture for seven years.  Responsible for intellectual property and biotechnology law aspects, from early stage research and development through product launch for the company’s first major commercial product.  Worked directly with the scientific and business personnel at the company to help them achieve a successful product launch while simultaneously securing and protecting the intellectual property rights for the novel, proprietary technology embedded in the product.  Drafted and negotiated a suite of agreements for the company that followed the product life cycle.  This included agreements for sponsored research services, CRADAs, feasibility studies, purchase and supply of key components, material transfer, patent licensing (and related patent litigation settlements), beta product leasing and commercial product sales. 

Multi-year representation as de facto general counsel for a research foundation focusing on an “orphan indication” disease, including providing advice and counsel on all legal aspects of research and consulting arrangements, intellectual property protection, and drafting and negotiating agreements for same.

Multi-year representation of a major medical device manufacturer including drafting numerous complex sponsored research agreements, patent and technology licenses and option agreements.  Successfully negotiated these agreements with UCLA, UCSF, University of Colorado, Colorado School of Mines, Duke University, SUNY Albany, Cleveland Clinic, Northwestern, University of Louisville Research Foundation, University of Maine, Dartmouth University, University of Michigan, University of Texas, the National Institutes of Health and the Department of Veterans Affairs.  Worked directly with the Principal Investigators to develop and analyze the related research budgets and review the research protocols in order to ensure compliance with fair market value, patient consent and data privacy requirements.  Analyzed for certain transactions the impact of spinning out patented technology developed by faculty into new university-sponsored companies and joint ventures.

Drafted and negotiated a comprehensive product development and commercialization agreement governing pre-clinical research through post-FDA approval manufacturing and sales activities by two pharmaceutical companies.

Drafted and negotiated multiple value-added reseller and strategic alliance agreements for a major national health IT company.  Assisted in-house General Counsel in developing templates for a variety of transactions.

Drafted and negotiated a complex database design, development and operation agreement for a national health information database focusing on perinatal and neonatal outcomes and guidance for a major obstetrics and neonatal nursing association.  Drafted and negotiated numerous pilot, beta and commercial customer license agreements for the database with multiple hospitals and medical centers.  Provided advice and counseling regarding e-commerce, data security, health information technology and patient privacy issues related to the management, acquisition and dissemination of patient outcomes and related health care information and data.

Analyzed intellectual property and technology protection, transfer and commercialization issues, business risk and other strategic considerations for a major national medical device manufacturer’s early stage/proof of concept research and development program.  Developed a checklist of key issues and guidelines for the program.