The firm has extensive experience structuring, drafting and negotiating a wide variety of complex agreements for biotechnology, medical device and pharmaceutical companies, hospitals and academic medical centers, with particular emphasis on technology transfer and research and development. In addition, the firm has experience counseling companies on physician and other healthcare professional interactions, anti-bribery/anti-corruption, scientific misconduct, false claims and pre-approval promotion.
HTLF provides biotechnology, medical device and pharmaceutical companies, universities, academic medical centers and hospitals with the following legal services:
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
Hospital acquisition and disposition agreements
Outsourcing hospital business operations, including information technology, supply chain, revenue cycle and payroll processing
Counseling regarding physician and other healthcare professional interactions, including fair market value issues
Counseling regarding anti-bribery/anti-corruption, scientific misconduct, false claims and pre-approval promotion
Conduct internal client training programs for healthcare provider interactions
HTLF Solves Electronic Medical Records and Other Vendor Contracting Issues
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.
HTLF Addresses Physician Employment and Healthcare Provider Interaction Issues
We draft and negotiate agreements for:
physician employment (whether in a group practice or at a hospital);
independent contractors and other non-physician assistance;
confidentiality and evaluation of opportunities; and
We counsel regarding the impact of physician employment and related agreements.
We provide guidance regarding physician and other healthcare professional interactions, including fair market value issues.
HTLF Advises on Physician Consulting and Clinical Research
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.
HTLF Advises on HIPAA, Physician Payment Sunshine Act and Other Legal and Regulatory Compliance Issues
We provide guidance on use and disclosure of protected health information.
We draft and review HIPAA privacy notices and privacy policies.
We structure and negotiate business associate agreements.
We counsel regarding the impact on physicians and other healthcare providers of the Physician Payment Sunshine Act, including how to dispute manufacturers’ disclosures.
We advise and train on anti-bribery/anti-corruption issues, anti-kickback, fraud and abuse, and scientific misconduct.
What We've Achieved
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.