Academic and Medical Research Collaborations
Working alongside our colleagues across Arnold & Porter, members of our Tax-Exempt Organizations team represent medical research and other tax-exempt clients and advise higher education clients on the full spectrum of legal issues involved in research and development, from the initial stages through commercialization. We have a successful track record of helping our nonprofit clients move the needle on medical research so that they can effectively provide patients with life-saving treatments.
We assist clients who make traditional academic grants as well as those involved in research collaborations between tax-exempt organizations and between tax-exempt organizations and for-profit entities. Our work includes helping medical research organization establish multi-institution consortia focused on developing solutions for various conditions. These multiparty collaborations benefit from our deep and unique understanding of university policies regarding conflicts of interest, patents, publications, licensing, and similar matters. This experience is crucial for structuring and operating the consortia and in the spin-out of commercial entities.
Our multidisciplinary team has wide ranging expertise on regulatory, transactional, operational, and litigation issues such as rules relating to tax/tax-exempt compliance; joint research and funding agreements; healthcare delivery; research misconduct/integrity; conflicts of interest; government grants and contracts (including Bayh-Dole Act compliance); data privacy; export controls; and governance. Our work with clients supports their basic and translational research —including industry collaborations); clinical trials, and human subjects research compliance. We also assist their efforts to spin-out companies that are built on nonprofit-funded intellectual property in alignment with their charitable missions to advance critical therapies.
How We Can Help
- Establishing multi-institution consortia focused on development solutions for various conditions, such as cancer immunotherapy, bipolar disorder, schizophrenia, immunology, neurometabolomics, Type 1 diabetes, neurofibromatosis, Charcot-Marie-Tooth disease, and other disease- or cause-specific areas
- Developing innovative approaches to structuring and funding basic and translational research
- Advising on tax-exempt issues, including program-related and mission-related investing and taxation of endowments
- Developing IP and commercialization policies to apply to funded research
- Establishing research affiliations with universities and other institutions
- Creating joint ventures with for-profit pharmaceutical and life science companies
- Advising on structuring and establishing technology transfer practices and procedures and preparing related documents, including invention disclosure forms; non-disclosure agreements; option agreements;, and license agreements
- Preparing conflict of interest and conflict of commitment policies to ensure outside professional activities and financial dealings of employees and board members, including in the context of research activities, do not interfere with their commitment of time and intellectual energy to the organization
- Maintaining the integrity and transparency of financial relationships among organization directors, employees, and outside entities by implementing established policies and advising on fiduciary and governance matters
- Advising philanthropic and institutional clients on their investments to bring new technologies or breakthrough treatments to market
- Developing data sharing policies and practices that protect the patentability of IP while enabling grantees to learn from and build upon each other’s work
- Structuring AI policies for scientific research
- Counseling organizations on export controls and other regulations governing the transfer of sensitive medical technologies and information
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