The following template documents are intended to facilitate research partnerships between academic institutions and commercial device manufacturers. Drafts of these documents were the focus of specific discussions at a June 2015 BRAIN Initiative workshop titled Industry Partnerships to Facilitate Early Access Neuromodulation and Recording Devices for Human Clinical Studies. Information on the workshop and links to videocast proceedings are available at https://braininitiative.nih.gov/meetings/June-2015-PPP.htm.
Memorandum of Understanding (PDF - 55 KB)
The purpose of this document is to describe the nature of the Public-Private Partnership program and the signatory company's agreement to participate in the program. The document goes over the process under which Collaborative Research Agreements will be reached with academic researchers wishing to use the company's device(s) prior to their submission of NIH grant applications. Each signatory company has provided a description of the materials and support it is willing to make available for this purpose (see Devices and Support from Specific Manufacturers), and has agreed to use the template Collaborative Research Agreement for partnering with research institutions for this program.
Collaborative Research Agreement Template (PDF - 127 KB)
This is a template document to be used for agreements between device manufacturers and academic research institutions to form partnerships for submission of grant applications to the NIH for clinical research. The goal of this document is to provide standardized terms covering essential components of such agreements (e.g., intellectual property, data and publications, reporting requirements, etc.). In some cases the template language may be used as is whereas in other cases it may be a starting point for discussions.
Confidential Disclosure Agreement Template (PDF - 76 KB)
This template document can be signed by academic researchers to allow confidential discussions of proprietary details with a given company regarding the capabilities of a device for the conduct of clinical research.
For Word documents versions of the template agreements please contact Dr. Nick Langhals (email@example.com