This is the first of several emails I will be sending, each of which will have as many as three attachments. The CRADA Work Group, which remains comprised of NAVREF, TTP and OGC representatives, has completed work on three new model CRADAs as well as accompanying standard operating procedures (SOPs) and negotiating guidance.

All of these documents will be posted on the VA intranet shortly. Because slight changes may be made from time to time, after the models have been posted, please draw the latest version from the VA intranet each time a model CRADA is needed.

Attached are the model Material Transfer CRADA and relevant SOPs and annotations. The model MT CRADA is designed for situations in which a Provider is giving research material to VA, no other exchange of personnel or resources (i.e., no funding) is contemplated, and the Provider wishes to establish intellectual property ownership and licensing terms in advance of supplying the material. If there are no IP issues, then a Material Transfer Agreement (MTA) may be used. For the VA model MTA, go to http://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

Because there are no funds to administer, there is no financial role for NPCs in MT CRADAs and as a result, the model is a two-party CRADA between VA and the Provider. Regional Counsel will follow the previously published “Legal Review Procedure for CT CRADAs,” which is being expanded to cover MT CRADAs.

Although NPCs are not parties to MT CRADAs, NPC personnel are encouraged to become familiar with the attached documents to assist VA PIs in identifying the model CRADA appropriate for the research they are contemplating.

Please watch for two more emails with the new model Device and Basic Science CRADAs. Work has started on the model PI-Initiated Clinical CRADA which will be the last model developed by the CRADA Work Group. Because this will be similar to the already-published Phase I and II Clinical Trial CRADA, it should be available shortly.

The documents being published this week represent many, many hours of work by the CRADA Work Group and others who contributed language and reviewed drafts. Many thanks to TTP and OGC as we all work toward full implementation of CRADAs.

Please note: This week, Ms. Kris Burton joined the TTP staff as a tech transfer specialist. Kris has a background in technology commercialization and most recently worked in this area at Rensselaer Polytechnic Institute of Troy, New York. Kris may be reached at Kris.Burton@va.gov. NAVREF welcomes Kris!