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Guidance for NPCs Regarding Cooperative Technology Administration Agreements (CTAA)

In 1999, VA greatly increased its frequency of retaining rights to intellectual property (IP) developed by VA employees, including VA without compensation (WOC) appointees. While no change in policy was required, this was a reversal of VA’s previous practice of routinely returning rights to IP back to the inventors. Executive Order 10096, the Bayh Dole Act which applies to university and nonprofit recipients of federal grants (codified at 37 CFR 401), a requirement that VA WOCs must sign statements assigning IP rights to VA, and disclosure requirements of various granting agencies resulted in a highly complex technology transfer environment. To manage this, VA established the Technology Transfer Program (TTP) office and began negotiating Cooperative Technology Administration Agreements (CTAAs) with VA-affiliated universities.

CTAAs 1) stipulate that VA has an interest in ownership of intellectual property (IP) developed by its employees; 2) establish that VA and the university will cooperate on equitable assertion of rights to IP developed by employees with VA and/or university appointments; 3) assign to universities the exclusive right to manage VA interests in IP; and 4) detail distribution of revenues resulting from IP. The model CTAA is available at http://www.research.va.gov/programs/tech_transfer/model_agreements/ctaa.doc

Impact on NPCs

CTAAs (previously called Inter-Institutional Agreements) assign to the university the right to administer all intellectual property resulting from VA research at the facility, including NPC-administered studies. This raises the possibility that a university would have the right to manage IP resulting from pharmaceutical studies in which the university plays no role. In some cases, CTAAs have created a disincentive for pharmaceutical companies to enter into research studies with NPCs and have complicated negotiation of clinical research agreements.

Solution

Recognizing that late stage clinical studies are the bulk of the research administered by the NPcs and that there is minimal expectation that new IP will result from such studies, TTP personnel agreed to modify the model CTAA to provide a new Option 1 for Clause 3.1 regarding licensing. The purpose of this option is to exclude from the CTAA those NPC-administered studies that are sponsored by pharmaceutical companies and that involve only collecting data on patients. Option 2 accomplishes a similar objective if it is accompanied by the recommended university blanket letter of exclusion.

CTAAs are negotiated between TTP and the universities. Generally, Research Office personnel are not participants. However, the TTP office has agreed that NPCs may work with their VA facilities and affiliated universities to modify existing CTAAs to reflect their preferred option, and TTP personnel will approve the necessary CTAA amendment. NPCs affiliated with VA facilities that do not yet have a completed CTAA should be proactive in informing VAMC personnel of their preferred option. 

For those VAMCs that do not yet have a CTAA, as of May 2003, the TTP will inform ACOSs R&D that the TTP is beginning CTAA negotiations with the university. Executive directors should education their ACOSs to immediately inform the executive director of the affected NPC upon receipt of such a notice.  This will allow the executive director to identify, and discuss with the university, the best option for CTAA Clause 3.1 regarding licensure well before the CTAA is signed.

For more information on CTAAs, go to:  http://www.research.va.gov/programs/tech_transfer/crada/affiliates.cfm

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