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GUIDANCE FOR NPCS REGARDING
COOPERATIVE TECNNOLOGY
ADMINISTRATION AGREEMENTS (CTAA)
- Background
- Option 1
- Option 2
- Sample University Letter
1
- Sample University Letter
2
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.
For comprehensive information about VA’s
technology transfer program, VA guidance on intellectual property and
other relevant information, please go to
http://www.vard.org/tts/entry/entry.htm
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.vard.org/tts/iia/iia.htm
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.
CTTAs are negotiated between OTT and 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.
A list of universities with approved CTAAs is
available at http://www.vard.org/tts/iia/partners.htm. An NPC may ask
the facility Research Offices to provide a copy of their CTAA.
The consequence of Option 1, or Option 2 when
accompanied by the recommended blanket letter of exclusion, is that in
the rare instance that new IP results from the vast majority of NPC-administered
pharmaceutical studies, it would be managed by VA, the NPC and the
pharmaceutical company, not the university. This should simplify one
aspect of negotiating clinical research agreements with pharmaceutical
companies.
VA grants UNIVERSITY the right to diligently seek a Licensee and to
negotiate, execute, and administer any License Agreement for the
commercial development of any Subject Invention and to administer all
such License Agreements for the mutual benefit of the parties and in the
public interest. This agreement does not apply to sponsored
pharmaceutical research studies involving only data collection regarding
the efficacy and/or safety of a drug or medical device. VA shall provide
written notification to the UNIVERSITY of any study meeting
aforementioned criteria. Where VA and/or its non-profit research
corporations receive clinical study proposals that are not data
collection only VA and UNIVERSITY agree to cooperate on a case-by-case
basis to facilitate the successful negotiation of clinical study
agreements with manufacturers or other parties consistent with the
provisions of this agreement.
VA grants UNIVERSITY the right to diligently seek a Licensee and to
negotiate, execute, and administer any License Agreement for the
commercial development of any Subject Invention and to administer all
such License Agreements for the mutual benefit of the parties and in the
public interest. The VA agrees not to license to any third
parties any Subject Invention or Property Rights unless this Agreement
is terminated in accordance with Article 7 (Termination) or Section 2.2
applies, and there are no License Agreements in effect or under
negotiation. VA agrees not to assign or commit rights in or to
any Subject Inventions or future inventions or any related Property
Rights affected by this Agreement, to a commercial research
sponsor or other entity through agreements made by VA, VA corporations
or others without prior written approval from UNIVERSITY, such approval
not to be unreasonably withheld.
An NPC should pursue Option 2 only if the university agrees to sign a
letter similar to one of the following samples. The purpose of the
letter is to provide blanket “prior written approval.”
Sample University “Blanket Prior Written Approval”
Required for Option 2
On University Letterhead
Date
Name
NPC Executive Director
NPC Name
NPC Address
NPC City, State ZIP
Subject: Clinical Research Agreements
Dear Mr./Ms. Executive Director:
Pursuant to Paragraph 3.1 of the Cooperative
Technology Administration Agreement (CTAA) between the Department of
Veterans Affairs and the Board of Trustees of the University, “VA
agrees not to assign or commit rights in or to any Subject
Inventions or future inventions or any related Property Rights
affected by this Agreement, to a commercial research sponsor or other
entity through agreements made by VA, VA corporations or others without
prior written approval from UNIVERSITY, such approval not to be
unreasonably withheld.”
By this letter, University provides prior
written approval for NPC to enter into research studies sponsored by pharmaceutical
companies without the need for
individual review by University. Further, University
agrees to honor clauses pertaining to licensure contained in study
agreements between NPC and pharmaceutical companies. That is, the study
sponsor shall be granted the first opportunity to obtain a license for
use of any invention resulting from the study.
NPC agrees to abide
by the terms of Clause 3.1 Licensure in regard to any clinical study
agreements other than those sponsored by pharmaceutical companies.
In general, VA, NPC and University
agree to cooperate as needed to facilitate the successful negotiation of
clinical study agreements with manufacturers or other parties consistent
with the provisions of the CTAA.
If you have questions, please contact
University contact. We look forward to working with you.
Sincerely,
University Official
Cc: Appropriate VA, NPC and University officials
On University Letterhead
Date
Name
NPC Executive Director
NPC Name
NPC Address
NPC City, State ZIP
Subject: Clinical Research Agreements
Dear Mr./Ms. Executive Director:
Pursuant to Paragraph 3.1 of the Cooperative
Technology Administration Agreement [CTTA] between the Department of
Veterans Affairs and University, University hereby gives
written approval to the NPC to enter into standard sponsored
medical research study agreements with commercial or non-profit research
sponsors which may commit inventions under the CTTA. NPC agrees
to discuss with University Technology Transfer Office licensing
on study agreements that have non-standard intellectual property clauses
prior to entering such non-standard agreements. In general, consistent
with this letter and as necessary, VA, NPC, and University
agree to cooperate on a case-by-case basis, to facilitate the successful
negotiation of study agreements with manufacturers or other parties
consistent with the provisions of the Agreement.
If you have questions, please contact
University contact. We look forward to working with you.
Sincerely,
University Official
Cc: Appropriate VA, NPC and University officials |
