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To help streamline review, TTP and OGC have developed model technology transfer agreements and forms to accommodate various use cases at VA.
Principal Investigators for CRADAs must fill out the Conflict of Interest Form and submit to OGC Ethics Specialty Team (EST).
A basic SOW template intended for CRADAs and other cooperative work.
The licensing of government-owned inventions best serves the public interest when such inventions are developed to the point of practical application and made available to the public in the shortest possible time. Third parties wishing to license and commercialize VA-owned inventions may apply for a license application using the example license application template below. TTP evaluates license applications and negotiates terms with the applicant. A listing of VA-owned inventions available for licensing may be found in the TechLink database.
CRADAs provide VA with a flexible vehicle to facilitate the transfer of commercially useful technologies to the nonfederal sector. All CRADAs require a completed statement of work (SOW), R&D committee approval, and concurrence from OGC prior to execution. CRADAs may be signed by the Medical Center Director or ACOS/R where such authority has been delegated.
| Basic Science | This CRADA is intended for basic research and development, software, engineering, testing, or evaluation studies in which the VA’s Principal Investigator (PI) developed or substantially contributed to the research plan. Animal studies may be conducted under a Basic Science CRADA. |
| Data Collection | The Data Collection CRADA is for studies which involve a retrospective or prospective collection of data from patient medical records such as registries, data mining and outcomes analysis. The collaborator is not receiving individually identifiable information. |
| Material Transfer | The Material Transfer CRADA allows VA to receive proprietary materials from a collaborator. The collaborator does not make an intellectual contribution to the study and only receives a summary of any results. The agreement allows VA to provide the collaborator with an option to take a license to any invention that may arise from the research. Note: The Material Transfer CRADA must be used if a for-profit entity is providing materials to VA. Material transfers to for-profit entities may require a material license agreement to be negotiated by TTP. |
| Investigational Device | This CRADA is selected in investigational device clinical trials subject to FDA oversight. The Sponsor usually holds an FDA investigational device exemption (IDE) which allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. |
| Principal Investigator Initiated |
This CRADA is used when the VA PI has substantially designed the protocol for clinical studies with human subjects and/ or material derived from humans and most often involves the testing of post-market drugs and devices. |
| Clinical Trial Phase I-IV | This CRADA is used in clinical drug trials where the collaborator is the Sponsor, holds the FDA investigational new drug (IND) application, and developed the protocol. Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. |
A Material Transfer Agreement (MTA) allows VA to provide materials to or receive materials from third parties. Unmodified MTAs may be approved locally and signed by the Medical Center Director or ACOS/R, where such authority has been delegated.
The Basic MTA is for use only when VA is providing materials to or receiving materials from a non-profit entity or an academic institution. The MTA may not be used if (i) collaborative research is anticipated between the parties; (ii) the provider or recipient of the materials is a for-profit entity; (iii) the provider or recipient wishes to grant licensing options to or commercial rights in the transferred materials; or (iv) the transferred materials will be utilized by the recipient for production or sale. In these situations, contact TTP for guidance.
Confidential Disclosure Agreements (CDAs) may be used where VA and/or a third party wish to share confidential information in anticipation of a future relationship. For example, a CDA may be used to allow for the sharing of information needed to determine whether a CRADA is feasible. Unmodified CDAs may be approved locally and signed by the Medical Center Director or ACOS/R, where such authority has been delegated.
The most common type of inter-institutional agreement is the Invention Management Agreement (IMA), which governs the relationship between VA and academic affiliates with respect to jointly-owned intellectual property developed by dually appointed personnel.
Note: This is the replacement document for Cooperative Technology and Assessment Agreements (CTAAs).