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Glossary of Terms

CDA-Confidential Disclosure Agreement
a document used between the NIH and an outside party that defines the terms and basic criteria used to assure that the party (or parties) receiving confidential information (i.e. data, methods, procedures) will maintain the information in confidentiality and will not use the confidential information for any purpose other than that described in the CDA.
Clinical Trial CRADA
A CRADA that includes studies on humans as part of the research plan. The intramural and extramural clinical trial CRADA models address specific legal and policy issues involved in human subject research.
The non-NIH party working with the NIH scientist(s) to develop and commercialize technology.
COIFAS-Conflict of Interest and Fair Access Survey
a document filled out by the NIH PI that is reviewed and approved by the IC Ethics Office. It aids the Ethics Office in determining if Fair Access requirements have been met and if there are any conflict of interest or appearance of conflict of interest issues.
CRADA-Cooperative Research and Development Agreement
a Public Health Service (PHS) model form with additional Appendices depending on the terms of the agreement. A CRADA is a formal research and development agreement of limited duration and scope between PHS Agencies and one or more non-Federal collaborator(s) such as a pharmaceutical or biotechnology company. Research can cover basic, preclinical, or clinical areas, a combination of any, or even a nontraditional project such as developing software. The standard PHS CRADA consists of three appendices. Appendix A is the research plan which follows a standard format and details the scientific contributions of each party. Appendix B is the financial and staffing contributions of the parties which also follows a standard format. Appendix C lists the modifications to the boilerplate.
Cre/Lox MOU
a Memorandum of Understanding between DuPont Pharmaceuticals Company and Public Health Service (PHS) that describes the terms and conditions of PHS's use and distribution of DuPont's patented technology using site specific recombination of DNA involving cre recombinase and lox sites in eukaryotic cells.
CSC - Competitive Service Center
a program developed by the National Institutes of Health whereby Institute Branches and Programs can submit proposals to an NIH committee to become a service center for other Institutes in a specific area of expertise. The TTC is an approved Competitive Service Center for technology transfer services.
CTA - Clinical Trial Agreement
a document used between an Institute and an outside party to define the terms and conditions associated with the conduct of a clinical trial. A protocol describing how patients will be treated is normally appended.
EIR-Employee Invention Report
a PHS form used by PHS scientists to report inventions.
Research conducted on behalf of NIH by non-NIH scientists at non-NIH sites. NIH grantees and contractors are considered extramural.
Extramural Invention Waivers
A request made by an NIH funded institution to transfer (waive) rights in an invention to the inventor. These requests are reviewed by several NIH offices and by the Institute that funded the research from which the invention arose.
FDA-Food and Drug Administration
responsible for approval of new drugs.
Federal Technology Transfer Act (FTTA) of 1986 (PL 99-502)
Authorizes federal laboratories to enter into Cooperative Research and Development Agreements (CRADAs). The FTTA and its subsequent amendments are codified at 15 USC ยง 3710a.
IC - Institute or Center
One of the Institutes or Centers that are part of the National Institutes of Health
Research conducted by NIH scientists at NIH.
LOC-Letter of Collection
an agreement used to allow the collecting of materials from a foreign country for screening, evaluation and testing.
a form of CRADA involving the receipt of a proprietary material for a project conducted at NIH
MTA-Material Transfer Agreement
an agreement under which materials are sent out of an IC or received into an IC by NIH scientists.
OGC - Office of General Counsel
advises management and program officials of the NIH on legal issues that arise in NIH's biomedical and behavioral research, training, and disease prevention programs, including issues relating to technology transfer. OGC is also known as the Office of the NIH Legal Advisor, a component of the Public Health Division of the Office of the General Counsel, Department of Health and Human Services.
OncoMouse MOU
a Memorandum of Understanding between E.I. DuPont de Nemours and Company and Public Health Service (PHS) that describes the terms and conditions of PHS's use and distribution of DuPont's patented technology concerning transgenic non human mammals and cells derived therefrom that contain a recombinant activated oncogene sequence.
One-way CDA
a CDA that protects information flowing from the provider to the recipient only and not vice versa.
OTT-Office of Technology Transfer
an office within the NIH Office of the Director responsible for overseeing patent prosecution and negotiating and monitoring patent licensing for the NIH Institutes and the Food and Drug Administration (FDA). OTT is also responsible for the central development and implementation of technology transfer policies for four research components of the PHS: the NIH, FDA, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality.
Outside Party
the non-NIH party with whom TTC is negotiating an agreement.
SLA - Simple Letter Agreement
Streamlined form of material transfer agreement (MTA) approved for use at NIH. NIH encourages the use of the SLA to facilitate exchanges between academic institutions.
TDC - Technology Development Coordinator
Person within each Institute who is responsible for the technology transfer activities of the Institute.
Two-way CDA
a CDA that protects information flowing both to and from all parties involved in the discussion.
is a Master Agreement among the NIH, universities, and other non-profit research facilities used to expedite transfer of research materials among non-commercial entities. Signatories to the Master Agreement are found at http://www.autm.net/aboutTT/aboutTT_umbtaSigs.cfm.
UBMTA Implementing Letter
Letter that is signed by the appropriate individuals of both non-commercial parties to transfer materials under the terms of the UBMTA.
Page Last Updated: 12-02-2008