Cooperative Research and Development agreements

D. R. James, Technical Note No. 1, Cooperative Research and Development Agreement (CRADA), Investigation of S2p Q Production and Mitigation in... 

Cooperative Research and Development Agreement. A CRADA is designed to involve industrial and government labs in cooperative research programs. A CRADA typically has provisions for sharing technical resources, protecting confidentiality, and treatment of intellectual property. The subject CRADA was sponsored by the US Department of Energy (DOE). 

Recent advances in biotechnology have resulted in improved fermentation processes for the production of useful chemical intermediates. One such process was developed a few years ago during the U.S. DOE sponsored CRADA (Cooperative Research and Development Agreement) with Applied Carbochemicals (ACC). Under this CRADA a consortium of four national labs including Argonne National Laboratory (ANL), Oak Ridge National Laboratory (ORNL), National Renewable Energy Laboratory (NREL), and Pacific... 

Since the bottleneck on the clinical trial for taxol was in the supply, the NCI turned in 1989 to industrial partners, and issued a request for a Cooperative Research and Development Agreement, and selected Bristol-Myers Squibb (BMS) in 1991 as the partner in taxol development. BMS would take responsibility for the short-term supply of taxol, and NCI would sponsor research to deal with long-term supply. BMS collected 750,000 lbs of dried T. brevifolia bark from 38,000 trees during the 1991 growing season, sufficient to yield 25 kg of pure taxol to treat about 12,000 cancer patients. Hauser Chemical Research of Boulder, Colorado, was overseeing collection of yew bark and processing of the bark to extract taxol. BMS prepared the final dosage formulation and delivered it to the NCI for use in clinical studies. 

In 1992, LANL and the Electric Power Research Institute (EPRI) entered into a cooperative research and development agreement (CRADA) to transfer SDP to industry. Through a competitive call for proposals. High Mesa Technologies, L.L.C. (HMT) of Santa Fe, New Mexico, subsequently was selected as the third partner to commercialize and develop SDP equipment. HMT has also licensed the rights to use SDP technology for process off-gas control. In February 1997, it was reported that HMT was seeking opportunities to demonstrate a commercial SDP system for industrial off-gas treatment and anticipated that commercial units would be available in 12 to 18 months. 

More importantly, the FDA has been instrumental in the release of data and information from regulatory submissions. Matthews and Contrera (1998) report the development of MultiCASE for the prediction of carcinogenicity using data released from the FDA under a Cooperative Research and Development Agreement (CRADA). The model developed with the FDA data had greatly... 

The U.S. Food and Drug Administration (FDA) has adapted the MultiCASE technology and developed a new system known as MultiCASE QSAR-ES (quantitative structure-activity relationships expert system). This system uses the MultiCASE program and new database modules that were developed under a Cooperative Research and Development Agreement... 

The computational toxicology software programs and models were obtained by FDA/CDER/ICSAS through cooperative research and development agreements with MDL Information Systems and Lhasa Ltd (Benz, 2007)... 

So the issue is not that you are selling your research too cheaply. The issue is whether a company will pay whatever you charge compared with what, for example, Imperial College, Taiwan, or what a cooperative research and development agreement involving Los Alamos will charge. This is a common disconnect between the academic and the industrial communities on this issue, and we need to be aware of it. 

Intellectual property issues need to be addressed more effectively. In the past, collaborations typically involved a company and a federal laboratory. Simple assignments of the patents or provisions for the company to license the technology were adequate. The DOE cooperative research and development agreement (CRADA) Subject Invention definition can confuse intellectual property ownership. Today, the collaborations may involve several partners, the results may be used by joint ventures, or even more-creative business structures may need access to the intellectual property developed by the collaboration. Increased flexibility on how this property is managed is a key issue for the future. 

Should a compound show promising anticancer activity in the routine screening operations, the NCI may propose the establishment of a more formal collaboration, such as a Cooperative Research and Development Agreement (CRADA) or a Clinical Trial Agreement (CTA) (see NCI Technology Development and Commercialization Branch Website http //tdcb.nci.nih.gov). 

Under a Cooperative Research and Development Agreement (CRADA) between FDA and MultiCASE, new database modules have been developed for MCASE that contain an expanded training-set of compounds representing proprietary compounds from chemicals submitted to the agency for review and some mutagenic compounds that failed during development at pharmaceutical companies [27,28]. 

CRADA Cooperative Research and Development Agreement (with NIH)... 

Most importantly, the legislation permits the establishment of formal cooperative research and development agreements (CRADAs) in which a Federal laboratory provides personnel, services, facilities, equipment or resources (but not funds), and a non-Federal party (e.g., a private company) provides finds, personnel, services, facilities, equipment or other resources for R D. 

KEY ADAM HA- Alcohol Drug Abuse and Mental Health Administration CRADAs - cooperative research and development agreements NIH - National Institutes of Health. 

KEY AIDS - acquired immunodeficiency syndrome. CRADAs. cooperative research and development agreements HIV - human immunodeficiency virus. NCI - National Cancer Institute. PHS-Public Health Service. PMA - Pharmaceutical Manufacturer... 

Cooperative Research and Development Agreements (CRADA) A formal agreement between a Federal laboratory and anon-Federal party (individual, university, or private firm) in which the non-Federal party provides resources in exchange for exclusive rights to license patents that result from the collaboration. Congress gave Federal laboratories the authority to enter into CRADAs as part of the Federal Technology Transfer Act of 1986 (Public Law 99-502). 

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