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Concerning compensation issues, the NCI applies for patents on active agents isolated from 

 plants and other organisms collected from source countries. Should an agent eventually be 

 licensed to a pharmaceutical company for production and marketing, the NCI will require the 

 successful licensee to negotiate and enter into an agreement with the appropriate organization 

 or Government agency in the relevant source country. Such an agreement will address the 

 concern of the source country that appropriate organizations, agencies, and/or persons receive 

 royalties or other forms of compensation. The NCI will also require the successful licensee 

 to seek as its first source of supply the natural products available from the original source 

 country. This process is already underway for conocurvone; other compounds will follow 

 suit as they reach the appropriate point in development. 



POLICIES FOR DISTRIBUTION OF EXTRACTS TO 

 ORGANIZATIONS OUTSIDE THE NCI: 

 MATERIAL TRANSFER AGREEMENTS 



The NCI Natural Products Repository represents an invaluable national resource for the 

 discovery of potentially valuable drugs. A great deal of interest has been shown by other 

 research organizations and companies in the screening of materials from the repository, 

 utilizing different screens and approaches from those of the NCI. After consulting source 

 country representatives, either directly or through their respective collection contractors, the 

 NCI has formulated a policy for the distribution of extracts to carefully selected 

 organizations. In applying for access to NPR materials, research organizations and individual 

 investigators must submit research proposals which clearly delineate the research to be 

 performed. The importance and relevance to the NCI mission, prior work in the area, the 

 specific approach to be used, and the ability to carry out the research in a timely manner all 

 need to be clearly defined in the proposals. Screening must be for activities against diseases 

 related to the NCI mission (cancer, AIDS, opportunistic infections) or against diseases which 

 have an impact on health in developing countries. The inclusion of diseases of major concern 

 to developing countries is considered very important, since most of the countries participating 

 in the NCI collection program are developing countries. Proposals are reviewed by a 

 committee of senior NCI staff, and are judged primarily on their scientific merit and the 

 relative importance of the proposed research. A key factor determining the selection of 

 recipient organizations is the agreement by the organizations to abide by the same policies of 

 compensation and raw material supply as stated in the LOC. Approval for distribution of 

 extracts is granted only after the organization has signed a legally binding Material Transfer 

 Agreement (MTA) with the NCI. The MTA contains a clause guaranteeing the rights of 

 source countries to compensation in the event of production and marketing of a drug from an 

 organism collected within their borders, and requiring the recipient to utilize the host (source) 

 country as the first source of supply of raw material for production of the marketed agent. 



DRUG DISCOVERY AND BIOLOGICAL DIVERSITY CONSERVATION 



The NCI states in its LOC that "while investigating the potential of natural products in drug 

 discovery and development, NCI wishes to promote the conservation of biological diversity." 



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