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Preclinical Development of Therapeutic Agents
 Eligibility Criteria
 Assurances to Users
 Application Process
 Approval Process
 User Requirements
 Examples of Services by Category


Services for Researchers

Services for the Preclinical Development of Therapeutic Agents

Assurances to Users

NIAID is pursuing a determination of exceptional circumstances (DEC) to be incorporated into the Services for the Preclinical Development of Therapeutic Agents contract. A DEC would require the contractor and its subcontractors to assign their rights under the Bayh-Dole Act in any subject inventions that use or incorporate submitted material to NIAID or to the provider as designated by NIAID, or otherwise dispose of or transfer those rights as directed by NIAID.

In the interim, the Contract includes an intellectual property (IP) option that offers the provider the opportunity to negotiate an exclusive license to any NIAID contractor inventions that derive from the provider's material. This includes inventions either conceived or first actually reduced to practice by the contractor in the performance of work done under the contract using the provider's material.

The standard contract includes a clause that states that all data and other information provided by a third party supplier or the NIAID Project Officer marked as confidential will be treated as confidential, unless specifically identified as non-confidential in writing by the NIAID Project Officer.

Finally, NIAID would not prevent the submitter from negotiating separate terms and conditions directly with the contractors, as long as such terms do not conflict with the pre-negotiated contract that NIAID has in place with the contractors.


Contact Info

Program Officers, their areas of responsibility, and contact information may be found at the DMID Staff Lists.

Overall coordination of the program is managed by:
Beth Spinelli
Project Officer, Drug Development Section
Office of Biodefense Research Affairs
E-mail: spinellb@niaid.nih.gov



Contact Info

Program Officers, their areas of responsibility, and contact information may be found at the DMID Staff Lists.

Overall coordination of the program is managed by:
Beth Spinelli
Project Officer, Drug Development Section
Office of Biodefense Research Affairs
E-mail: spinellb@niaid.nih.gov