Statement_of_Work_VRDD.docx

Statement of Work:

I. Introduction/Background:

NMRC has been developing vaccine candidates to prevent dengue virus infections. A variety of platforms have been developed which are at various stages of testing. This proposal will test the live attenuated dengue viruses developed by Codagenix Inc. using proprietary synthetic biology technology (SAVE, Synthetic Attenuated Virus Engineering) as vaccine candidates in a non-human primate (NHP) model. Under this proposal, Codagenix Inc. will provide to the Naval Medical Research Center (NMRC), sufficient quantities of vaccine material for all four dengue virus serotypes, as required for the NHP study to be executed by NMRC either in-house or under a separate contract with a CRO.

II. Technical Requirements:

The proposed NHP study (not part of this contract) requires 4 NHP to be vaccinated with 1E5 plaque forming units (PFU) of each of the 4 dengue serotype vaccines, and a second set of 4 NHP to be vaccinated similarly with 1E6 PFU of each dengue serotype vaccine. Approximately 9E6 PFU of each serotype vaccine will be required for vaccinations. For successful execution and to account for wastage and other unforeseen events, it is recommended that twice the stipulated amount be available.

III. Deliverables:

· Contractor shall provide approximately 2E7, but no less than 1.15E7 plaque forming units (PFU) of SAVE dengue-1 vaccine.

· Contractor shall provide approximately 2E7, but no less than 1.15E7 plaque forming units (PFU) of SAVE dengue-2 vaccine.

· Contractor shall provide approximately 2E7, but no less than 1.15E7 plaque forming units (PFU) of SAVE dengue-3 vaccine.

· Contractor shall provide approximately 2E7, but no less than 1.15E7 plaque forming units (PFU) of SAVE dengue-4 vaccine.

· Contractor shall provide details of characterization of each of the above as a CoA document.

· Contractor shall participate in periodic telephone conferences with NMRC Principal Investigator during the preparation and characterization of vaccine stocks and during the NHP study (not part of this contract) as needed.

IV. Applicable Documents: n/a

V. Place of Performance: At the Contractor’s site.

VI. Period of Performance: Three months from the date of award.

VII. Progress Monitoring: Monthly telephone conferences.

VIII. Acceptance Criteria: Validated CoA signed by the Contractor.

IX. Other Requirements: n/a