2 PAM Autoinjectors   2

Background
This acquisition will allow BARDA to invest Project Bioshield funds for late-stage clinical development, regulatory approval for 2-PAM autoinjectors (as a drug/device combination product) to treat organophosphate (OP) poisoning, including nerve agents, in adult and pediatric populations, and procurement of 2-PAM autoinjectors for the SNS/CHEMPACK Program.

Work Details
The scope of the base period will include late-stage development activities necessary to support FDA approval of 2-PAM autoinjectors and the initial procurement of 2-PAM autoinjectors. Optional CLINs will include procurement of autoinjectors as well as additional late-stage development activities, fulfillment of additional USG security requirements as necessary and Post-Marketing Commitments. Procurement options represent a series of incremental purchases of 2-PAM autoinjectors until the entire requirement for the manufacturing and procurement of approximately 2,000,000 2-PAM (600mg) autoinjectors are met.

Period of Performance
The base period of performance of this contract is anticipated for thirty six (36) months from the date of award. The period of performance may be extended with the exercise of option(s), structured as CLINs, as set forth in SECTION B.

Place of Performance
Deliveries will take place at Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response, 200 C Street, S.W., Washington, D.C. 20024.