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The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the Center for the Biomedical Advanced Research and Development Authority (BARDA) and was reauthorized under the PAHPA of 2013 and again in 2019 under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), Public Law No. 116-22, to support development and acquisition of medical countermeasure (MCMs) to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza (PI), and emerging infectious diseases (EID). These MCMs include vaccines, therapeutics, diagnostics, and medical devices. Additionally, BARDA is entrusted to foster innovation of technologies that enable better manufacturing, testing, and utilization of these medical countermeasures. The overall objective of this contract is to advance the development of FloPatch FP120 with FloPredict Alert for Burn and Blast Medical Countermeasure. The scope of work for this contract includes clinical and product development activities that fall into the following areas: clinical studies, algorithms, hardware and software development, and all associated regulatory, quality assurance, management, and administrative activities. The Government has determined a Bona Fide Need for each non-severable discrete work segment which will conclude upon the completion of a defined tasks that provide(s) independent merit and value to the Government. The Contractor's success in completing the required tasks under the work segments must be demonstrated through the Deliverables and Milestones specified under Article F of this contract. As set forth in Attachment 1, Statement of Work, the Go/No-Go, Deliverable, and/or Milestone will constitute the basis for the Government's decision, at its sole discretion, to exercise any follow-on option period(s).
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