Request for Proposals 0001 Request for Proposals File 2 of 3

•
•
•
•
•

Notify BARDA prior to any disposal of material acquired in current and prior contracts, records, documentation, and/or reports for consultation and disposition. Dispose of material following all federal and state regulations for the appropriate waste category: hazardous waste (e.g., thimerosal-containing product), regulated medical waste (e.g. LAIV), solid waste (e.g., non thimerosal-containing product, non LAIV), etc. Provide documentation (e.g. Certificate of Destruction, COD) and reports on the performed and completed disposal activity, which must include lot/batch identifying details with total quantity disposed (total lots, volume/mass, final containers). Deliver a final report including, at minimum, the information identified in the ‘Deliverables Table’ and specified in the RTOR.
Due to the highly speculative nature of product disposal for this requirement, it is not possible to estimate, with any degree of certainty, the scope and amount required over the life of the IDIQ. As such, this Activity will not be priced at the IDIQ level, but instead at the task order (TO) or Blanket Purchase Agreement (BPA) level. TO/BPA Contracting Officers must determine price reasonableness prior to TO or BPA award.

ACTIVITY 1015: Emerging Pathogen(s)
• The Contractor must perform activities as required by BARDA and as specified in an RTOR.
• Develop, update, and submit the regulatory documentation supporting the use of the material during interpandemic periods, pandemic periods, pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed or authorized doses.
• Due to the highly uncertain and speculative nature of this Activity, it is not possible to estimate, with any degree of certainty, the scope and amount required over the life of the IDIQ. As such, this Activity will not be priced at the IDIQ level, but instead at the task order (TO) or Blanket Purchase Agreement (BPA) level. TO/BPA Contracting Officers must ensure enforcement of applicable FAR cost principles and determine cost reasonableness prior to TO or BPA award.

ACTIVITY 1016: Validation Activities or Technology Transfer Activities For situations in which a manufacturing activity would require validation activities, a technology transfer, or other activities related to a new product (e.g., new presentation or formulation of antigen and/or adjuvant at an existing location, or an existing product at a new location, etc.), the Contractor must:
•