19_75A50126R0001_RFP Att 19 Surge Manufacturing and Supply Chain Readiness Assessment.pdf

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Attached to
Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response
Solicitation number
75A50126R00001_RFP_NPIVS_27
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This is a contract clause (Attachment 19) requiring contractors to submit a Surge Manufacturing and Supply Chain Readiness Assessment for BARDA-supported products upon written direction from the Contracting Officer's Representative (COR).

Upon COR direction, contractors must evaluate their ability to manufacture, test, release, package, store, ship, and deliver products under specified planning scenarios, which will include target quantities, product presentation, requested delivery timelines, planning assumptions, due dates, and public health emergency context. The assessment must identify production constraints (manufacturing, testing, release, packaging, storage, shipment), component and service constraints, supply chain constraints, logistics constraints, and potential Government actions to support timely performance. Required assessment components include: proposed manufacturing and delivery approach; expected production cadence, cycle time, and projected product availability; manufacturing and supply chain constraints affecting delivery timelines; limiting factor components or services with known source availability and lead time information; inventory and replenishment needs; supply chain nodes where Government action may assist; mitigation options and alternate sources; and contractor points of contact with proposed status update frequency if the scenario proceeds to active order. Contractors must promptly notify the COR of any material changes affecting the assessment, including changes in production availability, component availability, service availability, source qualification, lead time, transportation restrictions, logistics pathways, or Government support needs. The Government will provide a submission template for this assessment.

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Other files

File Type Posted
23_75A50126R00001_RFP_0002 Att. 21 BARDA Responses to Contractor Question No's 1-10.pdf PDF
24_75A50126R00001_RFP_0002 SF_30..pdf PDF
01-75A50126R00001_RFP_Final.pdf PDF
21_75A50126R00001_RFP_0001_RFP File 1 of 3.pdf PDF
20_75A50126R00001_RFP_0001.SF30.pdf PDF
21_75A50126R00001_RFP_0001_RFP File 3 of 3.pdf PDF
22_75A50126R00001_RFP_0001 Att. 20 BARDA Responses to Contractor Question No's 1-7.pdf PDF
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09-75A50126R00001_RFP Att 9 ACH Vendor Misc Payment Enrollment Form.docx DOCX document
04-75A50126R00001_RFP Att 3 Vendor Production Facilities.xlsx XLSX spreadsheet
16-75A50126R00001_RFP Att 16 Bill of Materials (BOM) Template.xlsx XLSX spreadsheet
11-75A50126R00001_RFP Att 11 SF LLL Disclosure of Lobbying Activities Form Instructions.pdf PDF
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08-75A50126R00001_ RFP Att 8 Summary of Related Activities.docx DOCX document
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15-75A50126R00001_RFP Att 15 Contractor Questions.xlsx XLSX spreadsheet
17-75A50126R00001_RFP Att 17 Manufacturing Plan.pdf PDF
06-75A50126R00001_RFP Att 5 BARDA Dose Tracker Template.xlsx XLSX spreadsheet
12-75A50126R00001_RFP Att 12 HHS Subcontracting Plan Template.docx DOCX document
05-75A50126R00001_RFP Att 4 Agent Request Form.docx DOCX document
02-75A50126R00001_RFP Att 1 Prod Handling Guidance Don Nat.pdf PDF
07-75A50126R00001_RFP Att 7 Breakdown of Proposed Costs.xlsx XLSX spreadsheet
14-75A50126R00001_RFP Att 14 Past Perfomance Questionnaire Template.docx DOCX document
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Surge Manufacturing and Supply Chain Readiness Assessment Clause | Page 1

ATTACHMENT 19

Surge Manufacturing and Supply Chain Readiness Assessment

Upon written direction from the Contracting Officer’s Representative (COR), the Contractor must submit a Surge Manufacturing and Supply Chain Readiness Assessment for the BARDA supported product. The requirement must identify, or the COR must provide, the applicable planning scenario, target quantity, product presentation, requested delivery timeline, planning assumptions, due date, and any relevant public health emergency context.

The assessment must evaluate the Contractor’s ability to manufacture, test, release, package, store, ship, and deliver the product under the specified planning scenario. The assessment must identify production constraints, component and service constraints, supply chain constraints, logistics constraints, and potential Government actions that may support timely performance.

Depending on the assessment planning scenario specified, the assessment must include, to the extent applicable and reasonably available at the time of submission:

1. Proposed manufacturing and delivery approach for the specified planning scenario.

2. Expected production cadence, batch or lot assumptions, cycle time, testing time, release time, packaging time, storage requirements, shipment timing, and projected finished product availability.

3. Manufacturing, testing, release, packaging, storage, shipment, component, service, supplier, distributor, or manufacturer constraints that may affect the requested delivery timeline.

4. Components or services expected to be limiting factors, including known source availability, lead time, shelf life, storage condition, transportation restriction, foreign source status, single source or sole source status, and alternate source status where known.

5. Inventory, replenishment needs, ordering constraints, and timing risks for components or services needed to support the specified planning scenario.

6. Supply chain nodes for which Government action may support the requested timeline.

7. Mitigation options, alternate sources, unresolved dependencies, and decision points requiring

Contractor or Government action.

8. Contractor points of contact and proposed status update cadence if the planning scenario proceeds to an active order, option, or other funded action.

The Contractor must promptly notify the COR after identifying a material change that could affect the assessment, including a change in production availability, component availability, service availability, source qualification, lead time, transportation restriction, logistics pathway, or need for Government support.

A submission template will be provided.

File details come from the government source that posted it. Updated .