Tender Details

Country: USA
Summary: Notice of Intent to Sole Source-Freeze Dried Plasma (W81xwh-20-C-0088 Modification)
UST Ref No: 101645606
Deadline: 07 Jun 2024
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.:
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Description:
Description
Notice of Intent to Sole Source
The United States Army Medical Research Acquisition Activity (USAMRAA) on behalf of the United States Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care Project Management Office (WPAC PMO), intends to execute a modification (W81XWH-20-C-0088) on a sole source basis under the authority of FAR 6.302-1(a)(2), only one responsible source and no other supplies or services will satisfy agency requirements, to Vascular Solutions LLC, 6464 Sycamore Court N, Maple Grove, Minnesota, 55369. This requirement will continue providing necessary equipment, personnel, facilities, and supplies to conduct the objectives in accordance with the contract schedule and proposal titled, “Advanced Development Activities Necessary to Successfully Obtain Commercial Viability of an U.S. Food and Drug Administration (FDA) Licensed Freeze-Dried Plasma (FDP) Product.”
Vascular Solutions LLC is the only source able to meet the Government requirements. The purpose of this contract is to continue conducting several activities necessary to successfully obtain and sustain commercial viability of an FDA licensed FDP product. This modification will increase the level of effort and extend the contract period of performance end date from 14 September 2024 to 14 September 2025 (12 months). The short-term requirement/increase in the level of effort will add quality management and maintenance support activities, such as supplier quality management, materials management, Blood Establishment Computer Software administration/maintenance, quality management systems and change management support, quality assurance reviews of documents/data, and equipment maintenance support. These activities support manufacturing readiness and support the Biologic License Application (BLA) re-submission. Vascular Solutions LLC is the regulatory sponsor of the BLA and will manufacture, market, and distribute the FDP product. There are n...
Documents:

B01-W81XWH-20-C-0088-P00010-NOI-Sole-Source-20240523-Posted.docx

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Notice of Intent to Sole Source-Freeze Dried Plasma (W81xwh-20-C-0088 Modification) - USA Tender

The DEPT OF DEFENSE, a Government sector organization in USA, has announced a new tender for Notice of Intent to Sole Source-Freeze Dried Plasma (W81xwh-20-C-0088 Modification). This tender is published on USARFP under UST Ref No: 101645606 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2024-06-07.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.