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A--Notice of Intent to Award Sole Source

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W81XWH14R0036Federal

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The United States Army Medical Research Acquisition Activity (USAMRAA) plans to award a sole source contract to Entegrion Inc. for continued development of a rapidly acting platelet derived hemostatic agent (PDHA) aimed at treating non-compressible bleeding. This contract supports the submission of an Investigational New Drug application to the FDA for Stasix, a PDHA product made from fresh platelets stabilized and freeze-dried, for which Entegrion holds key licenses and patents. The contract will be awarded without full and open competition under statutory authority, as no other suppliers or services can meet the specialized research requirements needed by the U.S. Army Medical Materiel Development Activity’s Pharmaceutical Systems Project Management Office (PSPMO). The contract is categorized under NAICS code 541711 and will be managed through FAR Part 6.302-1, which permits sole source award when only one responsible source exists. The contract emphasizes the continuation of Entegrion’s unique proprietary technology in developing Stasix, reflecting the Government’s recognition of Entegrion’s exclusive capability to fulfill these highly specialized research services. This effort is crucial to advancing medical treatment options for battlefield injuries involving severe bleeding, reinforcing the strategic importance of this sole source award.

General Info

US Army awards sole source contract to Entegrion for developing patented hemostatic agent Stasix.

Agency

N/A

NAICS

541711 - Research and Development in Biotechnology

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Timeline

Posted

special-notice

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Organization & Contact Information

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AgencyN/A
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Full Description

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The United States Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, Maryland, 21702, intends to award a sole source contract to Entegrion Inc. for the continuation of the development of a rapidly acting, platelet derived hemostatic agent (PDHA) for the treatment of non-compressible bleeding through the submission of an Investigational New Drug application with the FDA. Specifically, the Government is seeking the enhancement of Stasix, a PDHA product made from fresh platelets stabilized with paraformaldehyde and subsequently freeze-dried in the presence of albumin which Entegrion holds two licenses and patents/pending patent applications. The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under the statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1), FAR citation is 6.302-1(a)(2)(iii) and the FAR citation title is only one responsible source and no other supplies or services will satisfy agency requirements for these highly specialized research services. This requirement is in support of the Pharmaceutical Systems Project Management Office (PSPMO) of the U.S. Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, Maryland, 21702. In accordance with FAR Part 6.302-1 (a)(2)(iii), USAMRAA intends to award a sole source contract to Entegrion, Inc., under NAICS code 541711.

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