SPECIAL NOTICE
99 -- Notice of Intent to Negotiate on a Sole Source Basis to Extend the Period of Performance to May 2012 for Development and Licensure of Recombinant Botulinum AB Vaccine
- Notice Date
- 6/1/2005
- Notice Type
- Special Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- USA-SNOTE-050601-003
- Archive Date
- 7/31/2005
- Description
- The U.S. Army Space and Missile Defense Command intends to modify contract DAMD17-98-C-8024 and negotiate on a sole source basis with DynPort Vaccine Company LLC (DVC) to extend the development and licensure period of performance to May 2012. The Jo int Vaccine Acquisition Program Management Office requires a recombinant botulinum vaccine that provides protection against aerosol exposure to toxin serotypes A and B. This contract modification shall be issued using other than full and open competition procedures in accordance with FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. It would take an unacceptable amount of time and require substantial duplication of costs to reach the stage of deve lopment of the DVC recombinant botulinum vaccine. The DVC recombinant botulinum toxin AB injectable vaccine candidate is sufficiently mature to enter a Phase 2 clinical trial by January 2006, has an existing good manufacturing practices (GMP) production f acility and a demonstrated manufacturing process scaled to meet production requirements of 1.2 million troop equivalent doses (1 troop equivalent dose = number of doses in primary vaccination series). No other contractors have a recombinant botulinum toxi n AB candidate at this stage of development. This is not a request for competitive proposals but parties purporting to have the requisite credentials to perform these services without substantial duplication of cost or unacceptable delays in fulfilling th e agency's requirements must furnish in writing, factual information, which clearly supports and demonstrates that their recombinant botulinum AB vaccine candidate is sufficiently mature to enter a Phase 2 clinical trial by January 2006, has an existing GM P production facility as well as available capacity to meet the needs of the Phase 2 clinical trials, and a demonstrated manufacturing process scaled to meet production requirements of 1.2 million troop equivalent doses. This information must be e-mailed to Leo Fratis at Leo.Fratis@us.army.mil or faxed to his attention at (301)619-5069 by close of business July 15, 2005. A determination not to compete this proposed action based on any responses to this notice is solely within the discretion of the contrac ting officer. See numbered note 22.
- Record
- SN00819450-W 20050603/050601212425 (fbodaily.com)
- Source
-
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