SPECIAL NOTICE
99 -- Sole Source Modification To N62645-12-C-4068. Manufacturing and Testing pDNA Drug Product (Malaria Vaccine) Appropriate for Preclinical Toxicology and Phase I Clinical Studies.
- Notice Date
- 4/16/2014
- Notice Type
- Special Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
- ZIP Code
- 00000
- Solicitation Number
- N6264511R0028
- Archive Date
- 5/6/2014
- E-Mail Address
-
NMLC RSD Inbox
(NMLC-Research@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command (NMLC) intends to modify contract N62645-12-C-4068 with Aldevron, L.L.C. (3233 15th Street S, Fargo, ND 58104-6147). N62645-12-C-4068 was awarded on an unrestricted (competitive) basis and is for the manufacturing and testing of pDNA Drug Product (Malaria Vaccine) in support of the mission of the malaria department at NMRC. The modification will clarify and in some instances modify aspects of the manufacturing process and materials, to allow Aldevron to continue the manufacturing and testing of pDNA Drug Product. The estimated value of the modification is $633,000.00. The statutory authority permitting other than full and open competition is FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements (10 U.S.C. 2304(c)(1)). Aldevron is currently performing manufacturing in support of NMRC under NMLC ™s contract, N62645-12-C-4068. The capability of NMRC Malaria Department to accomplish its mission hinges on this research effort. The expansion of the contract with Aldevron is necessary in order to provide continuity of research for NMRC research programs. If Aldevron cannot complete the research covered by this contract (via the modification), unacceptable delays to the agency requirements will occur. Specifically, the timely completion of Phase I Clinical trials, of which all malaria department research efforts rely and if subsequently halted or delayed, bring the entire department mission to a halt. Aldevron is the only company that has the capability, the resources, the contacts, and the expertise to provide these critical services and, thereby avoid an unacceptable in an agency requirement that affects all research efforts within the NMRC Malaria Department. This Notice of Intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All capability statements received by 9:00 AM Eastern Time, 02 May 2014 will be considered by the Government. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to NMLC-Research@med.navy.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264511R0028/listing.html)
- Record
- SN03340819-W 20140418/140416235618-9f6b39869986ece4efc597adf3d66ca3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |