Notice of Intent to Sole Source: Solvent Detergent Spray Dried Plasma

The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to award a sole source contract under the authority of 6.302-1(a)(2) to Entegrion, Inc., 79 T W Alexander STE 200, Durham, NC 27709 for the performance of continued research and development efforts in support of the Hemorrhage Control and Resuscitation Steering Committee, Combat Casualty Care Research Program (Joint Program Committee-6 (JPC-6)) and the Naval Medical Research Center.

The contract award is intended to build upon Entegrion's success in Phase 1 and Phase 2 clinical trials to develop a spray dried, solvent detergent pathogen inactivated, lipid reduced, human-derived plasma, manufactured under cGMP, with the ultimate goal of FDA approval. The new contract is intended to provide funding to continue their ongoing efforts in Phase 2 clinical trials.

The product tested in ongoing clinical trials is Resusix. Resusix® is an Entegrion patented product (Patent ID: CA2757961 A1) developed as a result of competitive selection, in response to the Naval Health Research Center (NHRC) Broad Agency Announcement (BAA) #11-001, under Research Area H.(b): Biomedical Translational Initiative, Blood substitutes: Human derived, pathogen inert, temperature stable, lipid reduced plasma products for trauma-induced coagulopathy.

The estimated value of this contract is $50 million, inclusive of an optional period of performance. The period of performance for this contract is anticipated to be a three-year base period of performance and one, three year optional period.

Based on these unique capabilities and the previous work done with Entegrion, Inc., Entegrion, Inc., is the only company capable of meeting the Government's requirements. 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 and other information sufficient to determine capability to perform the proposed contract effort.

All capability statements received by 10:00AM local Time on December 23, 2015, will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to wayne.a.medina2.civ@mail.mil.