A--Notice of Intent to Sole Source with DVC for manufacturing, clinical and non-clinical studies from a candidate Cohn Fraction IV-4 paste source and to field the candidate doses of the product under an expanded access protocol

The Army Contracting Command - Aberdeen Proving Ground on behalf of the Chemical Defense Pharmaceuticals (CDP) Joint Product Management Office intends to procure, on a sole source basis, manufacturing, clinical studies, and non-clinical studies from a candidate Cohn Fraction IV-4 paste source and to field the candidate doses of the product under an expanded access protocol. The intended contractor is DynPort Vaccine Company (DVC), 64 Thomas Johnson Drive, Frederick, MD 21702. DVC is the only known source that, through an already existing subcontract with Therapure BioPharma Inc (TBI), has: technology transferred the manufacturing process; validated the technology transfer at the intermediate manufacturing scale; and establishing a large scale manufacturing process for HuBChE that is cGMP compliant. Additionally, DVC has: designed Phase 1 and Phase 2 clinical studies to demonstrate human safety of HuBChE; conducted a Type C meeting with the FDA and received agreement on the challenge agent for non-clinical studies; conducted a Type B meeting with the FDA and received agreement on the animal species for non-clinical studies and strategy to predict human benefit of HuBChE. DVC is the sponsor for the Investigational New Drug application for HuBChE and they will allow crossing referencing of the data from the expanded access protocol to support FDA licensure of the product. A cost-plus-fixed-fee contract will be issued for program management, manufacturing, clinical studies, and non-clinical studies. The statutory authority permitting acquisition of these items by other than full and open competition is 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1(b)(1)(ii)(A)(B), Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements. This is not a request for competitive proposals. Parties purporting to have the requisite credentials and licensing to provide these supplies without unacceptable delays in fulfilling the agency's requirements must furnish, in writing, factual information, which clearly supports and demonstrates that their facility is sufficiently able to perform the aforementioned work, no later than December 15, 2014. Please direct any questions regarding this announcement to Mr. Leo Fratis, Contracting Officer, +1 (555) 000-0000 e-mail: contact@example.gov. A determination not to compete this proposed action based on any responses to this notice is solely within the discretion of the Contracting Officer. See numbered note 22.