A--CBMS-JVAP REQUEST FOR INFORMATION Development of Filovirus Vaccine (s) to Food and Drug Administration (FDA) Approval

This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201e. This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. BACKGROUND: Chemical Biological Medical Systems Joint Vaccine Acquisition Program (CBMS-JVAP) is the DoD organization responsible for developing, producing and stockpiling FDA-licensed vaccine systems to protect the Warfighter from biological agents. The current CBMS-JVAP portfolio includes vaccines at varying stages of clinical development in addition to Food and Drug Administration (FDA) licensed vaccines. RFI number W9113M-10-S-0005 was issued in January for the purpose of collecting information to determine the appropriate contract solution for developing and producing FDA licensed filovirus vaccine(s). The current planned approach is to use smaller contracts, along with Interagency and International Agreements to perform development efforts through completion of a Phase 1 clinical trial. REQUIREMENT: CBMS-JVAP has a new requirement for a pre-exposure prophylaxis filovirus vaccine that provides balanced onset and duration of protection for administration to healthy individuals. The vaccine must provide broad spectrum protection against exposure to multiple species of the Ebola (minimally Sudan and Zaire) and Marburg viruses. Because there are no naturally occurring incidences of aerosolized filovirus exposure, this vaccine is expected to be developed under the Animal Rule (21 CFR 601 Subpart H). PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to seek information and comments from companies that own or have the right/ability to license Intellectual Property (IP) for filovirus vaccines. The Government is seeking to purchase or license the IP for a filovirus vaccine and to develop the selected candidate through a Phase 1 clinical trial(s). Specifically, CBMS-JVAP is seeking filovirus vaccine candidates that have in vivo efficacy data demonstrating protection against Ebola and Marburg viruses and in vivo animal safety/performance data that would suggest safety of the proposed vaccine. As such, the Government is researching information and interest about current industry capabilities via responses to the areas listed below: A. Describe your companys filovirus vaccine candidate that is currently under development. Specifically, identify the candidates capabilities to fulfill the CBRN prophylactic requirement specified above, including: a description of their candidate which clearly supports its prophylactic potential; summary of in vivo efficacy (i.e., route of challenge, challenge species, animal model) and safety data; and a description of the manufacturing process, if available. B. Describe your companys rights and ability to sell or license the filovirus vaccine IP. State your companys interest in selling or licensing the IP. The Government intends to develop the candidate using any means it deems appropriate and may grant sub-licenses or transfer ownership or the license, if applicable, to third parties. Therefore, the Government seeks Unlimited Rights. If your companys interest is in licensing rather than selling the IP, and Unlimited Rights are not an option, explain the Restricted Rights that would potentially be offered to the Government. C. Express level of interest in ongoing participation as a consultant for development of the candidate. D. Indicate company business size (based on the NAICS size standard), business status (i.e., large business, small business, disadvantaged, service-disabled veteran-owned small business, etc.), and date of incorporation. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within 5 days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received within 15 days of issuance of this RFI. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to contact@example.gov; (3) be minimum 11 font on 8.5 X 11 paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 10 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to US Army Space & Missile Defense Command, ATTN: Larry Mize, 64 Thomas Johnson Drive, Frederick, Maryland 21702. Material that is advertisement only in nature is not desired. Contracting Office Address: US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801 Point of Contact(s): contact@example.gov