This is a Notice of Intent to issue a Sole Source award on the basis of other than full and open competition in accordance with the Federal Acquisition Regulation (FAR) 6.302-1(a)(2) - Only one responsible source and no other supplies or services will satisfy agency requirements. This is not a Request for Quotes or Proposals. No contract award will be made on the basis of response to this notice. The purpose of this Notice is to allow interested parties to assert and explain their capability to perform the work described. The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Sole Source Award, as a logical follow-on, Fertin Pharma A/S, Dandyvej 19, Vejke, 7100, Denmark. Fertin Pharma A/S has been identified as the only company who can develop the technical batches and the current Good Manufacturing Practice (cGMP) to manufacture antiplaque chewing gum (APCG). Fertin Pharma was originally awarded a contract for the development, preparation, cGMP manufacture and testing of antiplaque chewing gum containing antimicrobial peptides for Phase I and 2 Clinical Trials. Both the technical and cGMP APCG are manufactured by Fertin Pharma. This award will be the final phase of the study to take the product to manufacturing capability. The total award amount is estimated to be $649,000.00. Contractors who can provide USAMRAA with the required services are invited to electronically submit responses that demonstrate clear and convincing evidence that their firm will satisfy the Government's technical requirement for development, preparation, cGMP manufacture and testing of antiplaque chewing gum containing antimicrobial peptides. Responses should appear on company letterhead and include, at minimum, affirmation of active registration in the System for Award Management (SAM), your qualifications and any applicable pricing data or information. All responses should include a point of contact, telephone number, and e-mail address. Additionally, respondents should indicate whether they are a large business, small business, small disadvantaged business, 8(a) concern, woman-owned small business, HUBZone, service disabled veteran-owned small business, or qualify as socially or economically disadvantaged and whether they are U.S or foreign owned. Responses to this notice will be used to determine the availability of this type of service. All responsible sources may respond to this notice and all responses will be considered by the agency. All responses should be furnished electronically to the Contract Specialist by e-mail at
[email protected] by NO LATER THAN 3:00 PM Eastern Standard Time (EST) on May 21, 2015. Additional Info: United States Army Medical Research Acquisition Activity Contracting Office Address: US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014 Point of Contact(s): Katrina Nelson, 301-619-2458 US Army Medical Research Acquisition Activity