AWARD
65 -- Ixiaro Vaccine - Signed J&A
- Notice Date
- 7/27/2009
- Notice Type
- Award Notice
- Contracting Office
- U.S. Department of State, Office of Logistics Management, Acquisition Management, P.O. Box 9115, Rosslyn Station, Arlington, Virginia, 22219
- ZIP Code
- 22219
- Solicitation Number
- SAQMMA09M1441
- Archive Date
- 8/8/2009
- Point of Contact
- Cynthia I Harper, Phone: 7038756218
- E-Mail Address
-
harperc@state.gov
(harperc@state.gov)
- Small Business Set-Aside
- N/A
- Award Number
- SAQMMA09M1441
- Award Date
- 7/24/2009
- Awardee
- NOVARTIS VACCINES AND DIAGNOSTIC, INC, 4560 HORTON STREET<br />, EMERYVILLE, California 94608-2916, United States
- Award Amount
- $72,150.00
- Description
- This is the signed J&A for a sole source to Novartis Vaccines and Diagnostics, Inc. who is the manufacturer for this vaccine. JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION SOLE SOURCE OFFICE OF MEDICAL SERVICES, WASHINGTON, DC (1)Identification of the agency and the contracting activity, and specific identification of the document as a ‘SOLE SOURCE’ justification. Department of State Office of Medical Services 2401 E Street, NW Washington, DC 20522-0101 Contact – James M. Walters, (202) 663-1932 MED/EX/MSS (2)Nature and/or description of the action being approved. Sole Source Justification for the emergency purchase of the new Japanese Encephalitis (JE) vaccine called Ixiaro which is solely distributed by Novartis. Novartis is the manufacturer for the Ixiaro vaccine and was approved by the FDA in March 30, 2009. (3)A description of the supplies or services required to meet the agency’s needs (including the estimated value). 370 packages of Ixiaro vaccine are needed. With what is currently on hand, this quantity will be sufficient to inoculate 200 DOS Foreign Service Officers and family members being posted to areas where the JE disease in prevalent. Estimated value for the vaccines is $72,150.00. (4)An identification of the statutory authority permitting other than full and open competition. 41 USC 253(c)(2), FAR 6.302-2, Unusual and compelling urgency. The Department’s need for Ixiaro vaccine is of such an unusual and compelling urgency that the Government would be seriously injured in the event of a delay in award of a contract. (5)A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited. Novartis is the sole authorized distributor of the FDA approved JE vaccine Ixiaro in the United States. It is also the only commercial source of this drug. Market research from GSA Advantage shows several vendors who hold the schedule for pharmaceutical products; however, there is only one or two that list they handle this vaccine, Ixiaro. Sole Source justification is required as this vaccine, Ixiaro is the only one available that is used to prevent the Japanese Encephalitis (JE) and the manufacturer is Novartis. JE is potentially life-threatening for travelers as well as those who are stationed in high potential areas of Asia from the Department of State and their families. (6)A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies. Novartis is the only company able to supply Ixiaro at this time. The Department of Health and Human Services (HHS) Supply Service Center at Perry Point Maryland was contacted on June 19th, and had none available. Amerisource-Bergen, the pharmaceutical “Prime Vendor” used by MED Washington, was also checked and is unable to supply any Ixiaro. FAR part 5.202 (2) applies: The contract action is being made under unusual and compelling urgency as stated in FAR 6.302-2 and the government would be seriously injured if the Department complies with the time periods specified in 5.203. (7)A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. Novartis has established the Ixiaro selling price of $195 per package. This is the same price it is offering to all its customers. There is no alternative JE vaccine product available since production ceased on Sanofi-Pasteur’s JE-VAX. When it was available JE-VAX sold for $275.75 per package under FSS V797P-5949X. (8)A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted. Research was conducted and it was determined that Novartis is the only vendor that will be able to supply the JE vaccine Ixiaro. Market research from GSA Advantage shows several vendors who hold the schedule for pharmaceutical products; however, there is only one or two that list they handle this vaccine, Ixiaro. Information from the Novartis website affirms that this is the only vaccine known at this time to immunize against JE. The vaccine is provided as a ready-to-use liquid formation in pre-filled syringes and is administered in two doses 28 days apart for an active immunization. (9)Any other facts supporting the use of other than full and open competition. IRT: FAR 6.302-2, Unusual and compelling urgency: It is essential that an inventory of Ixiaro be purchased to be used to protect the health and wellbeing of U.S. Diplomats and their family members being assigned to areas of the world where JE is endemic. JE is an acute inflammatory condition of the brain and spinal cord. This virus is life threatening to those who are in these regions of Asia. The transmission of JE is linked to the seasonality of the mosquitoes in these areas. Many of these areas are tropical climates which hold a potential for year round transmission and elsewhere, peak periods of increased viral transmission follows monsoon seasons. AG Novatis and Intercell have strategic alliance that provides Novartis with the commercialization rights to Ixiaro. (10) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition. Novartis is the only authorized distributor of Ixiaro in the USA at this present time. (11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. Since there is no other company that provides this vaccine at the present time, we do not for see any problems with competition issues. (12)Contracting officer certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.
- Web Link
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- Record
- SN01889055-W 20090729/090728000327-7fd2c25786d768c4c782981471d02197 (fbodaily.com)
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