1. Summary/Introduction a) The Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, is the contracting activity. b) The acquisition will result in an Indefinite Quantity Contract for tableted Adenovirus Vaccine Types 4 and 7. c) The total duration of this contract will be for a one-year base period and four (4) one-year option periods. [redacted] d) The statutory authority for Other than Full and Open Competition is 10 U.S.C. 2304(c)(1): only one responsible source and no other supplies or services will satisfy agency requirements. 2. Description of Agency's Need (10 U.S.C. 2304(f)(3)(a)): I) Background a) Adenoviruses are common pathogens that often are associated with respiratory and gastrointestinal illness in young persons. Adenovirus serotypes 4 and 7 have caused outbreaks of respiratory illness in young adults in basic military training. Beginning in 1971, all military recruits received oral, live, enteric-coated vaccines that were licensed by the Food and Drug Administration (FDA) as safe and effective in preventing illness from adenovirus serotypes 4 and 7. In 1996, the sole manufacturer, Wyeth Laboratories, ceased production of adenoviral vaccines. [redacted] As supplies dwindled during the next few years, outbreaks of adenoviral respiratory illness re-emerged in military settings. The Government currently monitors infection rates on a weekly basis as reported by the Febrile Respiratory Illness Surveillance published by the Naval Health Research Center, San Diego. Based on recent surveillance statistics, the infection rate has ranged between 13,320 and 15,120 cases per year. b) Since the cessation of production of the vaccine in 1996, the Department of Defense (DoD) has renewed efforts at securing a supplier. In 2001, a developmental contract was issued to Barr Laboratories by the U.S. Army Medical Research Acquisition Activity (USAMRAA) for the purpose of restoring adenovirus vaccine production capability. [redacted] Barr's offer was rated the best value to the Government based on factors outlined in the solicitation. c) An award for the low-rate initial production (LRIP) contract was issued to Barr Laboratories in September 2010 by USAMRAA under authority of 10 U.S.C. 2304(c)(1). The contract has an effective date of September 24, 2010 for an 18-month period (ending March 24, 2012). The contract was for a fixed quantity of 270,000 doses [redacted]. A unit dose consists of one (1) tablet each of type 4 and type 7 adenovirus vaccine. The contract calls for delivery of 120,000 doses by July 24, 2011 (i.e. 10 months after award), with the balance of 150,000 doses by March 24, 2012. d) The LRIP contract requires Barr to deliver the vaccine to military recruitment centers throughout the United States. All the military services will be users of the vaccine, not just the Army. The DLA contract is expected to be awarded by September 2012. USAMRAA is currently preparing to award a bridge contract in the event of a gap in supply between the LRIP contract and the DLA contract. If delivery occurs at the same rate under the DLA contract as under the LRIP contract, the first deliveries won't occur until July 2013 (i.e. 10 months after anticipated award date). The USAMRAA bridge contract is expected to fill this gap and include option periods, which may or may not be exercised, depending on whether the DLA contract is in place. There is no expectation of overstocking for this vaccine due to the fact that the DLA contract will be an indefinite quantity type contract with a guaranteed minimum low enough to allow for flexible ordering. The vaccine is required to have a minimum shelf life of 12 months upon delivery to the Government. II). DLA Acquisition - Description of Need/Supplies a) For the DLA acquisition, an indefinite quantity type contract is planned, with an estimated annual requirement of 270,000 doses [redacted]. The guaranteed minimum quantity per year is set at 150,000 doses and the annual maximum quantity is 335,000 doses. The total duration of this contract will be for a one-year base period and four (4) one-year option periods. [redacted] b) [redacted] c) There is no surge requirement. The adenovirus is administered only to Service inductees, generally not to active duty personnel. The maximum amount is considered sufficient to cover potential increases in the annual number of recruits. 3. Authority for Other than Full and Open Competition (10 U.S.C. 2304(f)(3)(B): a) The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1): only one responsible source and no other supplies or services will satisfy agency requirements. As a result of the aforesaid developmental contract, Barr Laboratories, a wholly owned subsidiary of Teva Pharmaceutical, is the only known source with the facilities, knowledge, technical data, and manufacturing capability necessary to provide the adenovirus vaccine. Barr was acquired by Teva Pharmaceutical Industries, Ltd. (Israel) in December 2008. Barr is also the only known firm to have undergone the clinical trials and product testing necessary to attain a Biologics License Agreement (BLA) for the manufacture and sale of adenovirus vaccine. Official approval of this BLA was granted to Teva by the FDA on March 16, 2011. USAMRAA will no longer contract with Barr for the adenovirus vaccine upon completion of their bridge contract, which is expected to follow the initial LRIP contract. b) The lack of additional sources is also due to the fact that DoD is currently the only customer for this type of vaccine and the demand level is not sufficient to support multiple competing sources. 4. Price/Cost Considerations (10 U.S.C. 2304(f)(3)(c)): As the Contracting Officer, I anticipate that the cost to the Government will be fair and reasonable based on an analysis of Barr's cost and pricing data to be submitted with their proposal. Currently, there is no commercial market for the adenovirus vaccine and DoD will be the only customer. 5. Market Research/Efforts to Obtain Competition (10 U.S.C. 2304(f)(3)(D) & (E)): a) [redacted] In addition to describing the current requirements, we stipulated that a) no Government facilities would be made available for production use, and b) FDA approval of the vaccine would be required before award. [redacted] b) According to the website Clinicaltrials.gov, there are no current public clinical trials for the purpose of marketing a vaccine for adenovirus type 4 or type 7. This website indicates firms that are conducting clinical trials for the purpose of medical research or attaining FDA approval, although it may not include all such efforts. c) [redacted] d) In accordance with FAR 6.302-1(d)(2), this requirement was synopsized in FedBizOpps on February 8, 2011. Additionally, a Sources Sought notice was published in FedBizOpps on March 10, 2011 describing the requirements and requesting information from potential sources. This justification will also be made available for public inspection after award in accordance with FAR 6.305. 6. Actions Being Taken to Overcome Barriers to Competition (10 U.S.C. 2304 (f)(3)(F): a) There is no commercial market for an adenovirus vaccine. There may be non-Government uses of the vaccine, such as for a college or university student body or a prison population; however, there is no current demand for using the vaccine in these situations. b) The DoD demand level for this vaccine is considered insufficient to sustain more than one supplier. The expenses of capital and technological investments, and compliance with FDA regulations and licensure are prohibitive barriers to entry in this market. There are no known firms other than Barr that have gone through this process. All previous offerors and suppliers of this vaccine, as well as identified producers of the virus itself, will be solicited for this requirement. In addition, market research will be conducted prior to option exercise in an effort to identify new sources. c) I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief. _______________________________ NEIL McAVINUE Date Contracting Officer
