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B-402576 1 (2010-06-08)

handle is hein.gao/gaobadbio0001 and id is 1 raw text is: G A 0Comptroller General Accountability * Integrity * Reliability of the United States United States Government Accountability Office DOCUMENT FOR PUBLIC RELEASE Washington, DC 20548 The decision issued on the date below was subject to a GAO Protective Order. This redacted version has been approved for public release. Decision Matter of: Emergent BioSolutions Inc. File: B-402576 Date: June 8, 2010 Jason A. Carey, Esq., Dana B. Pashkoff, Esq., and Susan Corts Hill, Esq., McKenna Long & Aldridge LLP, for the protester. Philip J. Davis, Esq., John R. Prairie, Esq., and Brian G. Walsh, Esq., Wiley Rein LLP, for Pharm-Athene, Inc., an intervenor. Christopher M. Johnson, Esq., and Jonathan A. Baker, Esq., Department of Health and Human Services, for the agency. Louis A. Chiarella, Esq., and Christine S. Melody, Esq., Office of the General Counsel, GAO, participated in the preparation of the decision. DIGEST Protest that modification of contract for advanced development, testing, and production of anthrax vaccine was outside the scope of the original contract is denied where modification did not substantially alter the scope of work anticipated by the underlying solicitation. DECISION Emergent BioSolutions Inc., of Rockville, Maryland, protests the issuance of modification 0018 to contract No. NO1-Al-30052 by the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), to Pharm-Athene, Inc., of Annapolis, Maryland, regarding the development and manufacture of a recombinant protective antigen (rPA) anthrax vaccine. 1 The term recombinant refers to a product created using a genetic engineering technology in which one or more pieces of DNA are combined together. A protective antigen is a biochemical that produces an immunologic response that then protects animals or humans against challenges from the infectious agent. PharmAthene Comments, Apr. 12, 2010, attach. 2, GAO, Project BioShield: Actions Needed to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine, GAO-08-88 (Washington, D.C.: Oct. 23, 2007) (GAO Project BioShield Report), at 1 n. 1; Agency Report (AR), Tab 2, Project Officer's Declaration, Apr. 1, 2010, at 2.

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