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1995S-0316
RPT 277
Volume 214

Cover Letter, Correspondence between CFSAN and Barnes & Thornburg

Attachment A - U.S. Patent Number 5,364,788

Attachment B - European Patent Number 92111072.2

Attachment C - Product Composition

Attachment D - Toxicity Test Result

Attachment E - Certificate of Product Registration

Attachment F - "Old and New Discovery of Bacterium with Strong Immunity Activating Power and Its Applications," Presentation dated February 22, 2005 of Mr. Masashi Kito, President of BMI, a parent company of BAU Inc. to the Highly Advanced Medical Technology Study Group.

Attachment G - Masashi Kite, "Life Force Bacillus" published in the November 2004 issue of the personal health magazine Hatsuratsu genki. Published Material

Attachment H - Hiroiku Ueno, "DB 9011, from the bacillus subtillis group, boosts your immune system, helping speed the recovery period after cancer treatment and surgery, and can help prevent cancer recurrence" published in the February 2005 issue of the monthly magazine Gan (Cancer). Published Material

Attachment I - Jun Ishikawa, "Immune Activation Effects of DB-9011 on Dogs and Cats" (October 3, 1996). Published Material

Attachment J - Yoko Hrano et al., "Preventative Effect ofTreatment of Bacillus Subtilis DB-9011 on Dogs of which Cellular Immune Function is Decreased by Surgical Operation” (October 30, 1996).

Attachment K - Redacted

Attachment L - Redacted

Attachment M - Yoshiya Asano et al., "Establishment of Monoclonal Antibodies Specific for Bacillus subtilis DB9011," Biosci. Biotechnol. Biochem., 64 (3), 652-656 (2000). Published Material

Attachment N - Signature Page


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