Donors

Seed Biotech Inc. uses select FDA-registered tissue recovery partners to collect donor tissue intended for transplantation. Subsequent to the conduct of a comprehensive review of the donor of this allograft, informed consent, medical history risk assessment interview, physical examination, available medical records, collection transport records, collection microbiology culture results, and infectious disease test results, the medical director of Seed Biotech Inc., a licensed physician determined that the donor of this allograft tissue satisfies the medical eligibility requirements identified in Seed Biotech Inc., Donor Acceptance Criteria Policy which exceeds requirements established by the Federal Drug Administration and as specified in the AATB standards. Prior to processing, blood specimens collected at the time of tissue recovery from the donor of this allograft tissue were tested for the relevant communicable disease agents found in Table 1, and nonreactive or negative test results were obtained. All serological and microbiological testing was conducted using FDA-approved tests. Communicable disease testing was performed by a CLIA-certified laboratory registered with the FDA for donor testing. In addition to the preclinical safety testing, lot-to-lot bioanalytical testing, donor screening, and testing process validation, a comprehensive quality assurance review of processing packaging records, finished tissue microbiology cultures, and the labeling gamma irradiation records associated with the donor of this allograft was performed, prior to this allograft being released for distribution. The names and addresses of Seed Biotech Inc., tissue recovery partners, and clinical testing service providers, the testing and interpretation of all donor screening and infectious disease test results, the list of the documents reviewed as part of this donor's relevant medical records, and the name of the person determining the suitability of this donated human tissue are on file at Seed Biotech Inc. and are available upon request.