attachment number 1 – cbli sow w9113m - 10 - c - 0088 attachment number 1 – cbli sow w9113m - 10 - c - 0088 statement of work 2. 1 statement of work ( sow ) ( l. 3. 2. 1 ; m. 3. 2. 2. 1 ) dated august 10, 2010 ( amended june 23, 2011 ) 2. 1 2. 1 cleveland biolabs, inc. ’ s ( cbli ) lead product, cblb502, is currently being tested in phase 1b clinical trials. both preclinical and clinical evidence support cblb502 ’ s use to repair gastrointestinal ( gi ) damage from acute radiation syndrome ( ars ) and to restore the anatomic integrity and normal physiological functioning of the gi tract following radiation exposure. cbli is developing cblb502 as a post - exposure medical radiation countermeasure ( mrc ) in the treatment of ionizing radiation ( ir ) injury, specifically the gi subsyndrome of ars ( gi - ars ). further, our mrc will decrease incapacity of affected military forces following exposure to ir such that they can maintain operational effectiveness within a contaminated area, regardless of radiation source. the completed work items listed in the statement of objectives ( soo ) are included in this sow for completeness and are indicated in italic below. technology development phase cbli shall arrange for, supervise, and provide all the human resources, facilities and expertise to prepare, submit and maintain an ind for ars. these activities include, but are not limited to, the activities listed below. c. 3. 1. 1. cbli completed cgmp compliant ( 21 cfr part 210 and 211 ) small - scale manufacturing process development and qualification for cblb502 and currently manufactures cblb502 in a cgmp compliant manufacturing facility operated by synco bio partners n. v. two small - scale ( 5l ) consistency batches with purity > 96 % ( lots 09 - cob4 - 3040 - i01 and 09 - cob4 - 3040 - i02 ) were successfully manufactured in nov - dec 2009. c. 3. 1. 2. cbli successfully manufactured a cgmp compliant lot of cblb502 for use in nonclinical toxicology and phase 1 studies. this lot of cblb502 was