Friday, February 17, 2017 4:17:08 PM
Cognate agreed to provide a *redacted* number of manufacturing suites.
In an agreement filed with the SEC in August of last year they agreed:
With [***] Asterias Suites in full operation, the maximum production capacity of AST-VAC1 will be [***]. Our current understanding of the AST-VAC1 process leads us to believe that [***] is the maximum Batch capacity per each manufacturing suite without the incorporation of process improvements and/or additional understanding of the manufacturing process. This understanding may change [***] during the normal course of manufacturing AST-VAC1, or at any point during the term of performance under this SOW 2. Additionally, Cognate understands that Asterias will be performing additional diligence to determine projected rates of enrollment in the AST-VAC1 clinical trial in parallel with the performance of the activities under SOW 1, and that these activities may result in increases to Asterias’ projected maximum production capacity requirements; provided, however, that in no event will [***] be reduced including if Asterias enrolls less patients than projected. Subject to the foregoing proviso, this Section 2.3 of this SOW 2 may change, or need to be changed, if Cognate or Asterias determines such modifications are appropriate, subject to mutual written approval of any such changes, not to be unreasonably withheld or delayed.
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