Avid Bioservices Inc (CDMO)

[r622102675]

Page 30 of the pdf complaint... 154. According to CW4, the SOPs, Clinical Protocol and Case Report Forms
cannot be obtained from the FDA with a Freedom of Information Act (“FOIA”)
request as they are considered proprietary.
155. Plaintiff Fahey made a FOIA demand upon the FDA to obtain the
SOPs, the Clinical Protocol and the Case Report Forms on the Phase II Trial, but the
FDA refused to produce them. ...r