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Alias Born 02/08/2020

Re: None

Tuesday, 03/02/2021 7:56:49 PM

Tuesday, March 02, 2021 7:56:49 PM

Post# of 232885
I'd venture to say this is where we are at now: Definitely a lot for Cytodyn, The FDA and Samsung to discuss.

SBL shall obtain and maintain all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity (other than the Regulatory Approvals, which will be obtained or maintained by Client) that are required to Manufacture and ship the Product at the Facility and perform the Services.



7.3
Regulatory Inspections. SBL shall facilitate on-site inspections of the Facility conducted by Regulatory Authorities. SBL shall notify Client according to the applicable QAG provisions of any contacts or inquiries by the Regulatory Authorities, including inspections, Pre-Approval Inspections, sample requests, and written correspondence and its result, related to the Product, as further defined in the applicable QAG. Any expenses or costs incurred by SBL for such inspections including Pre-Approval Inspections at the Facility shall be borne by Client.
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