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antihama

12/30/21 8:14 AM

#430686 RE: MI Dendream #430663

Any SOPs or validation process docs that would impact NWBO's product would need to get approval or buy-in :) from NWBO and that would be spelled out in the Quality Technical Agreement that is addended to the Contract Agreement. So NWBO might not own the documents per se but then again they have control in the creation or revision to any of those documents.
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Bacchus1

12/30/21 1:26 PM

#430821 RE: MI Dendream #430663

Advent will have put the SOPs together and overseen all validation. These documents will be owned by Advent not NWBO