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lrdpdx77

12/29/21 4:22 PM

#430582 RE: dennisdave #430520

Advent already had a GMP license to manufacture DC-Vax at the small London facility. They needed to apply for a new license to provide the same services at Sawston. So yes the license is in their name as certicate holder for the Sawston location. If NWBO terminates the contract Advent has no right to manufacture DC-Vax. NWBO could hire a new CMO to operate the Sawston facility. The new CMO would need to get GMP approval in this instance for Sawston

biosectinvestor

12/30/21 2:24 AM

#430670 RE: dennisdave #430520

They are a contract manufacturer and BY contract are the operator of the plant. The contracts provide if either party terminates, for a year period for the orderly transfer.

All the procedures and process and facilities including all of the fixtures generally belong to the contract holder, which is NWBO. The key ingredients Advent provided are 1) the expertise to build the facility and create GMP procedures and documentation, training ext.; and 2) personnel by contract to do this process in the factory. They also have some ability at NWBO’s option and under contractual control, to utilize the factory on a basis that generates revenues for both parties until the NWBO scales commercially, which is symbiotic.

However, the party holding the license in this case is a contract party, they can be replaced by another contract party and the transition can be completed in normal
Times efficiently, and most likely they regulator, in this case the MHRA is going to want to ensure that procedures continue to be competently manage Ana that competent persons remain in charge.

How that might go is they might either have a buyer that already has such facilities and personnel; or they might recruit new people; or more easily NWBO might takeover them employment contracts if employees hired by Advent for a fee, just like headhunter firms; or NEBO may have hired people along the way as they set-up their Flaskworks systems and those people would be ready to take over and scale the whole thing up. There are innumerable variations and combinations that make taking over from a sub-contractor quite easy.

Have you never heard of sub-contracting before? Is this a new business concept for you?