NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Advent is the facilities manager, but the GMP certification ultimately belongs to the facility. Advent is just one input into that certification. If the certification “belonged” to advent then the certification for the London facility would be theirs already, and they’d simply move it to Sawston. They do not own Sawston or the production there.

In this case, the facility and all of the documentation are being created on contract for this facility/ factory. A CDMO has been hired and contracted to run that process. The financial statement even discusses that that will last until the parties arrange a transition. What does that mean, that anyone with personnel qualified at some point, including NWBO, can take over the process so long as they then continue to follow the procedures that the two parties have created (Advent did not create DCVax and is not responsible for its creation, as intellectual property, patents, procedures), Advent doing so under contract. When such procedures are created they cover everything like where source materials come from, how they are kept, how people are trained, their qualifications and how their training is maintained. At the end of the day, all of that additional operational detail, the manuals and procedures belong to NWBO, and if Advent moves on, NWBO can slot in another CDMO, or itself.

The complication is that advent will get to use the facility and it’s certification for its other customers upon NWBO’s consent. But likely that transition arrangement under the contract will cover such work, and how it can be moved without disrupting Advent’s business as well. This is how contracts are negotiated.

CRL’s and Cognate’s facilities belong to them. Different situation. They are owners and managers of their own facilities.