NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

expired? I believe technically they still have a manufacturing agreement with Cognate. Northwest Bio was in breach, but Cognate didn’t terminate the agreement, instead they reached a settlement. But yes they will have to negotiate a new agreement for the commercial production of DCVax-L, which curiously hasn’t been announced. It does make me wonder how long the negotiations between Cognate and Charles River has been on-going, and when Northwest Bio shared the results with Cognate. While Northwest Bio has certainly had the time to switch manufacturers and run equivalency studies, they’ve made zero indication that they would, or have.

Linda Powers, CEO of NW Bio, observed, “We are happy to have  resolved the past contractual issues and reached agreement on terms for a new manufacturing relationship with Cognate, putting us both in a position to move forward with a clean slate.  We believe this is good for NW Bio and Cognate, good for our patients, and good for our shareholders.  We greatly appreciate Cognate’s belief in NW Bio and its DCVax technology, and we look forward to a strengthened and reinvigorated partnership with Cognate as we move forward on our exciting programs.” -May 28, 2019

From the 10-K:

We negotiated a new agreement with Cognate for production of DCVax-Direct products in 2019, and we will need to negotiate a new agreement with Cognate in 2020 for production of DCVax-L products for commercial purposes and new programs. We also need to negotiate an agreement (Statement of Work, or SOW) with Advent relating to the design, development, buildout, testing, regulatory inspection and regulatory certification of a new manufacturing facility in Sawston, UK, and a new agreement with Advent for production of DCVax-L products in that new facility when it is ready. We also need to negotiate an agreement with Advent for production of DCVax-Direct in the UK. There can be no assurance that we will be able to negotiate favorable terms in each of these agreements. Following negotiations, if it is necessary or desirable to change our facility design and development arrangements or our manufacturing arrangements, that could involve increased facility costs and/or increased costs related to manufacturing of our products, and could result in delays in our programs or applications for various regulatory approvals.

DCVAX®-L MANUFACTURING AND SERVICES AGREEMENT

This Amended and Restated Services Agreement (this “Agreement”), originally dated April 1, 2011 is entered into, effective as of January 17, 2014 (the “Effective Date”), by and between Cognate BioServices, a Delaware corporation (Cognate”), and Northwest Biotherapeutics, a Delaware corporation (“NW Bio”).
 

SECTION 6:    TERM AND TERMINATION
 
6.1    Term
 
This Agreement will remain in force until the later of seven (7) years from the Effective Date (the “Term”) or five (5) years after the first commercial sales of DCVax®-L Products pursuant to a Biologics License Application or marketing authorization (not a compassionate use, hospital exemption or similar authorization), unless terminated earlier pursuant to Section 6.2

6.2    Termination
 
Either party may terminate this Agreement in the event of a material breach by the other party which remains uncured after notice of such breach for a period of thirty (30) days in the case of a monetary breach, or a period of one hundred twenty (120) days in the case of a non-monetary breach that is material to the contract taken as a whole
  

Confidential treatment required; certain information omitted and filed separately with the SEC.
 

 
8.8    Successors and Assigns

 
Except as otherwise expressly provided herein, the provisions hereof will be binding upon, and inure to the benefit of the respective successors, assigns, heirs, executors and administrators of the parties hereto. Neither party hereto may transfer all or any portion of its rights under this Agreement to a third party other than an affiliate without the prior written consent of the other party hereto.