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Re: AngeloFoca post# 245200

Monday, 09/23/2019 4:01:01 AM

Monday, September 23, 2019 4:01:01 AM

Post# of 700720
Why would there be communication regarding DCVax-L manufacturing? Cognate has a manufacturing and services agreement from 2014 that is still effective and includes the commercial manufacturing of DCVax-L. There could be negotiations regarding an amendment for commercial scale manufacturing perhaps. If Northwest was going to change their manufacturer, it would require bridging studies to ensure appropriate validation and equivalency, and the last time Northwest did a technology transfer with Fraunhofer, the process took close to 18 months. I understand that it’s just wishful thinking, but do you really think that this transfer would take place during negotiations? That Linda would just hand over her baby based on big pharma’s good faith negotiations? I doubt it. No, a deal would probably had to have been reached at least a year ago, and that would have been before results were known. Again, I doubt it . . . . but keep dreaming, it was entertaining.

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”).
 
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.

    https://www.sec.gov/Archives/edgar/data/1072379/000114420414031414/v377229_ex10-40.htm
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