Replies to post #423683 on NorthWest Biotherapeutics Inc (NWBO)

[Bob_LobLaw]

...and LP not having a vested interest in CRL like she did when she was paying for dedicated space previously...

This terrifies me especially with the recent raises and where that money might be getting allocated. I have a real problem with our CEO also acting as CFO who has other interests that are intertwined with NWBO. We need checks and balances within NWBO to ensure decisions are made in the best interest of NWBO investors as a whole and not affected by Toucan.

[iwasadiver]

FlaskWorks is the KEY PIN. CRL will want to license it if they want in the game. Period. NWBO holds the cards and people simply can’t seem to figure out this simple concept. It’s maddening to me. CRL bought Cognate because of NWBO. There are things lining up behind the scenes that will be PR’d into the weeks and months following TLD. TLD is taking longer than anticipated but nothing will be known, although it’s known, until then

[skitahoe]

Antihama,

I certainly don't know, but I believe the company should be very near to completing their BLA. If I'm correct, by this time I believe they should also have CRL, or someone else, working on preparing for inspections from the regulators they'll be making the vaccine for. While I believe it's CRL who'll be the one, it's not impossible that under confidentiality a partnership that will be triggered by some future event has a partner who'll provide the facility for making the vaccine to serve the market in many countries. If such an arrangement were in place, a BP partner might well make the investment up front to build the needed production facility at no cost to NWBO. On announcement of the partnership all of this information could be revealed.

I'm frankly uncertain if the triggering device to a partnership may be reaching a specific stock price, or a milestone event, which could be as early as TLD to as late as post BLA submission. Clearly if the partner is making the product, inspections would be required with the filing of the BLA or before. I don't know that the FDA won't do this in complete silence if that's what the involved parties request.

The FDA has to disclose that it's being lied about. If a company doesn't believe it's required to announce something they're doing with the FDA, the FDA won't say it's happening unless it's required in their public filings. My point is that investors rarely hear about exchanges between the company and the regulators.

If NWBO had a partner, and if the partner were paying them for achieving certain milestones, than those milestones would be material events, and shareholders need to be notified of material events. Without such payments, it's up to the company what they consider material, as important as filing a BLA is, if they don't deem it to be material, they can avoid issuing a PR if they so choose.

I've been invested in IMGN for decades, I don't think I've yet heard of a trial they initiated announced by them before an investor found it on Clinical Trials. I've often wondered if it would ever be announced if no one found the public filing. In almost every case, updates to clinical trials has been found prior to a company announcement, if it wasn't completely ignored. My point is that the secrecy they seem to operate with is similar to how NWBO is operating. The FDA and other agencies do their jobs, if something belongs in the public domain, it will be put there, but it won't announce them. Investors frequently find filings days, weeks, or even months after they've been put in the public domain, it's a matter of how hard people are looking. I for one occasionally check clinical trials to see if an update has been made, I seriously doubt the company will announce it.

Gary

[biosectinvestor]

Regarding COGNATE... and commercial production.

I do not think those discussing the outstanding Cognate agreement have got the contracts correct. The existing agreement with COGNATE remains in full force for DCVax-L, and they have a new one for DCVax Direct. It is not a commercial production agreement, the provision covering their ultimate agreement to put that in place is in the existing agreement and the existing agreement effectively sets basic terms for negotiating those agreements. There is no severance of agreement or termination of agreement, it is as it was set-up from the beginning, but with these intervening financial settlement to keep the parties agreement effective, basically with no further turmoil. So they did not need to publish a new agreement, that's kind of a tricky way of implying something bad happened that did not happen, and somehow they are nakedly unable to look to CRL/Cognate as originally intended, and THAT is definitely not the case.

In furtherance of that relationship, the parties agreed to an agreement for the production of DCVax-Direct, referenced in a below quote and link. Obviously that has not been necessary to use, but puts to rest the idea that they severed their relationship so as not to have a dedicated cleanroom suite. That agreement provides for such cleanrooms and I'd bet you that if they needed to the parties could rapidly re-dedicate that space to DCVax-L if that made sense to do quickly, by agreement. It also suggests that despite silence, and we know about recent patent developments for Direct, the DCVax Direct product continues moving slowly in the background.

In the most recent 10-K, the company acknowledges that it will rely upon third-party producers potentially to meet production requirements by relevant regulators. However, they clearly intend FIRST to use Sawston and to bring Flaskworks up to production there, asap. So clearly their intention is to rely upon their own facility, and they also will need to agree to a commercial production agreement with ANY and ALL of their contract manufacturers, INCLUDING Advent. All of them are in the same position with regard to COMMERCIAL production. Advent is setting it all up now, for them to execute, and get approved, but upon approval of commercial sales, they will still need to execute in accordance with whatever the requirements are of the relevant territorial/country regulators at that time, which no one, including the company knows exactly. That will all be revealed as they move through their approval process. But they need to have facilities certified and capable of manufacturing, perhaps in different locations around the world, no one knows exactly. So of course, at that time, they will discuss the particulars.

But the notion that there has been some sort of "schism" with Cognate/CRL is clearly, and absolutely WRONG. They will be a part of the potential make-up of their production around the world, as necessary, but not before.


Some of the relevant clauses and agreements:


https://nwbio.com/nw-bio-announces-settlement-with-cognate-bioservices-resolving-past-matters-and-providing-for-restart-of-dcvax-direct-production/

Item 1.01. Entry into a Material Definitive Agreement.

BETHESDA, MD., May 28, 2019 Northwest Biotherapeutics (NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it has entered into a settlement agreement with Cognate BioServices, Inc., resolving past matters and providing for restart of DCVax®-Direct Production.

NW Bio and Cognate agreed upon revised market terms for a new Manufacturing Services Agreement for production of DCVax-Direct to be used by NW Bio in clinical trials. Production of DCVax-Direct is scheduled to start in 10 weeks. Other terms provide for a dedicated cleanroom suite, an upfront payment of $2 million for partial payment of certain past obligations and for restart of new manufacturing of DCVax-Direct, and revised product manufacturing fees which incorporate certain volume discounts.

That is for DCVax Direct, which is not even in trials, but you say they did not want to pay for "dedicated space" for DCVax-L. It contradicts your notion that the basically went their separate ways and wanted not to pay for dedicated space.

Given the old contract, which is the one relevant for DCVax-L, that contract remains in full force and effect unless the parties explicitly terminate the agreement, but they opted just to settle outstanding claims and leave the agreement in full force and effect.

The relevant terms from the DCVax-L agreement are as follows as to terms:

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.

The Agreement was not terminated, instead two settlement agreements were put into place in exchange for Preferred Shares, which were issued and then fully extinguished by the issuance of common shares as pursuant to the conversion rights.

They are substantially the same but for different sets of obligations for 2016 and 2017 respectively.

https://www.sec.gov/Archives/edgar/data/1072379/000114420419017803/tv517288_ex10-74.htm

WHEREAS, pursuant to the existing DCVax®-L and DCVax®-Direct services contracts between NWBio and Cognate (the “Service Contracts”), NWBio owes or will owe Cognate at least Twenty Five Million, Eight Hundred Forty Three Thousand, Five Hundred and Twenty Four Dollars ($25,843,524) for DCVax programs in 2017 (the “2017 Obligations”);

WHEREAS, the Parties agree to a temporary amendment of the Service Contracts as provided in Section 1.1(c) hereof, under which the amounts due from NWBio to Cognate under the Contracts are reduced to Twelve Million, Three Hundred Twenty-Two Thousand, Six Hundred Sixty Four ($12,322,664) for DCVax programs in North America in 2017;

WHEREAS, to date, NWBio has paid Cognate Two Million, Eight Hundred and Two Thousand, Five Hundred Dollars ($2,802,500) for DCVax programs in 2017; and

WHEREAS, on the terms and subject to the conditions set forth herein, (i) NWBio desires to pay and satisfy the 2017 Obligations through an overall settlement comprised partly of cash payments, partly of issuance of preferred stock and warrants, and partly of the 2017 Contract Amendments, and (ii) Cognate is willing to accept such settlement of the 2017 Obligations.

Obligations outstanding were deemed satisfied and cancelled, in terms of the agreement, but the rest of the agreement remains "in full force and effect":

(c) 2017 Contract Amendments. The Service Contracts are hereby amended to cancel and eliminate charges in excess of Twelve Million, Three Hundred Twenty-Two Thousand, Six Hundred Sixty Four ($12,322,664) for DCVax programs in North America in 2017 (the “2017 Contract Amendments”). Pursuant to these 2017 Contract Amendments, the remaining Thirteen Million, Five Hundred Twenty Thousand, Eight Hundred Sixty Dollars ($13,520,860) of 2017 Obligations in excess of the Cash Payments and the Series A Preferred Shares and Warrants, which would have been owed by NWBio to Cognate for 2017 under the Service Contracts in the absence of the 2017 Contract Amendments, are hereby cancelled and deemed satisfied.

(d) No Other Amendments. Except as specifically amended by the 2017 Contract Amendments, the terms and conditions of the Services Contracts remain in full force and effect for DCVax programs in North America.

Just a brief discussion of some of the relevant agreements, as a reference point.