Exhibit 10.43


 


Portions of this exhibit marked [*] are requested
to be treated confidentially.


 


MANUFACTURING EXPANSION SERVICES AGREEMENT


 


This Services Agreement
(this “Agreement”) 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”).


 


RECITALS


 


WHEREAS, NW Bio is in
the business of developing immune cell therapies for cancer, and Cognate is in the business of manufacturing clinical grade cellular
products on a contract services basis;


 


WHEREAS, NW Bio and Cognate
previously entered into a Services Agreement for the production of NW Bio’s DCVax® Products by Cognate (the “Prior
Services Agreement”) and the Conversion and Lock-Up Agreement (the “Lock-Up Agreement”);


 


WHEREAS, Cognate has dedicated
cGMP facilities and other facilities to NW Bio programs, and conducted all of NW Bio’s physical operations including all
collections of patient tumor tissues and leukapheresis materials from clinical sites, all manufacturing, quality control, cryopreservation
and banking of all DCVax® Products, and all distribution and logistics to the point of care throughout the US, as well as management
and oversight of all such functions in Europe and Israel;


 


WHEREAS, both the quantity
and the scope of services NW Bio has requested that Cognate provide greatly exceed the maximum scope and amounts contemplated or
provided for in the Prior Services Agreement [*];


 


WHEREAS, NW Bio desires
[*];


 


WHEREAS, NW Bio has requested
Cognate to provide all necessary services to identify and evaluate potential sites for the manufacturing expansion [*];


 


[*];


 


[*];


 


WHEREAS, the parties also
desire to update and reformulate their existing Prior Services Agreement into a more comprehensive and complete set of four agreements
including (i) this Manufacturing Expansion Services Agreement; (ii) a DCVax-L Manufacturing and Services Agreement, (iii) a new
DCVax-Direct Manufacturing and Services Agreement, and (iv) a new Ancilliary Services Agreement.


 


 


 





[*] Confidential treatment requested; certain information omitted
and filed separately with the SEC.









    	 



    	 



    

  


AGREEMENT


 


Now,
Therefore, in consideration of the foregoing recitals and the mutual promises, representations, warranties, and covenants
hereinafter set forth, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged,
the parties hereby agree as follows:


 


SECTION 1:    SERVICES


 


1.1    Scope
of Services.


 


Cognate will provide
to NW Bio, on the terms and conditions set forth herein, the services required to identify, select, develop, obtain regulatory
approvals for, and put into operation [*] expanded manufacturing facilities (collectively, the “Manufacturing Expansion Services”
or the “Services”). Cognate will engage experts and other third parties as appropriate to assist with such services
[*]. Such Services will include the following:


 


1.1.1    Identification,
Evaluation, Selection and Acquisition of [*] Sites: Cognate will identify [*] sites which may be suitable for, or may be adapted
for, manufacturing of DCVax® Products. Cognate will will undertake evaluation of such [*] sites [*].


 


1.1.2    Design
and Engineering: For the [*] sites that are acquired, Cognate will develop the facility layout and design, [*].


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


1.1.8    Other
Services: In addition to the services provided for under the foregoing Sections 1.1.1 through 1.1.7, the parties will determine
any other services which may be required for manufacturing expansion, and the parties will develop work plans, timelines and budgets
for execution of such other services by Cognate pursuant to this Agreement.


 


1.2    Manufacturing
Expansion Locations


 


The parties currently
anticipate that the manufacturing of DCVax® Products will be structured on a regional basis, [*]. This regional approach will
enable the tumor tissue collections and leukapheresis collections to reach the manufacturing facilities within the necessary time
windows, while also enabling efficient operations with economies of scale.


 


 





[*] Confidential treatment requested; certain information omitted
and filed separately with the SEC.









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[*]


 


[*]


 


[*]


 


[*]


 


SECTION 2:    PAYMENTS


 


2.1    Payment
Terms for Manufacturing Expansion Services 


 


2.1.1 The parties
will determine and agree upon the payment terms for the Manufacturing Expansion Services described in Section 1 hereof, subject
to the provisions of Section 2.5.2 hereof (for payment of at least half of all Ancillary Services Invoices in stock, with fifty
percent (50%) warrant coverage, [*], and such payment terms will be included in the sub-agreements or work orders for such Services
that are to be attached hereto as Exhibits. The parties will negotiate and decide all such payment terms in good faith on market
based terms, with due consideration of any special factors, such as accelerated timetables and related extra costs and difficulties.


 


2.1.2 For Manufacturing
Expansion Services which require dedicated equipment and/or facilities, the payment terms will include billing of the costs and
fees relating to such equipment and facilities to NW Bio. Likewise, for Manufacturing Expansion Services which require dedicated
personnel and/or systems or operations, the payment terms will include capacity charges as well as usage charges. The payment terms
for Manufacturing Expansion Services will cover a specified amount of such Services (e.g., for a specified site or facility), determined
by NW Bio. For Services in excess of the amounts NW Bio has contracted for, the payment terms will require payment at substantial
premium levels to cover the excess costs and difficulties of Cognate providing Services in excess of the amounts that NW Bio has
chosen and contracted for, and that have been budgeted and planned for.


 


2.1.3 If Cognate
sub-contracts, retains or otherwise arranges for third party experts or others to perform certain Manufacturing Expansion Services,
Cognate will undertake technology transfer to such third parties as needed, and will supervise and oversee performance of such
Services by such third parties as needed (collectively, the “Supervisory Services”), [*]. NW Bio will pay Cognate fees
for the Supervisory Services, and the amounts of such Supervisory Fees will be included in the applicable sub-agreement or work
order that is attached hereto as an exhibit and covers such Services. 


 


 


 





[*] Confidential treatment requested; certain information omitted
and filed separately with the SEC. 




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2.2    Milestone
and Initiation Payment 


 


Upon execution of
this Agreement, NW Bio will make an aggregate upfront payment (the “Milestone and Initiation Payment”) to Cognate
covering extensive preparatory work and an initiation payment relating to the initiation of substantial Manufacturing
Expansion Services on an urgent basis under this Agreement. NW Bio acknowledges and agrees that Cognate’s performance
of Manufacturing Expansion Services to date, including on an accelerated timetable, before even having an agreement in place,
have been of great value to NW Bio. NW Bio now needs a further expanded scope and amount of Manufacturing Expansion Services.
NW Bio will make Milestone and Initiation payments in connection with the launch of greatly expanded Manufacturing Expansion
Services pursuant to this Agreement, and in connection with milestones reached hereunder. The initial Milestone and
Initiation Payment will be made in the form of 1,071,287 shares of NW Bio Common Stock and Warrants exercisable for 511,142
shares of NW Bio Common Stock, with an exercise price of four dollars ($4.00) per share, an exercise period of five (5) years
from issuance, cashless exercise provisions and most favored nation provisions. NW Bio will also make milestone payments to
Cognate upon the achievement of mutually agreed operational milestones. Such milestones will be included in the ongoing
sub-agreements or work orders attached hereto as Exhibits, and/or may be otherwise agreed by the parties. The securities issued to Cognate hereunder will be subject to a lock-up for up to thirty (30) months from
issuance, or such longer period as the parties may mutually agree. NW Bio will compensate Cognate for such-lock up on market based
terms, and such terms will be subject to most favored nation provisions with respect to any securities issuances, agreements or
exercises involving any other investor or creditor. Under the lock-up, Cognate will be prohibited from selling or trading the covered
securities in the market.


 


2.3    Reimbursement
of Expenses


 


In addition to the
payments for the services and expenses provided in this Section 2, NW Bio will reimburse all expenses, including travel-related
costs, incurred by Cognate in performing any Services hereunder, and will pay an appropriate per diem amount.


 


2.4          Annual
Cost of Living Increases


 


All payment amounts
provided for pursuant to this Agreement will be subject to an annual increase of three percent (3%). The first increase will be
effective on the 12 month anniversary of the Effective Date this Agreement.


 


2.5          Form
and Timing of Payments


 


2.5.1 Payment
of Manufacturing Expansion Services Bills will be due within fifteen (15) after the invoice date. In the event that NW Bio fails
to pay any Manufacturing Expansion Services Bills within fifteen (15) days after the invoice date, then commencing thirty (30)
days after the invoice date and continuing until paid in full by cash and/or stock, the overdue amount will bear default interest
at the rate of one and one-half percent (1-1/2%) per month. If any collection action is undertaken to collect unpaid amounts, NW
Bio will pay all fees and costs associated with such collection actions including, without limitation, reasonable attorneys’
fees, as incurred.


 


2.5.2 At least
half of all Manufacturing Expansion Services Bills during the first eighteen (18) months following the Effective Date of this Agreement
(the “Conversion Period”) will be paid in shares of NW Bio Common Stock, with the remaining portions of such Manufacturing
Expansion Services Bills paid in cash. [*] The conversion price for any conversions after the Conversion Period will be jointly
determined by the parties, based upon market factors. With respect to any shares of NW Bio Common Stock to be issued hereunder,
Cognate may elect to receive unregistered shares immediately (with registration rights as provided herein) or to receive registered
shares on the earliest date that any registered shares are issued to any other investors after the invoice date of the Manufacturing
Expansion Services Bill being converted.


 


 





[*] Confidential treatment requested; certain information omitted
and filed separately with the SEC.









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2.6    Most
Favored Nation Terms


 


Notwithstanding anything
to the contrary herein, or in any other document or source, any amounts owed that are paid by NW Bio in shares, warrants and/or
other securities of any kind (including RSUs, convertible debt securities or other) issued or issuable in connection with this
Agreement (including any subsequent amendments hereof), will be subject to adjustment on a most favored nation basis relative to
the terms provided to any other investor or creditor of NW Bio during the Term of this Agreement or the Lock-Up Agreement, at Cognate’s
election, so that the terms of all shares, warrants and/or other securities issued or issuable under this Agreement will have terms
no less favorable to Cognate than the terms of any shares, warrants and/or other securities issued or issuable to any other investor
or creditor during the Term of this Agreement. For the avoidance of doubt, the application of most favored nation treatment will
include not only the price and terms of securities issued but also the addition of, and terms relating to, additional securities,
and additional rights and/or benefits to the investor or creditor (including warrants, rights of first refusal, registration rights,
pre-emptive rights, and/or other securities, rights or benefits). Such most favored nation adjustments may be implemented at any
time or times after being triggered by terms provided to other investors or creditors, and may be triggered on multiple occasions
with respect to a particular security issued hereunder.


 


2.7    [*]


 


[*]


 


SECTION 3:    CONFIDENTIALITY


 


In connection with this
Agreement, the parties will execute and maintain a mutual Confidential Disclosure Agreement substantially in the form attached
hereto as an exhibit.


 


SECTION 4:    REPRESENTATIONS
AND WARRANTIES 


 


4.1    Agreement
Duly Authorized; Valid and Binding Obligations


 


Cognate and NW Bio each
hereby represents and warrants, severally and not jointly, that:


 


4.1.1    Such
party is a corporation or entity duly organized, validly existing and in good standing under the laws of the jurisdiction where
such party is domiciled, and has all necessary power and authority to (i) own, operate and occupy its properties and to carry on
its business as presently conducted and (ii) enter into this Agreement and the other agreements, instruments and documents contemplated
hereby, and to consummate the transactions contemplated hereby and thereby. Such party is qualified to do business and is in good
standing in each jurisdiction in which the failure to so qualify would have a material adverse effect.


 


 





[*] Confidential treatment requested; certain information omitted
and filed separately with the SEC.









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4.1.2    All
necessary corporate or other proceedings, votes, resolutions, consents, waivers and approvals relating to the sale and purchase
of shares have been completed by the applicable party. Upon execution, this Agreement will constitute a valid and legally binding
obligation of the party, enforceable in accordance with its terms except (i) as limited by applicable bankruptcy, insolvency, reorganization,
moratorium, and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited
by laws relating to the availability of specific performance, injunctive relief or other equitable remedies.


 


4.2    Valid
Issuances; No Violation


 


NW Bio hereby represents
and warrants that:


 


Upon issuance hereunder,
each conversion share will be validly issued, fully paid and non-assessable. The execution, delivery, performance, issuance, sale
and delivery of this Agreement and compliance with the provisions hereof by NW Bio will not (a) violate any provision of NW Bio’s
certificate of incorporation or bylaws or, to the knowledge of NW Bio, any law, statute, rule or regulation applicable to NW Bio,
or any order, judgment or decree of any court, arbitrator, administrative agency or other governmental body applicable to NW Bio
or any of its assets or (b) conflict with or result in any material breach of any of the terms or conditions of any agreement or
instrument to which NW Bio is a party, or give rise to any right of termination, cancellation or acceleration under any such agreement
or instrument, or result in the creation of any lien or other encumbrance upon any of the material assets of NW Bio.


 


4.3    No
Warranties of Merchantability or Fitness


 


EXCEPT AS EXPRESSLY
SET FORTH IN THIS AGREEMENT, COGNATE MAKES NO WARRANTIES OR REPRESENTATIONS OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY, WITH RESPECT TO ANY MANUFACTURING EXPANSION SERVICES
RENDERED HEREUNDER, OR ANY TECHNOLOGY THAT MAY BE USED IN OR INCORPORATED INTO SUCH SERVICES, OR ANY EQUIPMENT OR FACILITIES DEVELOPED,
PROVIDED OR USED IN CONNECTION WITH SUCH SERVICES, OR ANY PRODUCTS PRODUCED HEREUNDER.


 


SECTION 5:    INSURANCE,
INDEMNIFICATION, LIABILITY


 


5.1    NW
Bio Insurance Obligations


 


NW Bio is required
to obtain and to maintain throughout the term of this Agreement, in such amounts as are reasonably acceptable to Cognate, (a) clinical
trial insurance covering all clinical trials of its DCVax® Products, (b) all-risks umbrella insurance, (c) product liability
insurance covering the distribution, use and administration of DCVax® Products to patients in expanded access, early access
and compassionate use programs as well as in commercialization, and (d) such other insurance as is reasonable or customary in the
industry. Cognate will be a named insured and beneficiary on all such insurance coverages.


 




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5.2    Cognate
Insurance Obligations


 


Cognate is required
to obtain and to maintain throughout the term of this Agreement, in such amounts as are reasonably acceptable to NW Bio, (a) product
liability insurance covering the manufacture of its DCVax® Products by Cognate, and (b) such other insurance as is reasonable
or customary in the industry. NW Bio will be a named insured and beneficiary on all such insurance coverages.


 


5.3    Indemnification



 


In addition to all
rights and remedies available to Cognate at law or in equity, NW Bio will indemnify and hold harmless Cognate and its successors,
assigns, affiliates and their respective present and former directors, officers, partners, employees, agents, representatives,
shareholders, successors and assigns (each an "Indemnified Party") to the fullest extent permitted by law from and against
all costs, expenses, losses, claims, damages, liabilities, [*] (the foregoing, collectively, “Damages”) (a) arising
from or pursuant to or relating to this Agreement and/or any transactions or services contemplated hereunder, including any treatment
of patients and any claims for refunds or Damages by or on behalf of patients and/or medical personnel; (b) arising from or relating
to any changes from the original agreement of the parties as described herein, or arising or relating to a delayed agreement, or
arising from or relating to delayed payment, delayed conversions and/or delayed issuances hereunder beyond the applicable Manufacturing
Services Bill dates or other applicable reference dates and/or the most favored nation price applicable to such Manufacturing Bill
conversions, or to the Milestone and Initiation Payments, and (c) arising from or relating to any use or administration to patients
of DCVax® Products manufactured by Cognate, provided that Cognate has manufactured such DCVax® Products substantially in
accordance with the applicable specifications or SOPs for such DCVax® Products and/or with commercially reasonable deviation
from such SOPs. NW Bio will pay all fees and expenses (including reasonable attorneys’ fees), as incurred, which are incurred
by or on behalf of an Indemnified Party, or to which an Indemnified Party may become subject, in connection with any matters covered
by this indemnification and/or in connection with investigating, preparing, pursuing, defending and resolving any threatened or
pending claim, action, proceeding or investigation (collectively, “Proceedings") arising therefrom, whether or not such
Indemnified Party is a formal party to such Proceedings.


 


SECTION 6:    TERM
AND TERMINATION


 


6.1    Term


 


This Agreement
will remain in force until the later of  until the later of seven (7) years from the Effective Date (the “Term”)
or five (5) years after the first commercial sales of DCVax®
Products pursuant to a Biologics License Application or marketing authorization (not a compassionate use, early
access, expanded access or similar authorization), unless terminated earlier pursuant to Section 6.2.


 




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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 non-breaching party will have all remedies for breach available at
law and in equity, including injunction or specific performance, regardless of whether such party elects to terminate this Agreement
or not.


 


SECTION 7:    REGISTRATION


 


7.1.    Unregistered
Shares.


 


For any conversion
shares issued hereunder which are unregistered under the Securities Act of 1933, as amended (the “Securities Act”)
at the time of issuance, the certificates evidencing such unregistered conversion shares may, if necessary, bear the following
legend (or a substantially similar legend) and such other legends as may be required by applicable laws:


 


“THESE
SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”). THEY MAY NOT BE SOLD,
OFFERED FOR SALE, PLEDGED OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT AS TO SUCH SECURITIES UNDER THE
ACT OR UNLESS SUCH TRANSACTION IS IN COMPLIANCE WITH APPLICABLE FEDERAL AND STATE SECURITIES LAWS.”


 


7.2    Registration.


 


Cognate will be entitled
to “piggyback” registration rights, with respect to all unregistered conversion shares issued hereunder and all other
shares and securities of NW Bio owned by Cognate and its affiliates, in any registrations effected by NW Bio until all such shares
and securities have been registered. NW Bio will use commercially reasonable efforts to complete such registrations by the earlier
of six (6) months after the Effective Date of this Agreement or six (6) months after issuance during the Term of this Agreement.


 


7.3    Registration
Costs.


 


NW Bio will bear all costs
and expenses (including attorneys’ fees) relating to the preparation and filing of all registrations which NW Bio is required
to undertake pursuant to this Agreement.


 




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SECTION 8:    MISCELLANEOUS


 


8.1    Governing
Law


 


This Agreement will be governed
by and construed in accordance with the laws of the State of Delaware, without regard to principles of conflicts of law.


 


8.2    Entire
Agreement 


 


This Agreement (including
all exhibits hereto, which are automatically incorporated herein by reference when added hereto during the Term of this Agreement
in accordance with this Agreement) constitutes the entire agreement of the parties with respect to the subject matter hereof, and
supersedes all prior agreements, understandings, promises or undertakings with respect to the subject matter hereof, provided however,
that this Agreement is part of a package of agreements which also includes a DCVax®-L Services Agreement, DCVax®-Direct
Services Agreement and Manufacturing Expansion Services Agreement.


 


8.3    Amendments


 


Except as otherwise expressly
provided herein, this Agreement may not be amended except by a written instrument signed by both parties hereto.


 


8.4    Survival


 


The provisions of Sections
2 – 5, and 7 hereof will survive the expiration or termination of this Agreement until expiration of the applicable statute
of limitations.


 


8.5    Notices


 


Any notices, consents,
waivers or other communications required or permitted to be given under the terms of this Agreement must be in writing and will
be deemed to be effective upon delivery when delivered (a) personally; (b) by facsimile or email, provided a copy is mailed no
later than the next business day through a nationally recognized overnight delivery service; or (c) by overnight delivery through
a nationally recognized overnight delivery service, in each case properly addressed to the receiving party at such address or facsimile
number as the receiving party has furnished to the sending party in writing.


 


8.6    Severability



 


If one or more provisions
of this Note are held to be unenforceable under applicable law, then (i) such provision will be excluded from this Note, (ii) the
balance of the Note will be interpreted as if such provision were so excluded, (iii) the balance of the Note will be enforceable
in accordance with its terms, and (iv) the parties will negotiate in good faith to amend or add to the provisions of this Note
to effectuate as nearly as reasonably practicable, and as nearly as permitted under applicable law, the original intent of the
parties with respect to the provision excluded.


 




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8.7    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.


 


8.8    Interpretations


 


All pronouns and any variations
thereof will be deemed to refer to the masculine, feminine, neuter, singular or plural, as the identity of the person or persons
or entity or entities may require. All references to “$” or dollars herein will be construed to refer to United States
dollars. The titles of the Sections and subsections of this Agreement are for convenience or reference only and are not to be considered
in construing this Agreement. All references to “including” will be deemed to mean “including, without limitation.”


 


8.9    Severability


 


If any provision of this
Agreement is determined to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions
will not in any way be affected or impaired thereby.


 


8.10    No
Waiver


 


No delay by a party hereto
in exercising or enforcing any rights hereunder will be deemed to be any waiver of such rights. No partial waiver of any right
or occurrence hereunder will be deemed to be any broader waiver, or waiver of any other right or occurrence, and no waiver on one
occasion shall be deemed to be a waiver on any other occasion.


 


8.11    Counterparts


 


This Agreement may be executed
in counterparts, each of which when so executed and delivered will constitute a complete and original instrument but all of which
together will constitute one and the same agreement, and it will not be necessary when making proof of this Agreement or any counterpart
thereof to account for any counterpart other than the counterpart of the party against whom enforcement is sought.


 


[signatures on following
page]


 




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IN WITNESS WHEREOF, the
parties have executed this Manufacturing Expansion Services Agreement effective as of the date first set forth above.


 


	NORTHWEST	 	COGNATE BIOSERVICES, INC.
	BIOTHERAPEUTICS, INC.	 	 
	 	 	 	 	 
	By:	 	 	By:	 
	 	 	 	 	 
	Name:	 	 	Name:	 


 




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