Exhibit 10.40

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

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”).

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 a 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, [*].

WHEREAS, both the quantity and the scope of services NW Bio has requested Cognate to provide greatly exceed the maximum amounts contemplated or provided for in the Prior Services Agreement, and the parties have jointly determined that the Prior Services Agreement needs to be amended accordingly, and certain services beyond the core manufacturing services need to be covered in separate agreements;

WHEREAS, Cognate has delivered, and will continue to deliver during the Term of this Agreement, its invoices to NW Bio on a current monthly basis for the services and facilities for NW Bio’s programs (collectively, the “ Manufacturing Bills ”);

[*]

WHEREAS, the parties desire to provide incentivized compensation in consideration of entering into series of amended and new Services Agreements to cover the increased amount of contract manufacturing and the wider range and increased amounts of related services by Cognate for the manufacture, distribution and handling of DCVax®-L Products for clinical trials and for subsequent commercialization; and

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

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

WHEREAS, the parties also desire to update their existing Quality Agreement associated with the manufacture of DCVax®-L and ensure that the new or amended Services Agreements meet the requirements set forth in such Quality Agreement.

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

Cognate will provide to NW Bio, on the terms and conditions set forth herein, Manufacturing Services as provided in Section 1.1. The Manufacturing Services may be referred to herein as the “Services.” Under separate agreements, Cognate will also provide Ancillary Services and Manufacturing Expansion Services as provided in Section 1.2.

1.1    Manufacturing Services

1.1.1    Scope of Manufacturing Services.

(A.) In the U.S., Cognate will provide Manufacturing Services for the production of DCVax®-L products for various cancers, including brain cancer (the “DCVax®-L Product(s)”). Such Manufacturing Services, together with related Ancillary Services, will comprise the services necessary for the production and release of the DCVax®-L Products for administration to human patients [*]. The Manufacturing Services do not include any services after product release at Cognate’s cGMP manufacturing facility and delivery by Cognate to the shipping company.

(B.) Outside the U.S., under the Prior Services Agreement Cognate has been providing extensive and ongoing technology transfer, technical support and general management and oversight of third party providers and manufacturers, and the services required by NW Bio have been growing and expanding substantially. Following the Effective Date of this Agreement, such services relating to third parties will be provided under the separate agreements for Ancillary Services. [*]

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

1.1.2    Manufacturing Services Capacity.     Cognate will commit to providing the necessary facilities and personnel for production of DCVax®-L Products for such number of Product Lots as is equal to the Maximum Product Lots for which NW Bio pays Facilities Capacity Payments and Product and Supplies Fees pursuant to Section 2 hereof. If NW Bio requests production of DCVax®-L Products in excess of the Maximum Product Lots, Cognate will use commercially reasonable efforts to accomplish such excess production as requested, provided that NW Bio pays for such services in accordance with Section 2 hereof.

1.1.3    Regulatory Standards. The Manufacturing Services will be carried out in accordance with current Good Manufacturing Practices (“cGMP”) requirements established by the U.S. Food and Drug Administration (“FDA”), or the equivalent requirements established by the applicable regulators outside the U.S.

1.2    Additional Agreements

Certain additional services relating to the DCVax-L program will be provided at NW Bio’s request under separate agreements. These include an Ancillary Services Agreement and a Manufacturing Expansion Services Agreement. The Ancillary Services will include shipping distribution and logistics services; cryopreservation and storage services; clinical support services; development and validation services; recordkeeping services, and others. The Manufacturing Expansion Services will include oversight, management and support of third party manufacturing outside the U.S., [*].

1.3    Quality Agreement

Under the prior Services Agreement, the parties had entered into a Quality Agreement establishing the quality standards to be met in DCVax®-L Products, the requirements for product release, the respective roles and responsibilities of NWBO and Cognate in these processes, the standards and procedures for the handling of any deviations from the usual quality standards or product release requirements, and/or any complaints, the processes and allocation of responsibilities for reporting of these matters, and related subjects. Within one hundred eighty (180) days after the Effective Date of this Agreement, the parties will update the existing Quality Agreement consistent with the terms of this Agreement. Such updated Quality Agreement will be attached hereto as Exhibit A and incorporated herein by reference.

SECTION 2:    PAYMENTS

2.1    Payments for Manufacturing Services in the U.S.

2.1.1    Facilities Capacity Payments.

For regular ongoing costs associated with facilities and equipment to be used in NW Bio programs, NW Bio will pay a monthly Facilities Capacity Payment. Such monthly payment does not include start-up costs, shut down costs, capital expenditures or other non-recurring costs (which are expected to be covered in the separate Manufacturing Expansion Services Agreement). The amount of the monthly Facilities Capacity Payment will be determined in relation to the capacity to provide for a specified number of Product Lots as follows, and will escalate with a consumer price index jointly selected by the parties:

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

[*]

2.1.2 Fixed Fees for Manufacturing Services and Supplies; Minimum Commitments.

(A.) For each Product Lot in the U.S. for which DCVax®-L Product is to be made, Cognate will undertake the Manufacturing Services as provided in Section 1. NW Bio will pay Cognate a fixed fee per Product Lot for the product costs as part of the Manufacturing Services relating to that Product Lot (the “Product Fee”). The Product Fee will initially be as follows, and will escalate with a consumer price index jointly selected by the parties.

[*]

(B.) In addition, NW Bio will pay a fixed fee per Product Lot for materials and consumables (including reagents and other) used in the Manufacturing Services for that Product Lot (the “Supplies Fee”). The amount of such Supplies Fee will be as follows, and will escalate with the consumer price index jointly selected by the parties.

[*]

(C.) The Manufacturing Services do not include any repetition of some or all of the manufacturing processes [*] except as expressly provided for and paid for, nor any additional processing beyond the standard processing, [*].

(D.) Cognate will hire, train and maintain sufficient technical staff for the manufacture of such volume of DCVax®-L products as specified in the Minimum Commitment below (or such higher volume as NW Bio may request and may be jointly agreed), and for ongoing regulatory compliance for such volume of DCVax®-L products.

(E.) Notwithstanding anything to the contrary, NW Bio hereby commits to a minimum volume of DCVax®-L Products (the “Minimum Commitment”) equal to [*].

(F.) [*]

2.1.3 Start-up, Change, Reduction and/or Shut-down Costs, Capital Expenditures:

For each program and/or facility that NW Bio desires to start up, expand, upgrade, change, reduce or shut down, Cognate will prepare budgets for the capital expenditures required. NW Bio will review and approve the applicable budgets for the capital expenditures involved in each such program or site start-up, expansion, upgrade, change, reduction or shut-down. NW Bio will pay the budgeted capital expenditures [*].

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

During the Term of this Agreement, if NWBO for any reason shuts down, suspends or incurs substantial delay in the DCVax®-L program in whole or in part, the following shutdown, suspension or delay fees shall apply to cover costs associated with such a shutdown or suspension. [*].

[*].

2.1.4 Expansion Planning and Implementation Costs:

Until the Manufacturing Expansion Services Agreement is executed between the parties, for each program and/or facility that NW Bio desires to expand, upgrade or change, Cognate will prepare budgets for the costs involved and the capital expenditures required. NW Bio will review and approve the applicable budgets for the costs and the capital expenditures involved in each such expansion. NW Bio will pay the budgeted costs and capital expenditures.

2.2 Payment for Manufacturing, and/or Supervisory Services Outside the U.S.

[*] Such services will be covered under a separate Agreement as needed, but in the absence of such a separate Agreement, the parties agree that such Services will be paid on market terms proportional in the applicable country market to the terms under to this Agreement, adjusted for the higher costs of such manufacturing services being performed [*].

2.3    Reimbursement of Travel Costs

In addition to the payments for various services and expenses provided in this Section 2, NW Bio will reimburse all travel-related costs incurred by Cognate in performing any services hereunder. Such reimbursements will include appropriate per diem travel cost payments, to be jointly agreed by the parties in connection with each set of services, and reimbursement of all travel-related costs not covered by agreed per diem payments.

2.4    [*]

[*]

2.5    Credit Terms and Collection Costs

If NW Bio does not make a payment or reimbursement when due, the outstanding unpaid amounts will accrue interest at a default interest 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.

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

2.6    Yearly Adjustment

All payment amounts referenced in this Agreement shall be subject to a yearly increase of three percent (3%). The first increase shall be effective on the first invoice after the 12 month anniversary of this Agreement.

2.7    Milestone and Initiation Payments

The disinterested members of the Board of Directors of NW Bio agree that the magnitude of the undertakings now being asked of Cognate, particularly in view of the extraordinary performance by Cognate to date, and the scale and scope of services needed, which far exceeds the parties’ expectations when the Prior Agreement was entered into, requires a substantial initiation payment in connection with the major expansion of the DCVax-L program needed by NW Bio (the “Initiation Payment”). The disinterested Members of the Board agree that the excess services and accelerated timelines are of great value to NW Bio. [*] NW Bio will also make milestone payments to Cognate upon the achievement of mutually agreed operational milestones, such as [*].

2.8    Other Payment Terms

2.8.1 Payment of Manufacturing Bills Pursuant to Work Performed Under the Terms of this Agreement: Payment of Manufacturing Bills will be due within fifteen (15) after the invoice date. In the event that NW Bio fails to pay any Manufacturing 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. At least half of all Manufacturing 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 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 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 date of the Manufacturing Bill being converted [*].

2.8.2 Most Favored Nation Conversion 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 (such as restricted stock units, 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 or applied to any other investor or creditor of NW Bio during the Term of this Agreement or the Lock-Up Agreement, so that the terms of all shares, warrants and 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 or the Lock-Up 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, 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 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.

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

SECTION 3:    CONFIDENTIALITY

In connection with this Agreement, the parties will maintain a mutual Confidentiality Agreement.

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:

4.2.1    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.

4.2    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 the NW Bio, any law, statute, rule or regulation applicable to or NW Bio 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 material breach of any of the terms or conditions of any agreement or instrument to which NW Bio is a party, or given 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 DCVAX®-L PRODUCTS OR ANY SERVICES RENDERED HEREUNDER, OR ANY TECHNOLOGY THAT MAY BE USED IN SUCH SERVICES OR INCORPORATED INTO SUCH DCVAX®-L PRODUCTS.

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 DCVax®-L Products, (b) all-risks umbrella insurance, (c) product liability insurance covering the distribution, use and administration of DCVax®-L Products to patients, and (d) such other insurance as is reasonable or customary in the industry. Cognate shall be a named insured and beneficiary on all such insurance coverages.

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 DCVax®-L Products by Cognate, and (b) such other insurance as is reasonable or customary in the industry. NW Bio shall 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, [*] (a) arising from or relating to this Agreement and/or any transactions or services contemplated hereunder, (b) arising from or relating to any changes from the original agreement of the parties as described herein, or arising from 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 Bill dates or other applicable reference dates, and (c) arising from or relating to any use or administration to patients of DCVax®-L Products manufactured by Cognate, provided that Cognate has manufactured such DCVax® Products substantially in accordance with the applicable specifications or SOPs for such DCVax®-L 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.

5.4    No Consequential Damages

Notwithstanding anything to the contrary, in no event shall either party shall be liable hereunder, on any basis, for any indirect or consequential damages.

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.

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 registration of such unregistered conversion shares 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. 

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 the Exhibits hereto), 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, including the prior Services Agreement, provided however, that the provision in the Prior Services Agreement (and the agreement prior to that) for a penalty payment of $2 million from NW Bio to Cognate, to which Cognate was entitled in connection with failure by NW Bio to complete enrollment in NW Bio’s Glioblastoma multiforme clinical trial by a specified date, survives and remains applicable, and has not been and is not waived, and provided further that this Agreement is part of a package of agreements which also a DCVax®-Direct Services Agreement and multiple Ancillary Services agreements (including a Distribution, Software and Specialty Services Agreement, a Manufacturing Expansion and Support Agreement and related agreements).

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    Adjustments for Stock Splits and Similar Transactions

In the event of a stock split, reverse split or other similar transaction during the Term of this Agreement, the prices and other numbers herein will be adjusted accordingly.

8.5    Survival

The provisions of Sections 2 - 5 herein will survive the expiration or termination of this Agreement until expiration of the applicable statute of limitations.

8.6    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.

8.7    Severability

If one or more provisions of this Agreement are held to be unenforceable under applicable law, then such provision shall be excluded from this Agreement, the balance of the Agreement shall be enforceable in accordance with its terms, and the parties shall negotiate in good faith to amend or add to the provisions of this Agreement 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.

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.

8.9    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” shall be deemed to mean “including, without limitation.”

8.10    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 the following page]

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

Exhibit 10.41

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

DCVAX-DIRECT MANUFACTURING AND 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 a 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 Cognate to provide greatly exceed the maximum amounts contemplated or provided for in the Prior Services Agreement, and the parties have jointly determined that the Prior Services Agreement needs to be amended accordingly, and certain services beyond the core manufacturing services need to be covered in separate agreements;

WHEREAS, Cognate has delivered, and will continue to deliver during the Term of this Agreement, its invoices to NW Bio on a current monthly basis for the services and facilities for NW Bio’s programs (collectively, the “ Manufacturing Bills ”);

[*]

WHEREAS, Cognate has also undertaken and completed on a highly accelerated basis [*] NW Bio’s DCVax®-Direct product and the manufacturing thereof, [*];

WHEREAS, building upon the initial stages of work already completed, the parties desire to carry out the [*]work required, including research and development, manufacture, distribution and handling of DCVax®-Direct Products for clinical trials and for subsequent commercialization. [*];

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

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

WHEREAS, the parties also desire to update their existing Quality Agreement associated with the manufacture of DCVax®-Direct and ensure that the new or amended Services Agreements meet the requirements set forth in such Quality Agreement.

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

Cognate will provide to NW Bio, on the terms and conditions set forth herein, Manufacturing Services as provided in Section 1.1. The Manufacturing Services may be referred to herein as the “Services.” Under separate agreements, Cognate will also provide Ancillary Services and Manufacturing Expansion Services as provided in Section 1.2.

1.1    Manufacturing Services

1.1.1 Scope of Manufacturing Services.

(A.) In the U.S., Cognate will provide Manufacturing Services for the production of DCVax®-Direct products for various solid tumor cancers, (the “DCVax®-Direct Product(s)”). Such Manufacturing Services, together with related Ancillary Services, will comprise the services necessary for the production and release of the DCVax®-Direct Products for administration to human patients (including, without limitation, materials management, quarantined inventory, quality control, quality assurance, sterility testing, potency assays and lot release). The Manufacturing Services do not include any services after product release at Cognate’s cGMP manufacturing facility and delivery by Cognate to the shipping company.

(B.) Outside the U.S., under the Prior Services Agreement Cognate has been providing extensive and ongoing technology transfer, technical support and general management and oversight of third party providers and manufacturers, and the services required by NW Bio have been growing and expanding substantially. Following the Effective Date of this Agreement, such services relating to third parties will be provided under the separate agreements for Ancillary Services. [*]. The amounts to be billed by Cognate for such direct Manufacturing Services outside the U.S. will be jointly agreed by the parties based upon market factors and costs, and are anticipated to be substantially higher than in the U.S., particularly with respect to direct and indirect personnel costs. This Agreement will include (and will be further amended and restated as needed to include) direct Manufacturing Services outside the U.S. as soon as Cognate is ready to begin preparations for and implementation of such Services.

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

1.1.2    Manufacturing Services Capacity.         Cognate will commit to providing the necessary facilities and personnel for production of DCVax®-Direct Products [*]. If NW Bio requests production of DCVax®-Direct Products in excess of the Maximum Product Lots, Cognate will use commercially reasonable efforts to accomplish such excess production as requested, provided that NW Bio pays for such services in accordance with Section 2 hereof.

1.1.3    Regulatory Standards. The Manufacturing Services will be carried out in accordance with current Good Manufacturing Practices (“cGMP”) requirements established by the U.S. Food and Drug Administration (“FDA”), or the equivalent requirements established by the applicable regulators outside the U.S.

1.2    Additional Agreements

Certain additional services relating to the DCVax-L program will be provided at NW BIO’s request under separate agreements. These include an Ancillary Services Agreement and a Manufacturing Expansion Services Agreement. The Ancillary Services will include shipping distribution and logistics services; cryopreservation and storage services; clinical support services; development and validation services; recordkeeping services, and others. The Manufacturing Expansion Services will include oversight, management and support of third party manufacturing outside the U.S., [*] and supporting new and/or upgraded or expanded manufacturing capacity for NW BIO’s programs.

1.3    Quality Agreement

Under the prior Services Agreement, the parties had entered into a Quality Agreement establishing the quality standards to be met in DCVax®-Direct Products, the requirements for product release, the respective roles and responsibilities of NW Bio and Cognate in these processes, the standards and procedures for the handling of any deviations from the usual quality standards or product release requirements, and/or any complaints, the processes and allocation of responsibilities for reporting of these matters, and related subjects. Within one hundred eighty (180) days after the Effective Date of this Agreement, the parties will update the existing Quality Agreement consistent with the terms of this Agreement. Such updated Quality Agreement will be attached hereto as Exhibit A and incorporated herein by reference.

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

SECTION 2:    PAYMENTS

2.1     Payments for Manufacturing Services in the U.S.

2.1.1     Facilities Capacity Payments.

For regular ongoing costs associated with facilities and equipment to be used in NW Bio programs, NW Bio will pay a monthly Facilities Capacity Payment. Such monthly payment does not include start-up costs, shut down costs, capital expenditures or other non-recurring costs (which are expected to be covered in the separate Manufacturing Expansion Services Agreement). The amount of the monthly Facilities Capacity Payment will be determined in relation to the capacity to provide for a specified number of Product Lots as follows, and will escalate with a consumer price index jointly selected by the parties:

·     [*]

·     [*]

2.1.2 Fixed Fees for Manufacturing Services and Supplies; Minimum Commitments.

(A.) [*]

(B.) [*]

     [*]

     [*]

(C.) [*]

(D.) Cognate will hire, train and maintain sufficient technical staff for the manufacture of such volume of DCVax®-Direct products as specified in the Minimum Commitment below (or such higher volume as NW Bio may request and may be jointly agreed), and for ongoing regulatory compliance for such volume of DCVax®-Direct products.

(E.) Notwithstanding anything to the contrary, NW Bio hereby commits to a minimum volume of DCVax®-Direct Products (the “Minimum Commitment”) equal to [*]

(F.) [*]

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

2.1.3 Start-up, Change, Reduction and/or Shut-down Costs, Capital Expenditures:

For each program and/or facility that NW Bio desires to start up, expand, upgrade, change, reduce or shut down, Cognate will prepare budgets for the capital expenditures required. NW Bio will review and approve the applicable budgets for the capital expenditures involved in each such program or site start-up, expansion, upgrade, change, reduction or shut-down. NW Bio will pay the budgeted capital expenditures. If NW Bio decides for any reason to shut-down or suspend the DCVax®-Direct program in whole or in part, the following shutdown or suspension fees shall apply to cover costs associated with such a shutdown or suspension. These fees are separate from and additional to any other payments under this Agreement, including any remedies in connection with any breach of this Agreement whether such breach is associated with such shut down, suspension or substantial delay or otherwise.

[*]

[*]

[*]

[*]

2.1.4 Expansion Planning and Implementation Costs:

Until the Manufacturing Expansion Services Agreement is executed between the parties, for each program and/or facility that NW Bio desires to expand, upgrade, or change, Cognate will prepare budgets for the costs involved and the capital expenditures required. NW Bio will review and approve the applicable budgets for the costs and the capital expenditures involved in each such expansion. NW Bio will pay the budgeted costs and capital expenditures.

2.2 Payment for Manufacturing, and/or Supervisory Services Outside the U.S.

[*]. Such services will be covered under a separate Agreement, as needed, but in the absence of such a separate Agreement, the parties agree that such Services will be paid on market terms proportional in the applicable country market to the terms under to this Agreement, adjusted for the higher costs of such manufacturing services being performed [*].

2.3    Reimbursement of Travel Costs

In addition to the payments for various services and expenses provided in this Section 2, NW Bio will reimburse all travel-related costs incurred by Cognate in performing any services hereunder. Such reimbursements will include appropriate per diem travel cost payments, to be jointly agreed by the parties in connection with each set of services, and reimbursement of all travel-related costs not covered by agreed per diem payments.

2.4    [*]

[*]

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

2.5    Credit Terms and Collection Costs

If NW Bio does not make a payment or reimbursement when due, the outstanding unpaid amounts will accrue interest at a default interest 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.

2.6    Yearly Adjustment

All payment amounts referenced in this Agreement shall be subject to a yearly increase of three percent (3%). The first increase shall be effective on the first invoice after the 12 month anniversary of this Agreement.

2.7    Milestone and Initiation Payments

The disinterested members of the Board of Directors of NW Bio agree that the magnitude of the undertakings now being asked of Cognate, particularly in view of the extraordinary performance by Cognate to date, and the scale and scope of services needed, which far exceeds the parties’ expectations when the Prior Agreement was entered into, [*]. NW Bio will also make milestone payments to Cognate upon the achievement of mutually agreed operational milestones, [*].

2.8    Other Payment Terms

2.8.1 Payment of Manufacturing Bills Pursuant to Work Performed Under the Terms of this Agreement: Payment of Manufacturing Bills will be due within fifteen (15) after the invoice date. In the event that NW Bio fails to pay any Manufacturing 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. At least half of all Manufacturing 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 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 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 date of the Manufacturing Bill being converted. [*].

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

2.8.2 Most Favored Nation Conversion 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 (such as restricted stock units, convertible debt securities or other) issued or issuable under 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 or applied to any other investor or creditor of NW Bio during the Term of this Agreement or the Lock-Up Agreement, so that the terms of all shares, warrants and 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 or the Lock-Up 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.

SECTION 3:     CONFIDENTIALITY

In connection with this Agreement, the parties will maintain a mutual Confidentiality Agreement.

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:

4.2.1    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.

4.2    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 the NW Bio, any law, statute, rule or regulation applicable to or NW Bio 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 DCVAX®-DIRECT PRODUCTS OR ANY SERVICES RENDERED HEREUNDER, OR ANY TECHNOLOGY THAT MAY BE USED IN SUCH SERVICES OR INCORPORATED INTO SUCH DCVAX®-DIRECT PRODUCTS.

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 DCVax®-Direct Products, (b) all-risks umbrella insurance, (c) product liability insurance covering the distribution, use and administration of DCVax®-Direct Products to patients, and (d) such other insurance as is reasonable or customary in the industry. Cognate shall be a named insured and beneficiary on all such insurance coverages.

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 DCVax®-Direct Products by Cognate, and (b) such other insurance as is reasonable or customary in the industry. NW Bio shall 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, [*]) (a) arising from or relating to this Agreement and/or any transactions or services contemplated hereunder, (b) arising from or relating to any changes from the original agreement of the parties as described herein, or arising from or relating to a delayed agreement, or arising from or relating to from delayed payment, delayed conversions and/or delayed issuances hereunder beyond the applicable Manufacturing Bill dates or other applicable reference dates, and (c) arising from or relating to any use or administration to patients of DCVax®-Direct Products manufactured by Cognate, provided that Cognate has manufactured such DCVax® Products substantially in accordance with the applicable specifications or SOPs for such DCVax®-Direct 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.

5.4 No Consequential Damages

Notwithstanding anything to the contrary, in no event shall either party shall be liable hereunder, on any basis, for any indirect or consequential damages.

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 ®-Direct 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 requested; certain information omitted and filed separately with the SEC.

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 registration of such unregistered conversion shares 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. 

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 constitutes the entire agreement of the parties with respect to the subject matter hereof, and supersedes all prior agreements for DCVax®-Direct, 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 and multiple Ancillary Services agreements (including a Clinical Support, Shipping, Distribution and Logistics, and Scheduling Specialty Services Agreement, a Manufacturing Expansion and Support Agreement and related agreements).

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    Adjustments for Stock Splits and Similar Transactions

In the event of a stock split, reverse split or other similar transaction during the Term of this Agreement, the prices and other numbers herein will be adjusted accordingly.

8.5    Survival

The provisions of Sections 2 - 5 herein will survive the expiration or termination of this Agreement until expiration of the applicable statute of limitations.    

8.6    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.

8.7    Severability

If one or more provisions of this Agreement are held to be unenforceable under applicable law, then such provision shall be excluded from this Agreement, the balance of the Agreement shall be enforceable in accordance with its terms, and the parties shall negotiate in good faith to amend or add to the provisions of this Agreement 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.

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.    

8.9    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” shall be deemed to mean “including, without limitation.”

8.10    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 the following page]

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

Exhibit 10.42

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

ANCILLARY SERVICES AGREEMENT

This Ancillary 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”), effective April 1, 2011, and a Conversion and Lock-Up Agreement (the “Lock-Up Agreement”);

WHEREAS, Cognate has dedicated cGMP facilities and other facilities to NW Bio programs,[*];

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, at NW Bio’s request, certain services [*] were undertaken by Cognate on a highly expedited basis in order to meet certain NW Bio timelines prior to this Agreement;

WHEREAS, Cognate has successfully accomplished all milestones planned by the parties or requested by NW Bio, and NW Bio wishes to recognize such accomplishments and incentivize Cognate to achieve further milestones by awarding milestone based bonuses during the Term of this Agreement;

WHEREAS, NW Bio is continuing to substantially expand its clinical programs both in the US and abroad, NW Bio also anticipates undertaking and/or expanding compassionate use and/or other early access or expanded access programs [*], and NW Bio needs corresponding ongoing expansion of the quantity and scope of services provided by Cognate for these programs.

WHEREAS, NW Bio’s DCVax Products may potentially be applicable to tens or hundreds of thousands of patients or more. [*];

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

WHEREAS, the parties desire to enter into a specialty services agreement, in the form of this Ancillary Services Agreement, for the clinical and commercial support services, including cryopreservation, shipping, manufacturing and quality control/quality assurance validation, product distribution, logistics and scheduling of the DCVax® Products for clinical trials and for subsequent commercialization as defined herein;

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

[*].

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 acknowledged, the parties hereby agree as follows:

SECTION 1:    SERVICES

1.1    General

1.1.1 NW Bio will obtain from Cognate, and Cognate will provide to NW Bio, on the terms and conditions set forth herein, Cryopreservation and Storage Services as provided in Section 1.2, Clinical and Commercial Support Services as provided in Section 1.3; Supplier Sourcing, Validation and Monitoring as provided in Section 1.4; Shipping, Distribution and Logistics Services as provided in Section 1.5; Scheduling System and Other Software Design, Development and Services as provided in Section 1.6; Recordkeeping as provided in Section 1.7; Product and Process Validation Services, as provided in Section 1.8; and such other services as may be necessary, as provided in Section 1.9, in connection with the clinical site interactions and the development, manufacturing, storage, tracking, shipping, logistics, distribution and follow-up of DCVax® Products for clinical trials, early access and expanded access programs (including compassionate use programs), and commercialization (collectively, the “DCVax Products”). All of the foregoing services, collectively, comprise the “Ancillary Services” or the “Services.”

1.1.2 During the Term of this Agreement, on an ongoing basis, the parties will jointly determine the Ancillary Services required for NW Bio’s programs, and will enter into sub-agreements or work orders for such Services which will be attached hereto as Exhibits and incorporated herein by reference. Where applicable, Cognate may sub-contract with or retain one or more experts or third parties to assist in the provision of Ancillary Services and will include such experts and third parties in the applicable sub-agreements or work orders, [*]

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

1.1.3 The parties acknowledge and agree that the clinical site interactions and the development, manufacturing, storage, tracking, shipping, logistics, distribution and follow-up of DCVax® Products [*]

1.2    Cryopreservation and Storage Services

1.2.1 Cognate will provide (a) cryopreservation and storage of the DCVax® Products and related reagents and materials, including both short-term and long-term storage of DCVax® Products and of materials related to or to be used in the DCVax® Products; (b) evaluation and testing, design, procurement, development, installation, operation and maintenance of necessary cryopreservation equipment and facilities (especially for dedicated storage); (c) procurement and maintenance of the materials and reagents used in the production and processing of the DCVax® Products [*]; (d) processing and preparation of the DCVax® Products for freezing; (e) freezing and frozen maintenance of the DCVax® Products; (f) [*] and (g) preparation of the DCVax® Products for shipment and tracking as provided below (the foregoing, collectively, “Cryopreservation and Storage Services”). Such Cryopreservation and Storage Services will include materials and reagents used in the manufacture of DCVax® Products, as well as patient-specific biomaterials (including immune cells, tumor tissue and other) [*].

1.2.2 Cognate will perform capacity assessments to determine the cryopreservation and storage equipment and facilities needed for specified numbers of patients for the DCVax® Products, will advise NW Bio of the equipment and facilities required, and will develop and implement designs and plans for such equipment and facilities, and the procurement, development, installation and set-up, calibration, validation and certification thereof, both initially and on an ongoing basis.

1.2.3 [*]

1.3    Clinical and Commercialization Support Services

1.3.1 Cognate will assist NW Bio in training clinical trial sites about the DCVax technology and products [*] Cognate will help provide communication and coordination support between and among NW Bio, the trial sites, the contract research organization managing the applicable trial (particularly in regard to the management and allocation of manufacturing capacity, and the timing and delivery of products to the sites, and reagents needed to transport patient’s tissues to Cognate, as needed). Cognate will provide similar assistance for NW Bio and the sites for commercialization of the DCVax® Products.

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

1.3.2 Cognate will assist NW Bio in training new clinical sites on the requirements of the clinical protocol during site initiation visits in NW Bio’s clinical programs. Cognate will provide similar training services for the initiation of commercial sites following approvals of the DCVax® Products. [*]

1.3.3 [*]

1.3.4 [*]

1.4    Supplier Sourcing, Validation and Monitoring

1.4.1     Requirements. All supplies and ingredients used in the production, cryopreservation and use of DCVax® Products [*] must be procured from suppliers who are in compliance with applicable [*] regulatory requirements, and acceptable to the regulatory authorities in the applicable countries. [*]

1.4.2     Cognate Services.    Cognate will identify potentially suitable suppliers and will conduct such initial and ongoing supplier evaluations, inspections, validation and monitoring in accordance with applicable regulatory requirements. Cognate will also identify potentially suitable supplies and ingredients for DCVax® Products, and conduct the initial and ongoing testing of each lot or batch of such supplies and ingredients, in accordance with applicable regulatory requirements. [*]

1.5    Shipping, Distribution and Logistics Services

1.5.1 Cognate will coordinate and manage or oversee (a) the preparation of the tumor collection kits, leukapheresis collection kits and other materials as well as the finished DCVax® Products for shipment to the clinical and commercial sites, (b) the scheduling, pick-up and other aspects of arrangements with the shipping companies for shipments to the sites and back from the clinical and commercial sites to the manufacturing facilities, (c) the tracking of shipments and deliveries, and (d) such other services as may be necessary for the outgoing shipment and distribution of all kits and other materials to the sites, the incoming shipments of kits from the sites to the manufacturing facilities, and the outgoing shipments of finished DCVax® Products to the sites. Notwithstanding the foregoing, Cognate will not be responsible in any way on any basis, either directly or indirectly, for the handling or condition of any DCVax® Products after such DCVax® Products leave the manufacturing facility [*]

1.5.2 Cognate will procure the necessary materials and assemble and/or produce the kits needed for tumor tissue collection and for leukapheresis collection for the DCVax® Products.

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

1.5.3 (a) Specialized “dry shipper” shipping containers, filled with liquid nitrogen (LN2), are required for the shipment of frozen DCVax® Products in order to maintain sufficiently cold temperatures [*]

(b) [*]

(c) [*]

(d) [*]

1.6    Scheduling and Software Services

1.6.1 Extensive scheduling is required for each patient who is to be treated with DCVax® Products, and the scheduling process includes but is not limited to:

·     [*]

·     [*]

·     [*]

·     [*]

·     [*]

This scheduling requires extensive interaction between and among the clinical sites, Cognate and NW Bio. The sites must be able to coordinate their scheduling of patient procedures (tumor removal, leukapheresis and DCVax treatments) with the availability of production capacity at the manufacturing facilities. The number of tumor tissues and/or leukapheresis kits that arrive at the manufacturing facilities on a given day must be tightly controlled. [*]

When the DCVax® Products reach commercialization, the extensive scheduling on the foregoing (operational) bases will also have to be coordinated with billing and payments.

1.6.2 [*]

1.6.3 [*]

1.7    Documentation and Recordkeeping

1.7.1 Regulatory compliance requires numerous documents and extensive recordkeeping. [*] Such records must cover all aspects of the production process, the product ingredients and their sourcing and testing, quality control, quality assurance and product release, and the finished DCVax® Products themselves. In addition, recordkeeping must include information about any serious adverse events related or possibly related to the DCVax® Products. The parties acknowledge and agree that special arrangements are necessary for fulfillment of such comprehensive and long-term recordkeeping obligations. NW Bio will obtain legal and regulatory advice, and determine the scope and extent of recordkeeping required for each country, and so advise Cognate. Cognate will analyze the systems, capacity and other requirements necessary to fulfill the recordkeeping specified by NW Bio, and determine whether other parties may be needed to provide such services. Both NW Bio and Cognate will have full access to all such records and information at all times, whether or not the records are being stored and managed by third parties, or third parties are otherwise involved in the long-term recordkeeping and related regulatory compliance.

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

1.7.2 In conjunction with production of DCVax® Products, Cognate will create initial sets of applicable records. Such records will include batch production records and other records required for initial regulatory compliance at the time of production and product release. Both NW Bio and Cognate will have full access to all such records and information at all times, whether or not the records are being stored and managed by third parties, or third parties are otherwise involved in this recordkeeping and related regulatory compliance.

1.8    Product and Process Validation Services

1.8.1 [*]

1.8.2 [*]

1.9    Quality Agreement

A Quality Agreement between the parties is required in order to comply with regulatory requirements. The Quality Agreement establishes and specifies the quality standards to be met in the DCVax® Products, the requirements for product release, the respective roles and responsibilities of NW Bio and Cognate in these processes, the standards and procedures for the handling of any deviations from the usual quality standards or product release requirements, and/or any complaints, the processes and allocation of responsibilities for reporting of these matters, and related subjects. The parties have previously entered into a Quality Agreement, but will need to enter into one or more updated Quality Agreements during the term of this Agreement. As promptly as practicable after the Effective Date of this Agreement, the parties will execute an updated or new Quality Agreement consistent with the terms of this Agreement, and such Quality Agreement will be attached as an exhibit hereto.

1.10    Other Services

In addition to the services provided for under the foregoing Sections 1.1 through 1.9, the parties will determine any other services which may be required for the clinical site interactions and the development, manufacturing, storage, tracking, shipping, logistics, distribution and follow-up of DCVax® Products, and the parties will develop work plans, timelines and budgets for execution of such other services by Cognate pursuant to this Agreement.

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

SECTION 2:    PAYMENTS

2.1    Payment Terms for Ancillary Services

2.1.1 The parties will determine and agree upon the payment terms for the Ancillary 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 Ancillary 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 Ancillary Services which require dedicated personnel and/or clean rooms, cold storage, quarantined storage, and/or other dedicated spaces and/or timeslots, the payment terms will include capacity charges as well as usage charges. The payment terms for Ancillary Services will cover a specified amount of such Services [*] chosen by NW Bio. For Services in excess of the amounts NW Bio has chosen and 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 Ancillary 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 .

2.2    Milestone and Initiation Payments

Upon execution of this Agreement, [*]. NW Bio acknowledges and agrees that Cognate’s performance of Ancillary 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 greatly expanded scope and amount of such Ancillary Services. [*]. NW Bio will also make milestone payments to Cognate upon the achievement of mutually agreed operational milestones. Such milestones may be included in the ongoing sub-agreements or work orders attached hereto as Exhibits, or may be otherwise agreed by the parties. [*]

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

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 Ancillary Services Bills will be due within fifteen (15) after the invoice date. In the event that NW Bio fails to pay any Ancillary 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 Ancillary 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 Ancillary 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 Ancillary Services Bill (or Milestone and Initiation Payments) being converted.

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

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, 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 or the Lock-Up 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.

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.

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

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 ANCILLARY 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.

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 from or relating to a delayed agreement, or arising from or relating to delayed payment, delayed conversions and/or delayed issuances hereunder beyond the applicable Ancillary Services Bill dates or other applicable reference dates and/or the most favored nation price applicable to such Ancillary 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 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.

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.

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

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. 

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 7-8 hereof will survive the expiration or termination of this Agreement until expiration of the applicable statutes 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.

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]

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

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.

[*]

[*]

[*]

[*]

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. 

2.2    Milestone and Initiation Payment

[*] 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. [*] 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. [*]

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.

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