Work Order #1 between Marker Therapeutics, Inc. and Cell Ready LLC dated February 22, 2024
Exhibit 10.9
Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
WORK ORDER #1
GMP-Q1-2024
Marker GMP manufacturing
Proposal on February 22nd, 2024
Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
TABLE OF CONTENTS
Section 1: Recitals | 3 |
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Section 2: Executive Summary | 6 |
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Section 3: Proposed Statement of Work | 7 |
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Section 4: Estimated Project Timelines | 8 |
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Section 5: Pricing and Deliverables | 9 |
Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
THIS WORK ORDER #1 (the "Work Order") is effective and entered into as of this 22' day of February, 2024 (the "Effective Date") by and between Marker Therapeutics, Inc., a Delaware corporation with offices at 9350 Kirby Drive, Suite 300, Houston, TX 77054, USA (hereinafter referred to as "Marker" or "Client") and Cell Ready, LLC., a Minnesota corporation having a principal place of business at 2100 Old Highway 8 NW St. Paul, MN 55112 (hereinafter referred to as "Supplier" or "CellReady"). Marker and Supplier may be referred to individually, as a "Party" and collectively, as the "Parties".
SECTION 1: RECITALS
RECITALS
WHEREAS, Marker and Supplier entered into a Master Services Agreement for Product Supply dated February 22", 2024 (the "Master Services Agreement"), which allows Marker to request agreed upon services from Supplier.
WHEREAS, in accordance with the Master Services Agreement, this Work Order sets out the Services to be provided by Supplier to Marker.
NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which is acknowledged, the Parties hereto agree to the following:
1.INTERPRETATION
1.1This Work Order incorporates the terms of the referenced Master Services Agreement. All defined terms in the Master Services Agreement shall have the same meaning in this Work Order unless otherwise stated.
2.TERM AND TERMINATION
2.1This Work Order shall commence on the Effective Date as specified above and shall expire upon the completion of the delivery of the Services unless terminated earlier in accordance with the Master Services Agreement.
3.SERVICES AND SERVICE CHARGES
3.1Supplier shall provide the Services and Deliverables as set out in Section 3 of this Work Order to Marker.
3.2Total projected sum (taxes included) for services specified in this Work Order is not anticipated to exceed [****]. The Final cost of materials and applicable taxes may vary from lot to lot, as outlined in Section 5 of this Work Order.
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
4.PAYMENT TERMS
4.1All invoices for payment under this Work Order shall be submitted to:
Marker Therapeutics, Inc.
Address: 9350 Kirby Drive I Suite 300 I Houston, TX 77054 I USA
[****]
Supplier invoices under this Work Order shall be made payable to:
Bank Account no: [****]
Name and Address of Bank: [****]
US Routing no: [****]
Swift Code: N/A
Name and Address of a/c Holder: [****]
S.ADDITIONAL TERMS AND CONDITIONS
5.1Any terms and conditions in addition to those specified above and in the Master Services Agreement are set out in the Quality Agreement and IT service agreement.
[Signature Page Follows]
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Work Order as of the Effective Date.
Marker Therapeutics, Inc. |
| Cell Ready LLC | ||
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By: | /s/Juan Vera | | By: | /s/John Wilson |
Name: | Juan Vera | | Name: | John Wilson |
Title: | Chief Executive Officer | | Title: | Chief Executive Officer |
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
SECTION 2: EXECUTIVE SUMMARY
Marker Therapeutics, (Client) is currently developing a Multi-TAA cell therapy for cancer treatment and has requested that CellReady provide a proposal for GMP manufacturing of drug products suitable for use
in Phase I/IIclinical trials.
CellReady Overview. CellReady is a Contract Development and Manufacturing Organization (CDMO). It is on a mission to greatly simplify CGT manufacturing and save years of time and millions of dollars for every client. CellReady is wholly owned by John Wilson, a co-inventor G-Rex® technology which is widely used to create Cell and Gene Modified Cell Therapy (CGT) drug products including commercially approved therapies. With vast expertise in G-Rex® centric manufacturing processes, deep experience in the business of taking CGT drugs to market, a robust network of subject matter experts, and a business philosophy grounded in the law of abundance, CellReady is the go-to place for every CGT company.
Proposed Scope of Work. Based on CellReady's experience in developing scalable manufacturing processes for cell therapy products and the Marker's stated needs, CellReady is proposing the following manufacturing program:
[****]([****]x) GMP manufacturing runs of Marker MT-401 and/or MT-601: Cost is based on use of fresh or frozen donor starting material, one (1) G-Rex500M-TF per run, QC testing, and QA release for each of the [****] ([****]) runs. QC testing includes viability, sterility, purity, impurities, identity, mycoplasma, and endotoxin.
Not included: GMP material cost, ancillary material cost, stability program, immuno-monitoring and contract for long-term liquid nitrogen storage.
Note: At Marker's request, there will be no Aseptic Process Simulation or Engineering Runs at this time.
See the proposed timeline in section 4 below.
Marker has also asked CellReady to provide general support services as follows:
● | Legacy Materials storage in LN2 tanks |
● | Storage of Cytokines |
● | Immuno monitoring assay |
● | Potency & Phenotyping assay |
● | Program Management |
● | IT services |
● | Document updates (MT-601) |
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
SECTION 3: PROPOSED STATEMENT
The table below summarizes the proposed scope of work for this Work Order #1. Please note that the scope of work and pricing is based on information provided to date and CellReady's understanding of the Client's needs. CellReady welcomes the opportunity to refine the scope of work as necessary to best meet the Client's objectives.
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
Batch release specifications
SECTION 4: ESTIMATED PROJECT TIMELINES
Length of engagement will be for [****] ([****]x) runs, with a projected processing time of 10 days, plus QC time [****] days. Total [****], from Apheresis receipt to shipment readiness.
Work Order Start Date: 1 January 2024
Work Order End Date: 31 March 2024
Scheduling:
GMP Manufacturing activities timeline will be executed as per the plan below.
● | January 2024: Ox Patients |
● | February 2024: [****] Patient |
● | March 2024: [****] Patient |
Start Days (D0s) will be scheduled according to each patient's onboarding plan. [****].
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
SECTION 5: PRICING AND DELIVERABLES
Unless specified as materials cost, below cost summary includes labor and overhead for CellReady to execute and deliver on the below items.
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Portions of this exhibit have been redacted pursuant to Item 601(b)(2) of Regulation S-K as (i) not material and (ii) likely to cause competitive harm if publicly disclosed. Omissions are designated as “****”. The Company hereby undertakes to furnish unredacted copies of this exhibit upon request by the Securities and Exchange Commission; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for such unredacted copies of this exhibit.
CellReady
PAYMENT SCHEDULE
GMP Manufacturing Services: 50% of the total service cost is due at signing with 50% to be billed upon completion of services.
Pass-through Costs: All pass-through costs, including raw materials, supplies, or other consumables, outsourced testing, shipping and handling, and storage beyond R&D timelines will be billed at the end of the WO with an added [****]% procurement fee. Upon completion of Project Activities of this Work Order, CellReady will provide a reconciliation to Marker of prepaid raw material costs against actual costs and issue an invoice or credit note to Marker equal to the variance between the two.
Payment Schedule: Unless otherwise agreed in writing, payment shall be due net thirty (30) days from the date of the invoice.
MANUFACTURING SERVICES AGREEMENT, IT AGREEMENT AND QUALITY AGREEMENT
A Manufacturing Services Agreement (MSA), [****] and a Quality Agreement (QA) have been established between CellReady and Marker, which detail the terms and conditions under which the companies agree to operate.
CONFIDENTIALITY AND COMMUNICATION
Under the current CDA in place between Marker and CellReady, the pricing listed in this proposal is confidential. CellReady will operate in accordance with the CDA and treat all details related to this project as strictly confidential.
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