Exhibit 10.19
MANUFACTURING SERVICES AGREEMENT
This Manufacturing Services Agreement (the “Agreement”) is made as of November 15, 2021, (the “Effective Date”) by and among Lonza Rockland, Inc., a Delaware corporation having offices at 191 Thomaston Street, Rockland, ME 04841 (“Lonza”), and Codiak BioSciences, Inc., a Delaware corporation having offices at 35 Cambridgepark Dr Suite 500, Cambridge, MA 02140 (“Codiak”) (each of Lonza and Codiak, a “Party” and, collectively, the “Parties”).
RECITALS
B. Codiak desires to have Lonza produce certain Exosome Products intended for therapeutic use in humans, and Lonza desires to produce such products.
C. Codiak desires to have Lonza conduct work for each Exosome Product according to individual Statement of Work, as further defined below.
D. Codiak and Lonza have entered into a License and Collaboration Agreement concurrently herewith (“License and Collaboration Agreement”), pursuant to which the Parties will establish a center of excellence to further develop and improve manufacturing technology relating to exosomes in accordance with the terms therein (the “Center of Excellence”).
NOW, THEREFORE, in consideration of the foregoing and the mutual promises and covenants hereinafter set forth, Lonza and Codiak, intending to be legally bound, hereby agree as follows:
AGREEMENT
When used in this Agreement, capitalized terms will have the meanings as defined below and throughout the Agreement. Unless the context indicates otherwise, the singular will include the plural and the plural will include the singular.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
3.1 Based on the information provided by Codiak, including process definition or changes developed by Lonza pursuant to any applicable Statement of Work, Lonza will prepare the Project Documentation for the Process in accordance with the respective Statement of Work. Codiak will inform Lonza of any specific requirements Codiak may have relating to the Project Documentation, including any information or procedures Codiak wishes to have incorporated therein. If Lonza intends to include in the Project Documentation the use of any assay, medium, or other technology that is not commercially available, Lonza will inform Codiak of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. The applicable Project Documentation, as set forth in the SOW, shall be completed and delivered by Lonza at completion of a Batch.
3.2 Codiak will cooperate with Lonza to assist Lonza to develop the Project Documentation and Process, including, to the extent in Codiak’s control or possession, by providing Lonza with additional information and procedures as may be reasonably required to create the Project Documentation, Process, which may include the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information.
3.3 Lonza will deliver a draft version of the applicable portions of the Project Documentation to Codiak for its review and approval in accordance with the schedule set forth in the Statement of Work. Codiak will notify Lonza in writing of any objections or comments it has to the draft Project Documentation, and upon such notification, representatives of Lonza and Codiak will meet promptly to resolve such objections and/or comments. Upon Codiak’s written acceptance of the draft Project Documentation, or in the event that Codiak does not submit a written notice setting forth Codiak’s objections or comments to the draft Project Documentation within [***] following receipt of such draft by Codiak, such draft will be deemed approved by Codiak.
3.4 The Process, Project Documentation, Specifications, Codiak Materials, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any Lonza Operating Documents (to the extent that Lonza Operating Document does not include Codiak Confidential Information), Lonza Inventions or Lonza Confidential Information included in any of the foregoing, will be deemed Codiak Confidential Information and subject to the provisions set forth in Article 10. Codiak shall
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
be permitted to use the Process or the Project Documentation for purposes of manufacture and commercialization of the Product, including applying for regulatory approvals of the Product; provided, however, that if the Process or the Project Documentation incorporates or contains any Lonza Intellectual Property or Lonza Confidential Information, prior to any disclosure of such Lonza Intellectual Property or Lonza Confidential Information to, or use by, a Third Party manufacturer, Codiak shall obtain Lonza’s written consent to such disclosure, not to be unreasonably withheld, conditioned or delayed.
10
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
For purposes of this Section 4.4, Lonza will use commercially reasonable efforts to repurpose or reallocate to another customer to mitigate such Cancellation Fee payable by Codiak.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
13
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
14
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
[***]
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Mailing address for wire transfer payments:
[***]
Please email remittance advice to: [***]
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Notwithstanding the foregoing, (i) any Confidential Information shall not be deemed to be within the foregoing exceptions merely because such information is embraced by more general information in the public domain or in the possession of the receiving Party, and (ii) any combination of features shall not be deemed to be within the foregoing exceptions merely because individual features are in the public domain or in the possession of the receiving Party, but only if the combination itself and its principle of operation are in the public domain or in the possession of the receiving Party.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Lonza hereby assigns to Codiak all of Lonza’s right, title and interest in and to such Codiak New IP. Lonza shall promptly disclose to Codiak in writing all Codiak New IP. Lonza shall execute, and shall cause its personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to execute, any documents reasonably required to confirm Codiak’s ownership of Codiak New IP, and any documents required to apply for, maintain and enforce any patent or other right in the Codiak New IP. If, as a result of any applicable Law, any Intellectual Property that would constitute Codiak New IP cannot be assigned to Codiak in accordance with the preceding sentence, Lonza hereby grants and shall cause its personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to grant, an exclusive, fully paid up, perpetual and irrevocable, sublicensable and transferrable license of their respective right, title and interest under such Intellectual Property to Codiak, subject to the license granted to Lonza in Section 11.2.1.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
For clarity, Lonza New IP shall not include any Codiak New IP. Codiak hereby assigns to Lonza all of Codiak’s right, title and interest in and to such Lonza New IP. Codiak shall promptly disclose to Lonza in writing all Lonza New IP. Codiak shall execute, and shall require its personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to execute, any documents reasonably required to confirm Lonza’s ownership of the Lonza New IP, and any documents required to apply for, maintain and enforce any patent or other right in the Lonza New IP. If, as a result of any applicable Law, any Intellectual Property that would constitute Lonza New IP cannot be assigned to Lonza in accordance with the preceding sentence, Codiak hereby grants and shall cause its personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to grant, an exclusive, fully paid up, perpetual and irrevocable, sublicensable and transferrable license of their respective right, title and interest under such Intellectual Property to Lonza, subject to the license granted to Lonza in Section 11.2.2.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
If to Lonza:
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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With a copy to:
[***]
If to Codiak:
[***]
Either Party may change its address for notice by giving notice thereof in the manner set forth in this Section 17.3.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date last signed by the parties hereto.
CODIAK BIOSCIENCES, INC.
November 12, 2021 By: /s/ Douglas E. Williams
Date Name: Douglas E. Williams
Title: CEO
LONZA ROCKLAND, INC.
November 13, 2021 By: /s/ Alberto Santagostino
Date Name: Alberto Santagostino
Title: SVP, Head of Cell and
Gene Technologies Business Unit
Signature Page to Manufacturing Services Agreement
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
APPENDIX A
STATEMENT OF WORK
[***]
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
APPENDIX B
Codiak’s Preexisting Contractual Obligations
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.