Exhibit 10.1
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Fourth Amendment Agreement
This fourth amendment agreement (“Agreement”) is dated the date of the last signature below
PARTIES
BACKGROUND
AGREED TERMS
In this Agreement, expressions defined in the LSA and used in this Agreement have the meaning set out in the LSA unless otherwise defined. The rules of interpretation set out in the LSA apply to this Agreement.
In consideration of the mutual promises set out in this Agreement, the Parties agree to amend the LSA as set out below.
1
“Affiliate” means any person, firm, trust partnership, corporation, company or other entity or combination thereof which directly or indirectly (i) controls a Party, (ii) is controlled by a Party, or (iii) is under common control with a Party. As used in this definition, the terms “control” and “controlled” will mean ownership of 50% or more the voting rights of such entity or the power to direct the management of such entity through contract or otherwise. [***]
notwithstanding any change to any name and/or registered office with respect to any of the above, following execution of this Agreement, but at all times subject to the aforementioned criteria in this clause 1.1(d).”
“Subcontracting”. OXB shall be entitled to subcontract its obligations under this Agreement, in whole or in part, to the subcontractors approved by Client in advance as specified in the Quality Agreement (or, with respect to non-cGMP Services, to the approved subcontractors as set out in the applicable Scope of Work) (such subcontractors collectively, the “Approved Subcontractors”). OXB shall ensure that all Approved Subcontractors are bound by obligations to perform which are consistent with the terms of this Agreement, including, as applicable, confidentiality, quality assurance and regulatory obligations. OXB shall remain responsible for the performance of any subcontracted responsibilities and shall be liable for the acts and omissions of all of its subcontractor(s) in connection with performance under this Agreement as if such acts or omissions were performed by OXB; provided always that, for the avoidance of doubt, OXB shall not have any greater liability to Client than it would have under this Agreement than if OXB had carried out such work and/or committed such breach causing the liability itself. For clarity, the provisions herein with respect to subcontractors shall not apply to individuals engaged by OXB or its Affiliates as personnel enhancement contractors in the ordinary course of business to perform functions on behalf of OXB or its Affiliates that are generally performed by the employees of OXB or its Affiliates within the Facility.
“Additional Target Fee”. In partial consideration for the rights and licences granted to Client under this Agreement in relation to any Additional Target included
2
as a Target pursuant to clause 2.4, Client shall pay to OXB a, non-refundable, non- creditable payment identified in Schedule 2 (each an “Additional Target Fee”) in respect of each such Additional Target within [***].
“Aggregated Data”. The Parties agree that OXB’s use of Manufacturing data resulting from OXB’s performance under the Agreement may be collected, aggregated, stored, hosted, mined or otherwise utilized by OXB and its Affiliates and contractors, provided that any such Manufacturing data that relates to Client’s product(s), Client’s Confidential Information, or Client Materials (a) is anonymised and does not identify any individual or the Client or Client’s product(s), and (b) does not disclose any Client Confidential Information or Client Materials. Subject to the foregoing, OXB and its Affiliates hereby will and do have all right, title, and interest required to use said Manufacturing data for further research, development, and commercialization of OXB’s manufacturing systems, platforms, and services including externally for commercialization activities such as Intellectual Property Rights filings, marketing, and promotional activities related to manufacturing systems, platforms, and services provided said data is anonymized when used externally”
Royalties
Royalty rate if Vectors manufactured by OXB |
Royalty rate if Vectors manufactured by Client following Technology Transfer |
Royalty rate if Vectors manufactured by a Third-Party manufacturer following Technology Transfer |
[***] |
[***] |
[***] |
3
This Agreement has been entered into on the date stated at the beginning of it.
Signed for and on behalf of
OXFORD BIOMEDICA (UK) LIMITED
Signature: [***]
Name: [***]
Title: [***]
Date: 05-Jun-2024 | 16:11 BST
Signed for and on behalf of
CABALETTA BIO, INC
Signature: [***]
Name: [***]
Title: [***]
Date: 24 June 2024 | 7:03:54 AM PDT
4