[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Exhibit 10.11
CVPF MASTER SERVICES ADDENDUM
This CVPF Master Services Addendum (“CVPF Addendum”) shall be effective as of the last day of signature below (“Addendum Effective Date”) and is subject to and incorporates the terms and conditions of the Master Translational Research Services Agreement by and between The Trustees of the University of Pennsylvania, a Pennsylvania nonprofit corporation (“PENN”), with offices located at [****], and Cabaletta Bio, Inc. (“Cabaletta Bio”), having a place of business at 501 Northwick Lane, Villanova, PA, 19085, dated as of October 19, 2018 (the “Agreement”). PENN enters this CVPF Addendum on behalf of its CVPF. To the extent rights and obligations attach to the CVPF hereunder, such rights and obligations shall be deemed to attach to PENN. PENN and Cabaletta Bio may be referred to herein as a “Party” or, collectively, as “Parties”. Capitalized terms used herein and not otherwise defined shall have the meanings ascribed thereto in the Agreement.
1.CVPF Services/Project Appendices. Upon and subject to the terms and conditions of CVPF Addendum, the CVPF shall perform certain Services (“CVPF Services”) in support the R&D Activities. The CVPF Services will comprise certain Projects and all Projects to be conducted by the CVPF hereunder shall be documented between the Parties in Project Appendices. Each Project Appendix shall relate to a particular Project and be attached to this CVPF Addendum. Each Project Appendix shall contain the following information: (i) Scope of Project/work plan, (ii) a Budget indicating the costs for CVPF effort as well as any additional costs that may be associated with the Project, (iii) if applicable, the type of products to be manufactured (iv) all materials to be transferred between the Parties. If called for in a Project Appendix, PENN shall perform engineering runs in accordance with this CVPF Addendum and the applicable Project Appendix, including, without limitation, the applicable schedule set forth in the applicable Project Appendix.
2.Disclaimer of Warranty/No Guarantee of Manufacture; Remedies. THE PARTIES UNDERSTAND AND AGREE THAT THE DISCLAIMER OF WARRANTIES CONTAINED IN SECTION 7.2 OF THE AGREEMENT APPLIES FULLY TO THE CVPF SERVICES TO BE PERFORMED HEREUNDER. Subject to the disclaimers of Section 7.2 of the Agreement, the Parties understand and agree that, to the extent product manufacturing or engineering runs are included within the scope of a particular Project, the CVPF shall use reasonable efforts to conduct such engineering runs or manufacture products according to, as applicable, specifications agreed to in writing by the Parties or applicable CVPF process or procedure. Such CVPF process or procedure, for clarity, is PENN Information. Notwithstanding the foregoing or anything contrary in the Agreement and this Addendum, given the experimental nature of the products to be developed and manufactured hereunder, the Parties understand and agree that the CVPF cannot guarantee the development or manufacture of any product or products. In addition, the Parties understand and agree that the Projects to be performed hereunder, and any products to be developed and manufactured hereunder, are developed for [****] and are therefore unique, cutting edge, and in some cases not well understood. Consequently, unexpected results may occur and, for numerous reasons, the CVPF may not be able to develop and manufacture products at all or in conformance withagreed-to specifications.
3.Payment in the Event of aNon-Conforming Product. The CVPF shall promptly notify Cabaletta Bio if the CVPF finds, [****], that it will not be able to develop and/or manufacture and/or release a product covered by an applicable Project Appendix, and in such event the CVPF shall discuss with Cabaletta in good faith the reasons for such failure. [****]
4.Subcontracted Services. Cabaletta Bio acknowledges and agrees PENN may subcontract with a vendor (each, a “Subcontractor”) for various components of development, manufacturing, and production, including by not limited to, the quality control testing component of the development, manufacturing, and production, with Cabaletta Bio’s prior written consent.
5.Ownership and Technology Transfer.