EX-4.21 3 exhibit421.htm EX-4.21 exhibit421
Lonza mesoblast [CERTAIN INFORMATION IN THIS EXHIBIT IDENTIFIED BY [***] IS CONFIDENTIAL AND HAS BEEN EXCLUDED BECAUSE IT (I) IS NOT MATERIAL AND (II) THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS THAT INFORMATION AS PRIVATE OR CONFIDENTIAL.] AMENDED AND RESTATED MANUFACTURING SERVICES AGREEMENT This Amended and Restated Manufacturing Services Agreement (this “Agreement”) is made as of June 27, 2025 (the “A&R Effective Date”) between Lonza Biosciences Singapore Pte. Ltd., a Singapore company having a principal place of business at 35 Tuas South Avenue 6 Tuas, Singapore 637377 (“LONZA”), and Mesoblast International Sàrl, a Swiss societé a responsibilité limitée having a place of business at Route de Pre-Bois 20, c/o Accounting & Management Service SA, 1217 Meyrin, Switzerland (“CLIENT”) (each of LONZA and CLIENT, a “Party” and, collectively, the “Parties”). RECITALS A. The Parties entered into the Manufacturing Services Agreement dated as of October 9, 2019 (the “Effective Date”), as amended by that certain Amendment No. 1 dated March 31, 2022 (as amended, the “Original Manufacturing Services Agreement”), and now wish to amend and restate the Original Manufacturing Services Agreement in its entirety as set forth herein, with effect from the A&R Effective Date. B. The Parties wish to terminate the 2011 Agreement (as defined below). C. LONZA operates the Facility (as defined below). D. CLIENT desires to have LONZA produce certain of CLIENT’s products, including CLIENT’s pediatric Graft versus Host Disease product, remestemcel-L, allogenic mesenchymal precursor cells, and/or cell banks, and LONZA desires to produce such product(s). E. CLIENT may desire to have LONZA conduct work according to individual Statements of Work or Purchase Orders, as further defined below. NOW, THEREFORE, in consideration of the foregoing and the mutual promises and covenants hereinafter set forth, LONZA and CLIENT, intending to be legally bound, hereby agree as follows: AGREEMENT 1. DEFINITIONS 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. 1.1 “Acceptance Period” has the meaning set forth in Section 6.2.1. Exhibit 4.21


 
2 1.2 “Additional Suite” has the meaning set forth in Section 7.9. 1.3 “Affiliate” means, with respect to either Party, any other corporation or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, the term “control”, and, with correlative meanings, the terms “controlled by” and “under common control with” means direct or indirect ownership of more than fifty percent (50%) of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such entity or the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, or otherwise. 1.4 “Applicable Law” means (a) all applicable federal, state and local laws, statutes, rules, regulations, and ordinances in the Territory, Singapore and any other jurisdiction agreed to by the Parties, as well as requirements of any Regulatory Authority in each such jurisdiction; and (b) GMPs, as applicable; in case of both (a) and (b), together, with any and all amendments thereto, and in each case, as applicable to the manufacture and supply (i.e. including all associated packaging, labeling, quality assurance and control, storage, handling, importation and transportation) of Product and the conduct of the Process. 1.5 “Background Intellectual Property” means any Intellectual Property either (a) owned or controlled by a Party on or prior to the Effective Date, or (b) developed or acquired by a Party independently of its performance under this Agreement, other than Intellectual Property developed through the use of Confidential Information of the other Party. For clarity, as of the A&R Effective Date, the Process, Master Production Record and Specifications are Background Intellectual Property of CLIENT and do not contain any material LONZA Intellectual Property or LONZA Confidential Information, [***]. 1.6 “Batch” means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. 1.7 “Batch Documentation” means the compilation of documentation generated by LONZA in preparation of and during the performance of manufacturing a Batch pursuant to a Purchase Order, including, without limitation, executed Batch Records, component records, test records and test record forms, certificates of analysis, study protocols, study summary reports, deviation reports, laboratory investigations, records of environment excursions, formulation records, documentation regarding LONZA’s performance of the Process and other related documents. 1.8 “Batch Record” means the production record pertaining to a Batch. 1.9 “Binding Portion” has the meaning set forth in Section 7.2. 1.10 “Biologics License Application” or “BLA” means a biologics license application for a Product, any equivalent successor filing thereto filed with the FDA, and any supplements or amendments to any of the foregoing.


 
3 1.11 “Business Day” means any day except a Saturday, Sunday or any other day on which commercial banks in Singapore, Basel, Switzerland or Melbourne, Australia are authorized or required by law to remain closed. 1.12 “Campaign” means (a) a series of [***] forecasted and ordered in accordance with this Agreement for manufacture by LONZA within a Contract Year; provided that the series of [***] shall be pro-rated for any Contract Year in which there is a ramp-up or ramp-down in accordance with the terms hereof or (b) such other number of Slots as otherwise agreed by the Parties in writing. 1.13 “Cancellation Payment” has the meaning set forth in Section 7.5. 1.14 “cGMP” or “GMP” means the applicable regulatory requirements, as amended from time to time, for current good manufacturing practices, including without limitation those promulgated by a Regulatory Authority including by (a) the FDA under the United States Federal Food, Drug and Cosmetic Act, 21 C.F.R. § 210 et seq., or (b) the European Medicines Agency or under the European Union guide to good manufacturing practice for medicinal products. 1.15 “cGMP Batch” means any Batch which is required under a Statement of Work or Purchase Order to be manufactured in accordance with cGMP. 1.16 “Change Order” has the meaning set forth in Section 2.2. 1.17 “CLIENT Intellectual Property” means all Intellectual Property owned or controlled by CLIENT including CLIENT’s Background Intellectual Property and CLIENT New IP. 1.18 “CLIENT Manufacturing Materials” has the meaning set forth in Section 2.3. 1.19 “CLIENT Materials” means the CLIENT Manufacturing Materials and the CLIENT Production Materials. 1.20 “CLIENT Materials Reports” has the meaning set forth in Section 2.3. 1.21 “CLIENT New IP” has the meaning set forth in Section 11.1.3. 1.22 “CLIENT Personnel” has the meaning set forth in Section 5.11.1. 1.23 “CLIENT Production Materials” has the meaning set forth in Section 5.3. 1.24 “CMO License Royalty” has the meaning set forth in Section 11.3.2. 1.25 “Confidential Information” has the meaning set forth in Section 10.1. 1.26 “Contract Year” means (a) with respect to the first Contract Year, the period beginning on the Initiation Date and ending on December 31, 2020, and (b) with respect to each subsequent Contract Year, the one (1) year period beginning January 1 of such year and ending


 
4 twelve (12) months thereafter, except that if the Term ends prior to the end of a Contract Year, the final Contract Year shall end on expiration or termination of the Term. 1.27 “Disapproval Notice” has the meaning set forth in Section 6.2.1. 1.28 “Discretionary Changes” has the meaning set forth in Section 5.9. 1.29 “Dispute” has the meaning set forth in Section 16.14.1. 1.30 “Engineering Batch” means a Batch that is intended to demonstrate the successful transfer of the Process to the Facility. 1.31 “Europe” means the countries that form the European Economic Area, as of the Effective Date and Switzerland. For the avoidance of doubt, the United Kingdom shall be deemed a member of the European Economic Area. 1.32 “Extended Term” has the meaning set forth in Section 14.1. 1.33 “Facility” means LONZA’s multi-client production facility located at 35 Tuas South Ave 6 Singapore 637377 (the “Singapore Facility”). Notwithstanding the foregoing, [***] the Facility shall be deemed to either mean, or include (together with the Singapore Facility), such Lonza Alternative Site, as applicable based on such election. 1.34 “Failed Product” has the meaning set forth in Section 6.4. 1.35 “FDA” means the U.S. Food and Drug Administration, and any successor agency thereof. 1.36 “Forecast” has the meaning set forth in Section 7.2. 1.37 “Force Majeure” has the meaning set forth in Section 16.3. 1.38 “FTE” means the equivalent of the work of one (1) appropriately qualified individual employee full time for one (1) Contract Year [***], provided that a single individual shall not be deemed more than one FTE. 1.39 “ICC Rules” has the meaning set forth in Section 16.14.1. 1.40 “Incorporated Technology” has the meaning set forth in Section 11.3.1. 1.41 “lndemnitee” has the meaning set forth in Section 15.3.1. 1.42 “lndemnitor” has the meaning set forth in Section 15.3.1. 1.43 [Reserved] 1.44 “Initial Facility Audit” has the meaning set forth in Section 8.2. 1.45 [Reserved]


 
5 1.46 “Initial Term” has the meaning set forth in Section 14.1. 1.47 “Initiation Date” means January 31, 2020. 1.48 “Insurance Policy” has the meaning set forth in Section 15.4. 1.49 “Intellectual Property” means all worldwide patents, copyrights, trade secrets, know-how and all other intellectual property rights, including all applications and registrations with respect thereto, including any such rights in and to any technology, know-how, materials, designs, ideas, inventions, improvements, devices, developments, discoveries, compositions, processes, methods or techniques, whether or not patentable or copyrightable, but excluding all trademarks, trade names, service marks, logos and other corporate identifiers. 1.50 “IP Dispute” has the meaning set forth in Section 16.15. 1.51 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 3.1. 1.52 “Latent Defect” has the meaning set forth in Section 6.2.2. 1.53 “LONZA New IP” has the meaning set forth in Section 11.1.2. 1.54 “LONZA Operating Documents” means the SOPs, standard manufacturing procedures, raw material specifications, protocols, validation documentation, and supporting documentation used by LONZA, such as those pertaining to environmental monitoring within a suite or otherwise in the Facility, for operation and maintenance of the Facility generally and LONZA equipment used in general in the process of producing Product, excluding any of the foregoing that are or were unique to or specifically developed for the Process and for the manufacture or supply of Product. 1.55 “LONZA Parties” has the meaning set forth in Section 15.2. 1.56 “Losses” has the meaning set forth in Section 15.1. 1.57 “Master Production Record” has the meaning set forth in Section 4.1. 1.58 “Materials” has the meaning set forth in Section 5.8. 1.59 “Minimum Binding Order” has the meaning set forth in Section 7.6. 1.60 “Minimum Supply Period” means, [***], provided that if CLIENT contributed to the costs or expenses of building out [***]. 1.61 “Mitigation Proceeds” has the meaning set forth in Section 16.16. 1.62 “MPC” means any allogenic mesenchymal precursor cells selected for, or a population of such cells that has been enriched for STRO-1 and/or STRO-3.


 
6 1.63 “MPC Product” means a pharmaceutical or medicinal product containing MPCs as the intended therapeutic agent, including without limitation such a product in a final packaged form and labeled for use in clinical trials or for commercial sale to end users. 1.64 “MSC Product” means CLIENT’s remestemcel-L product (Ryoncil) for treatment of steroid-refractory acute graft versus host disease in pediatric patients. 1.65 “Non-binding Portion” has the meaning set forth in Section 7.2. 1.66 “Permitted Recipients” has the meaning set forth in Section 10.4. 1.67 [***]. 1.68 “Process” has the meaning set forth in Section 4.1. 1.69 “Product” means, individually, as applicable (a) MSC Product, (b) MPC Product in the event of the execution of a respective SOW for MPC Product, or (c) a cell bank for either the MPC Product or MSC Product upon execution of a respective SOW for manufacturing of a cell bank for either the MPC Product or MSC Product, as specified from time to time. For the avoidance of doubt, certain provisions of this Agreement do not apply to cell banks and such provisions will also be set forth in an SOW, including but not limited to portions of Sections 5.4, 5.5, and 6.2.2. 1.70 “Production Schedule” has the meaning set forth in Section 7.3. 1.71 “Product Warranties” has the meaning set forth in Section 6.1. 1.72 “Project Documentation” means the compilation of documentation generated by LONZA in preparation of and during the performance of a given SOW and any documentation to be provided to CLIENT pursuant to an SOW. 1.73 “Purchase Order” has the meaning set forth in Section 7.4. 1.74 “Quality Agreement” has the meaning set forth in Section 5.7. 1.75 “Reasonable Commercial Efforts” means, with respect to a Party, [***] As appropriate consistent with the foregoing, Reasonable Commercial Efforts shall require the applicable Party to: [***]. 1.76 “Regulatory Approval” means, with respect to a Product and any jurisdiction in the Territory, receipt of all approvals, licenses, registrations or authorizations from applicable Regulatory Authorities necessary to market and sell such Product in the particular jurisdiction in the Territory, as applicable. 1.77 “Regulatory Authority” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the development, manufacture or commercialization (including approval of


 
7 Regulatory Approvals) of any pharmaceutical or medicinal product in the Territory or Singapore, or other jurisdictions as may be agreed to by the Parties. 1.78 “Release Time Period” has the meaning set forth in Section 5.4. 1.79 “Remaining Client Property” has the meaning set forth in Section 7.11. 1.80 “Required Changes” has the meaning set forth in Section 5.9. 1.81 “Response” has the meaning set forth in Section 7.2. 1.82 “Safety Stock” has the meaning set forth in Section 5.5. 1.83 “Senior Executives” has the meaning set forth in Section 3.1. 1.84 “Services” means the activities to be performed by LONZA under a Statement of Work, a Purchase Order or the Quality Agreement, including the manufacture of the Product and the provision of testing services, quality control services and storage services. 1.85 “Shortage of Supply” has the meaning set forth in Section 5.5. 1.86 “Slot” means the capacity in the applicable suite to: manufacture one (1) batch of MSC Product or MPC Product or perform one (1) aseptic process simulation run. 1.87 “SOP” means a standard operating procedure. 1.88 “Sourcing Plan” has the meaning set forth in Section 3.1. 1.89 “Specifications” means, with respect to a Product, specifications set forth in the certificate of analysis or as modified by the Parties, in writing, in connection with the manufacture of a particular cGMP Batch of such Product hereunder, [***]. 1.90 “Statement of Work” or “SOW” means a plan to perform pre-manufacturing activities, to further develop the Process, or to perform other Services, in each case, which is agreed upon by the Parties and attached hereto as an Appendix. It is contemplated that each separate project shall have its own Statement of Work. As each subsequent Statement of Work is agreed to and signed by the Parties, each shall state that it is to be incorporated and made a part of this Agreement and shall be consecutively numbered as A-1, A-2, A-3, etc. For clarity, the Parties anticipate that orders of MSC Product cGMP Batches will be made pursuant to Purchase Orders and not pursuant to SOWs. 1.91 “Taxes” has the meaning set forth in Section 9.4. 1.92 “Technology Transfer” has the meaning set forth in Section 4.2. 1.93 “Term” has the meaning set forth in Section 14.1. 1.94 “Territory” means [***].


 
8 1.95 “Third Party” means any person or entity other than LONZA, CLIENT or their respective Affiliates. 1.96 “Third Party Manufacturer” has the meaning set forth in Section 4.1. 1.97 “True-Up Payment” has the meaning set forth in Section 7.6. 1.98 “Warranty Dispute” has the meaning set forth in Section 6.3. 2. STATEMENTS OF WORK; PROCESS IMPROVEMENTS OR FURTHER DEVELOPMENT; TERMINATION OF 2011 AGREEMENT 2.1 Statement of Work. As requested by CLIENT, the Parties will collaborate to develop one or more Statements of Work, describing activities to be performed by LONZA or to be subcontracted by LONZA to Third Parties. Once agreed to in writing by the Parties, such Statement of Work shall be executed and signed by an authorized representative of each Party. Upon execution by both Parties, such Statement of Work is hereby incorporated herein by reference and made a part of this Agreement. Each Statement of Work shall provide for a work plan and an agreed estimated budget for such activities including scope of work to be performed, estimated timelines and deliverables. In the event of a conflict between the terms and conditions set forth in the body of this Agreement and any Statement of Work, the terms and conditions set forth in the body of this Agreement shall control unless such Statement of Work expressly states an intent to supersede this Agreement in a specific manner. Without limitation, it is anticipated that if the following activities are to occur, such activities will be subject to an SOW: (a) any CLIENT requests for LONZA to install, qualify and validate any equipment (including any labeler) specific for the performance of LONZA’s manufacturing and supply obligations hereunder, and (b) any training runs, engineering runs, process validation runs, and comparability runs. 2.2 Modification of Statement of Work. Should CLIENT want to change a Statement of Work or to include additional services to be provided by LONZA, CLIENT may propose to LONZA an amendment to the Statement of Work with the desired changes or additional services (“Change Order”). LONZA will use Reasonable Commercial Efforts to accept such Change Orders. If LONZA determines that it has the resources and capabilities to accommodate such Change Order, LONZA will prepare a modified version of the Statement of Work reflecting such Change Order (including, without limitation, any changes to the estimated timing, estimated charges or scope of a project) and will submit such modified version of the Statement of Work to CLIENT for review and comment. The modified Statement of Work shall be binding on the Parties only if it refers to this Agreement, states that it is to be made a part thereof, and is signed by both Parties, thereafter such modified version of the Statement of Work will be deemed to have replaced or amended the prior version of the Statement of Work. Notwithstanding the foregoing, if a modified version of the Statement of Work is not executed by both Parties, the existing Statement of Work shall remain in effect. 2.3 Materials for Performance of SOW. To the extent set forth in an SOW, within the time period specified in such SOW, each Party will procure the materials listed in the Statement of Work for which such Party is responsible. CLIENT will provide LONZA with (a) the materials


 
9 listed in the SOW which CLIENT is responsible for delivering to LONZA and any handling instructions, protocols, SOPs (to the extent not already provided) and other documentation necessary to maintain the properties of such materials for the performance of the Statement of Work, and (b) any protocols, SOPs and other information and documentation in possession or control of CLIENT and necessary for the performance of the Statement of Work, and for the preparation of the Project Documentation in conformance with cGMP, including, without limitation, process information, SOPs, development data and reports, quality control assays, raw material specifications (including vendor, grade and sampling/testing requirements), product and sample packing and shipping instructions, and product specific cleaning and decontamination information (collectively, the “CLIENT Manufacturing Materials”) as specified in such SOW or Production Documentation. If CLIENT does not provide the CLIENT Manufacturing Materials within the time period specified in the applicable SOW, [***]. Except as expressly granted herein, no licenses or rights in CLIENT Manufacturing Materials or any Intellectual Property therein shall be deemed granted by CLIENT to LONZA, its Affiliates or its Third Party contractors by implication, estoppel, or otherwise. All CLIENT Manufacturing Materials shall be used and maintained at the Facility or other site at which the applicable activities under a Statement of Work are performed. LONZA, its Affiliates and Third Party contractors shall only use the CLIENT Manufacturing Materials in compliance with all national, state, and local laws and regulations and solely for the purposes set forth in the SOW, and shall keep a record of CLIENT Manufacturing Materials received and used, discarded or otherwise consumed under and during the course of the applicable SOW (the “CLIENT Materials Record”). The CLIENT Materials Record and all CLIENT Manufacturing Materials shall be deemed Confidential Information of CLIENT. 2.4 Performance by LONZA. Subject to the provision by CLIENT of the CLIENT Manufacturing Materials pursuant to Section 2.3, LONZA will use Reasonable Commercial Efforts to perform, directly or, subject to the terms of the Statement of Work or written approval by CLIENT (such approval not to be unreasonably withheld), through a Third Party contractor, the work described in a Statement of Work in a professional and workmanlike manner in accordance with the terms of this Agreement and the applicable SOW. LONZA will use Reasonable Commercial Efforts to promptly notify CLIENT of any material delays that arise during the performance of the Statement of Work. Unless otherwise expressly provided in a Statement of Work, LONZA may not have any Services under a Statement of Work performed by any Third Party contractor unless LONZA obtains the prior written consent of CLIENT, which shall not be unreasonably withheld or delayed. LONZA will cause its Affiliates and Third Party contractors to comply with the provisions of this Agreement and the applicable Statement of Work in connection with such performance (including compliance with the applicable terms regarding Intellectual Property and confidentiality, and restrictions on the use and transfer of CLIENT Materials), and LONZA shall remain responsible to CLIENT hereunder for all activities of its Affiliates and Third Party contractors to the same extent as if such activities had been undertaken by LONZA itself; provided that if the Parties agree that LONZA will engage an external analytical laboratory to perform analytical laboratory services not offered by LONZA, [***]. However in such circumstances, at CLIENT’s request, LONZA will (a) lead appropriate fact finding (including conducting any audit) necessary to identify the root cause which led to the fact finding forum being constituted and (b) use Reasonable Commercial Efforts to enforce any of its rights/the laboratory’s obligations for and on behalf of CLIENT and otherwise reasonably cooperate with CLIENT to ensure the performance of such analytical laboratory’s obligations in accordance therewith.


 
10 2.5 Documentation and Reports. LONZA will prepare the Project Documentation, as agreed to by the Parties, in accordance with the Statement of Work and Applicable Laws. CLIENT will promptly inform LONZA of any specific requirements CLIENT may have relating to the Project Documentation, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. 2.6 Affiliates. An Affiliate of LONZA may execute a Statement of Work with CLIENT pursuant to this Agreement and submit invoices to CLIENT under such Statement of Work. In such circumstances, all references in this Agreement to LONZA shall be deemed to be to the applicable Affiliate of LONZA with respect to that particular Statement of Work, provided that if both LONZA and an Affiliate of LONZA execute a Statement of Work with CLIENT, all references in this Agreement to LONZA shall be deemed to be to LONZA and to the applicable Affiliate of LONZA with respect to that particular Statement of Work. [***] 2.7 Product Changeover. CLIENT shall have the right to elect, in writing, to have LONZA manufacture a different type of Product than the type of Product Lonza manufactured in the last Batch (“Product Change”); [***], CLIENT shall have the final determination on such election. CLIENT shall provide LONZA at least [***] prior written notice of such election, provided that (a) such [***] prior written notice assumes that CLIENT shall provide the necessary quantities of [***]. 2.8 Termination of 2011 Agreement. The Parties hereby acknowledge and ratify the termination in its entirety effective as of December 6, 2024 of that certain Manufacturing Services Agreement made as of September 20, 2011 between the Parties (together, with all prior, written amendments, if any, between the Parties, the “2011 Agreement”). The only ongoing Services related to the 2011 Agreement are the Services set forth in Statement of Work [***], which shall continue to be performed and shall be governed by this Agreement. 2.9 Releases; Covenants Not to Sue. 2.9.1 Release by CLIENT. Except as otherwise set forth in Section 2.9.5 below, CLIENT, on behalf of itself and its Affiliates, predecessors, successors, assigns, and each of their past and present employees, officers, directors, agents, representatives, and insurers, and all persons or entities acting by, through, or under them (collectively, the “CLIENT Entities”), hereby irrevocably releases, acquits, and forever discharges LONZA and LONZA’s Affiliates, predecessors, successors, assigns, and each of their past and present employees, officers, directors, agents, representatives, and insurers and all persons or entities taking by, through, or under them (collectively, the “LONZA Entities”) from [***] (collectively, “Claims”), which the CLIENT Entities now have or may have ever had, from [***] (collectively, the “Released Matters”). 2.9.2 CLIENT’s Covenant Not to Sue. Effective upon, but only upon, the execution and delivery of this Agreement, CLIENT, on behalf of itself and the CLIENT Entities, further covenants and agrees not to [***]. 2.9.3 Release by LONZA. Except as otherwise set forth in Section 2.9.5 below, LONZA, on behalf of itself and the LONZA Entities, hereby irrevocably releases, acquits, and forever discharges CLIENT and the CLIENT Entities from [***].


 
11 2.9.4 LONZA’s Covenant Not to Sue. Effective upon, but only upon, the execution and delivery of this Agreement, and subject to CLIENT’s compliance with the obligations set forth under Section 2.10 of this Agreement, LONZA, on behalf of itself and the LONZA Entities, further covenants and agrees not to [***]. 2.9.5 Release Exceptions. The releases by CLIENT and LONZA set forth in this Section 2.9 shall not apply to release any Party’s obligations or breach of obligations under (i) this Agreement, (ii) any Statement of Work, Purchase Order, or Quality Agreement with respect to such Statement(s) of Work and Purchase Order(s), each under the Original Manufacturing Services Agreement in effect as of the A&R Effective Date (which are listed on Exhibit 2.9.5 hereto), or (iii) all outstanding invoices for services performed in connection with the 2011 Agreement and/or the Original Manufacturing Services Agreement. [***]. 2.10 Upfront Fee. [***]. 2.11 Hiring and Training. Promptly after the A&R Effective Date, LONZA shall diligently [***].


 
12 3. PROJECT MANAGEMENT 3.1 Joint Steering Committee. Promptly after execution of this Agreement, the Parties shall establish a steering committee to oversee, review and coordinate the activities of the Parties under this Agreement (the “Joint Steering Committee” or “JSC”). Each Party shall name a mutually agreed upon equal number of representatives for the Joint Steering Committee, each of whom shall be a knowledgeable specialist in an appropriate discipline, provided that the Joint Steering Committee shall, at a minimum, consist of the head of operations of the Facility, the relevant divisional heads for each Party and a commercial representative. The Joint Steering Committee shall meet at least once per calendar quarter during the Term, or as otherwise mutually agreed by the Parties. The Joint Steering Committee shall [***] It being understood that the JSC will not unreasonably withhold, condition or delay approval of CLIENT employee’s observation in circumstances where there have been multiple failures which have not been shown to been fully addressed to CLIENT’s reasonable satisfaction acting in good faith. Each Party shall keep the other Party fully informed on a regular basis through the JSC of the activities for which it is responsible under this Agreement, including each Statement of Work. Decisions of the Joint Steering Committee shall be made by unanimity, with each Party having one vote. In the event that the Joint Steering Committee does not reach unanimity with respect to a particular matter, and the Joint Steering Committee is unable to resolve the dispute after endeavoring for [***] to do so, then (i) either Party may, upon written notice, refer such matter to the President of such Party’s respective business unit (or their designee having authority to resolve the dispute) (“Senior Executives”), for attempted resolution by good faith negotiations within [***] after such written notice, and (ii) if the Senior Executives do not reach resolution on such a matter within [***] after such notice, then [***]; provided, however, that [***]. If LONZA is unable to comply with any such decision due to good faith compliance concerns, technical or feasibility issues at the Facility, then LONZA shall notify CLIENT and either Party may refer such matter to arbitration pursuant to Section 16.14, and other matters that are not mutually agreed shall be referred to arbitration pursuant to Section 16.14. 3.2 Persons in the Plant. CLIENT shall be permitted to have, at no additional cost, for all runs during Campaigns for which the JSC has determined that observation is appropriate, [***] employee(s) at the Facility where activities are performed hereunder. Without limiting the foregoing, CLIENT shall at all times be permitted to observe within the suite(s) where the conduct of a Campaign for Product is ongoing via closed circuit television (with applicable angles) for the purpose of observing (including circumstances when CLIENT shall be permitted in the suite), reporting on, and consulting as to the performance under this Agreement, subject to the provisions of Section 5.11, and provided, further that such employees shall be subject to and agree to abide by confidentiality obligations to Third Parties and customary practices and operating procedures regarding persons in plant set forth in the LONZA Operating Documents. 3.3 Project Manager. With respect to each Statement of Work, each Party will appoint a project manager who will be responsible for overseeing day-to-day activities under such Statement of Work and be the principal point of contact between the Parties. 4. TECHNOLOGY TRANSFER


 
13 4.1 Initial Transfer. It is acknowledged and agreed that the process for manufacturing and supplying the Product (“Process”), including documentation containing a detailed description of the Process and instructions to be followed by LONZA in the production of the Product (“Master Production Record”), was developed by or on behalf of CLIENT and, for MSC Product only, has been transferred to LONZA prior to the Effective Date. For the avoidance of doubt, the Process and the Master Production Record are solely and exclusively owned by CLIENT. 4.2 Transfer to Third Party Manufacturer. Subject to the applicable purchase requirements set forth herein, including without limitation Sections 7.6 and 7.9, if CLIENT elects to use one or more alternative sources for manufacture and supply of the Product (each a “Third Party Manufacturer”), [***] in accordance with a mutually agreed plan (“Technology Transfer”). [***]. In addition, at CLIENT’s request, to the extent LONZA has exclusive purchase rights with respect to any Materials, [***]. [***]. 4.3 Incorporated Technologies. As of the Effective Date, CLIENT and LONZA acknowledge and agree that no material LONZA Background IP or Incorporated Technologies are used in the manufacture or supply of the Product or are reasonably necessary to facilitate performance of the Process or manufacture or supply of Product. 4.4 Transfer to Another LONZA Facility. If (a) CLIENT elects to have an alternative LONZA site in [***] (a “LONZA Alternative Site”) to replace the Facility as the location to perform the manufacture and supply of Product(s), and LONZA agrees on such LONZA Alternative Site (such agreement not to be unreasonably withheld, conditioned or delayed), (b) CLIENT elects to have a LONZA Alternative Site in addition to the Facility to perform the manufacture and supply of Product(s), and LONZA agrees on such LONZA Alternative Site (such agreement not to be unreasonably withheld, conditioned or delayed), or (c) LONZA elects, in its sole discretion, to have a LONZA Alternative Site replace the Facility as the location to perform the manufacture and supply of the Product, then, in each case of subsections (a)-(c), inclusive, LONZA shall transfer [***] (such transfer, a “LONZA Transfer”). LONZA, with the reasonable support of CLIENT, shall conduct each LONZA Transfer [***]. The Parties shall discuss and shall consider in good faith all relevant factors, [***]. In the event CLIENT elects to have a LONZA Alternative Site to replace the Facility in accordance with subsection (a) or to have a LONZA Alternative Site in addition to the Facility in accordance with subsection (b), [***]. In the event LONZA elects to have a LONZA Alternative Site in accordance with subsection (c), such LONZA Transfer, including CLIENT materials (except for cell banks), [***] and [***]; provided that [***]. In addition to the foregoing, in connection with a Lonza Transfer, the Parties shall mutually agree on a technology transfer protocol and related SOW with respect to such Lonza Transfer and if no protocol is finalized and SOW is executed within [***] of the date LONZA provides the first proposal of such protocol and SOW to CLIENT, then such matter shall be escalated to the Joint Steering Committee for attempted resolution. In the event that the Joint Steering Committee is unable to resolve the dispute within [***] of such escalation to the Joint Steering Committee, then either Party may, upon written notice, refer such matter to the Senior Executives for attempted resolution by good faith negotiations within [***] after such written notice. If the Senior Executives do not reach resolution on such matter within [***] after such notice, then either Party, may upon written notice, refer such matter to arbitration in accordance with Section 16.14.


 
14 5. MANUFACTURE OF PRODUCT; ORDER PROCESS; DELIVERIES 5.1 Engineering Batches. LONZA shall manufacture Engineering Batches in accordance with the Statement of Work or as requested by CLIENT, and agreed to by LONZA. Any Engineering Batch that meets the criteria set forth in the applicable Statement of Work, shall be deemed to be a successful Engineering Batch for purposes of Section 5.2. CLIENT shall have the right to make whatever further use of Engineering Batches that are not cGMP Batches as it shall determine in its sole discretion, provided that [***]. LONZA makes no warranty that [***]. 5.2 cGMP Supply. LONZA will, in accordance with the terms of this Agreement and the Quality Agreement, manufacture at the Facility and release to CLIENT, cGMP Batches that comply with the Process, cGMP and the Specifications, together with a certificate of analysis; provided, however, that cGMP manufacture shall not commence unless at least [***], unless otherwise agreed to by CLIENT. [***]. 5.3 CLIENT Deliverables. Within the time period set forth in Exhibit 5.3, for each Batch ordered by CLIENT pursuant to a Purchase Order and accepted by LONZA, CLIENT will provide LONZA with the materials required to be supplied by CLIENT for the manufacture of such Batch, as set forth in Exhibit 5.3 and any handling instructions, protocols, SOPs and other documentation (collectively, the “CLIENT Production Materials”) necessary to maintain the properties of such materials for the performance of manufacturing of such Batch. LONZA will not be responsible for any delays in manufacturing or supplying Product to the extent due to CLIENT’s failure to deliver the CLIENT Production Materials within the applicable time period set forth in Exhibit 5.3. In addition, CLIENT shall pay [***]. All CLIENT Production Materials shall be used and maintained at the Facility or other site at which the applicable activities under this Agreement are performed. LONZA, its Affiliates and Third Party contractors shall only use the CLIENT Production Materials in compliance with all Applicable Laws and solely for the purposes set forth in this Agreement, and shall keep a record of CLIENT Production Materials received and used, discarded or otherwise consumed under and during the course of manufacture and supply under this Agreement. 5.4 Manufacture and Supply by LONZA. LONZA will use Reasonable Commercial Efforts to manufacture and supply the Product and release to CLIENT the quantities of Product ordered by CLIENT pursuant to Purchase Orders (other than cell banks, which shall be as set forth in an SOW), all in accordance with the terms and conditions of this Agreement, including the Process, Specifications (other than for Engineering Batches), Master Production Record, Quality Agreement, Production Schedule and Applicable Laws. [***]. 5.5 Supply Protection. LONZA shall maintain a rotating inventory of the Materials and CLIENT shall maintain a rotating inventory of the required CLIENT Production Materials in the quantities set forth in Exhibit 5.5 (“Safety Stock”) (other than cell banks, which shall be set forth in an SOW) in each case consistent with the Sourcing Plan, and each Party will provide an inventory report to the other promptly on request. LONZA shall use Materials and CLIENT Production Materials on a “first-in, first-out” (FIFO) basis, including such Materials and CLIENT Production Materials in Safety Stock inventories. If LONZA anticipates that it will not be able to manufacture or supply any Product ordered by CLIENT in accordance with any Purchase Order accepted by LONZA in the quantities and by the estimated release dates set forth therein


 
15 (“Shortage of Supply”), LONZA shall promptly (and in any event within [***] notify CLIENT in writing of the same, and shall include in such notice its best estimate of the duration of the delay. LONZA shall use Reasonable Commercial Efforts to remedy any Shortage of Supply [***]. 5.6 Packaging and Shipping. LONZA will package and label the Product for shipment in containers in accordance with the Process, Specifications, Master Production Record, Quality Agreement and Applicable Laws in effect at the time of performance by LONZA. Each such container will be individually labeled with description of its contents, including any Product name, Batch number, quantity, and date of manufacture, and any other information reasonably required in order to trace the history of each Batch. LONZA will ship the Product [***] from the Facility. Notwithstanding that Products are shipped [***], LONZA agrees, [***]. CLIENT will provide to LONZA its account number with the selected carrier and [***]. Each shipment will be accompanied by the documentation listed in Exhibit 5.6, including without limitation, a certificate of analysis describing all current requirements of the Specifications and results of tests performed certifying that the Batch supplied has been manufactured, controlled and released according to the Specifications (other than for Engineering Batches) and Applicable Law. LONZA will promptly notify CLIENT if LONZA reasonably believes that it will be unable to meet an estimated delivery date. 5.7 Quality Agreement. Within [***] of the Effective Date, or such later date as agreed to by the Parties which shall be no later than [***] after the Effective Date, the Parties shall enter into a separate quality agreement, mutually agreeable to the Parties, containing terms and conditions standard and customary in the pharmaceutical industry, setting forth the Parties respective responsibilities for quality control and quality assurance with respect to Product (the “Quality Agreement”); provided that a Quality Agreement for cell banks shall be agreed to and executed in advance of commencement of GMP activities therefor. The Quality Agreement is not intended and should not be construed to limit any of the rights and obligations of the Parties set forth in this Agreement. If there is any conflict or inconsistency between the terms of the Quality Agreement and the terms of this Agreement, the terms set forth in this Agreement shall control except with respect to quality matters for which the Quality Agreement shall control. 5.8 Procurement of Materials. LONZA shall be responsible for the procurement of all raw materials and supplies (other than CLIENT Production Materials) necessary for the conduct of the Process or otherwise the manufacture and supply of Product (“Materials”) in accordance with requested estimated dates set forth in the Purchase Orders. [***] Shortage of Supply shall be addressed as set forth in Section 5.5. Materials shall be obtained from Third Parties in accordance with the Sourcing Plan. To the extent consistent with the Sourcing Plan, [***]. All Materials shall comply with the specifications applicable thereto as mutually agreed upon by the Parties and as set forth in current Batch Records or other appropriate documentation (provided that such specifications may only be amended upon CLIENT’s prior written approval). [***]. 5.9 Changes to Process or Specifications. [***]. If any delay to the manufacture or supply of Product is caused by any change described in the foregoing subsection (b), CLIENT shall [***]. Either Party may propose certain changes to the Specifications or the Process related to Product, which it reasonably believes will improve the manufacturing process [***] (“Discretionary Changes”). Each Party shall promptly notify the other Party regarding any such potential changes that it identifies pursuant to this Section. The Parties shall discuss through the


 
16 JSC (as provided in Section 3.1) which Discretionary Changes, if any, should be further developed or implemented. Notwithstanding the foregoing, LONZA shall [***]. If a Required Change or Discretionary Change results in any lost Slots based on the then applicable Binding Portion, then [***]. LONZA shall use Reasonable Commercial Efforts to reduce any such delay, provided that [***]. In addition to the foregoing, resources needed above and beyond the planned capacity of normal Manufacturing [***] shall [***]. 5.10 Records. LONZA will maintain accurate and complete records and samples relating to the manufacture and supply of the Product and conduct of the Process, as necessary to evidence compliance with this Agreement, the Quality Agreement and Applicable Law, including without limitation, the Master Production Record, all Batch Records, LONZA Operating Documents, certificates of analysis, quality control and laboratory testing and other data required by Applicable Laws. LONZA Operating Documents will remain LONZA Confidential Information. 5.11 CLIENT Access. 5.11.1 CLIENT’s employees and agents (including its independent contractors) (collectively, “CLIENT Personnel”) may observe the production of the Product as specified in Section 3.2 hereof. CLIENT Personnel working at the Facility will agree to and are required to comply with LONZA’s Operating Documents and any other applicable LONZA facility and safety policies. 5.11.2 CLIENT Personnel working at the Facility will be and remain employees of CLIENT, and CLIENT will be solely responsible for the payment of compensation for such CLIENT Personnel (including applicable Federal, state and local withholding, FICA and other payroll taxes, workers’ compensation insurance, health insurance, and other similar statutory and fringe benefits). CLIENT covenants and agrees to maintain workers’ compensation benefits and employers’ liability insurance as required by applicable Federal and state laws with respect to all CLIENT Personnel working at the Facility. 5.11.3 CLIENT will [***], provided CLIENT shall not be liable for repair or replacement costs resulting from ordinary wear and tear. 5.11.4 CLIENT Personnel visiting or having access to the Facility will abide by LONZA standard policies, operating procedures and the security procedures established by LONZA and provided to CLIENT which are in effect as of such visitation or access. CLIENT will be liable for [***]. In addition, CLIENT will reimburse LONZA for the cost of any lost security cards issued to CLIENT Personnel, at the rate of [***]. Upon LONZA’s request, CLIENT Personnel will sign a confidentiality agreement in the form to be mutually agreed by the Parties, such agreement not to be unreasonably withheld, conditioned or delayed by either Party. 5.11.5 CLIENT will indemnify and hold harmless LONZA from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) arising out of [***], except to the extent caused by the gross negligence or willful misconduct on the part of any LONZA personnel, in each case pursuant to the procedure set forth in Section 15.3.


 
17 5.11.6 Disclaimers. CLIENT acknowledges and agrees that LONZA Parties will not engage in any Product refinement or development of the Product, other than as expressly set forth in this Agreement or any Statement of Work. CLIENT acknowledges and agrees that LONZA Parties have not participated in the invention or testing of any Product, and have not evaluated its safety or suitability for use in humans or otherwise. 6. PRODUCT WARRANTIES; ACCEPTANCE AND REJECTION OF PRODUCT 6.1 Product Warranties. LONZA warrants that any Product manufactured by LONZA pursuant to this Agreement, at the time of release by LONZA pursuant to Section 5.4: (a) conforms to the Specifications (except with respect to Engineering Batches); [***]; (c) was manufactured in accordance with cGMP (except with respect to Engineering Batches), the applicable terms and conditions of this Agreement (including the applicable Statement of Work and Quality Agreement), and all Applicable Laws ((a), (b) and (c), collectively, the “Product Warranties”). 6.2 Approval of Completed Product. 6.2.1 Prior to each release to CLIENT by LONZA of Product to be supplied hereunder, LONZA will perform appropriate quality control procedures and inspections (including any such procedures and inspections specified in the Specifications therefor) to verify that such Product to be released conforms to the Product Warranties. When Product ordered by CLIENT is ready for such release, LONZA will notify CLIENT and supply CLIENT with the required documentation set forth in the Quality Agreement, [***] (the “Lonza First Step Release Documentation”). Within [***] after CLIENT’s receipt of such First Step Release Documentation (the “First Step Release Period”), [***]. Title and risk of loss to such Product shall pass to CLIENT at [***]. For the purposes of this Agreement, [***]. 6.2.2 LONZA shall store Product (other than cell banks, for which storage shall be as set forth in an SOW) accepted in accordance with Section 6.2.1 at CLIENT’s request for up to [***] following such acceptance [***]. Maximum storage duration shall not exceed [***] following LONZA’s release of the Product, and LONZA shall have no responsibility or liability for storing Product after [***] after release of the Product unless otherwise agreed by the Parties in writing. Product accepted in accordance with Section 6.2.1 shall be delivered to CLIENT or its designee in accordance with Section 5.6 above. CLIENT may reject all or part of the shipment within [***] of delivery by providing a Disapproval Notice as provided in Section 6.2.1. The shipment of Product shall be deemed accepted if CLIENT fails to reject the Product within such [***] period. [***]. 6.2.3 Stored Unreleased Product. For Product that cannot be released [***] (the “Stored Unreleased Product”), a storage fee of [***] (the “Storage Fee”) will be applied commencing on the [***] after the First Step Release Acceptance Period of such Stored Unreleased Product. Notwithstanding anything else contained in this Agreement, risk of loss or damage to the Stored Unreleased Product shall remain with [***]. 6.3 Dispute Resolution. LONZA and CLIENT will attempt to resolve in good faith any dispute regarding the conformity of Product with the Product Warranties (a “Warranty


 
18 Dispute”). If any Warranty Dispute cannot be settled within [***] of the submission by each Party of related paperwork and records to the other Party, then CLIENT will submit a sample of the disputed Product if required by an independent GMP expert of recognized repute which is selected by [***] for determination of the appropriate interpretation of analyses and results in the applicable paperwork and records pertinent to such Product, under quality assurance approved procedures, of the conformity of such Product with the Product Warranties, provided that if the Product has already been delivered to CLIENT or its designee, such independent expert shall determine the conformity of such Product with the Product Warranties at the time of release by LONZA to CLIENT or its designee. Such determination of the independent expert with respect to any Warranty Dispute shall be [***]. The costs associated with such analysis by such independent expert will be paid by [***]. 6.4 Remedies for Failed or Non-Conforming Product. In the event that the Parties agree, or an independent testing laboratory determines, pursuant to Section 6.3, that a Batch [***] fails to conform to the Product Warranties, or Product or CLIENT Materials are destroyed or damaged by LONZA Personnel other than a result of [***], due to the failure of LONZA personnel [***], (the “Failed Product”), then, [***], LONZA will, as soon as [***] (taking into account LONZA’s capacity to manufacture and supply Product) produce for CLIENT sufficient quantities of Product to replace the non conforming, damaged or destroyed portion of such Batch, in accordance with the provisions of this Agreement, [***], CLIENT acknowledges and agrees that [***] with respect to (i) the failure of Product to conform with any of the Product Warranties and (ii) damaged or destroyed CLIENT Materials and/or Product, is as set forth in this Section 6.4, and in furtherance thereof, CLIENT [***]. Unless Section 7.5 applies, in which case those Batches shall not count towards the [***] threshold set forth below, if LONZA fails to release (a) more than [***] of any Campaign within the Release Time Period plus [***] for the Batches in such Campaign due to failure of LONZA personnel [***], then the fees charged in accordance with Section 9.2 for such Campaign shall [***]. The Parties agree that the JSC shall determine in subsequent Calendar Years [***]. Other than the remedy for Failed Product, the rights set forth in this Section are in addition to any other rights set forth in this Agreement, including CLIENT’s rights under Section 14.2. 7. FORECASTS; PURCHASE REQUIREMENTS 7.1 Reserved. 7.2 Forecasts. Beginning no later than January 5, 2020, CLIENT shall supply LONZA [***] with a written rolling forecast showing CLIENT’s good faith estimated [***] requirements for Slots [***] for the following [***] period designated as one or more Campaigns (the “Forecast”). For manufacturing of Product in any suite, the amounts set forth in the first [***] of each Forecast will be binding on CLIENT [***] (such initial [***] of the Forecast, the “Binding Portion”). For manufacturing of Product, LONZA shall provide a response to the Forecast within [***] of receipt thereof specifying [***] (the “Response”), [***]. For clarity, in no event, may the Binding Portion or Response result in a requirement below the then-applicable Minimum Binding Order. The portion of each Forecast beyond the Binding Portion (i.e. the portions covering the [***]) (the “Non-binding Portion”) shall be provided in good faith based on CLIENT’s then- available information, but shall be nonbinding and is provided solely for planning purposes. Upon LONZA’s receipt of the Forecast, LONZA shall in good faith review the Non-binding Portion,


 
19 [***], and will notify CLIENT [***]. LONZA shall have no liability to CLIENT for [***]. Notwithstanding anything to the contrary in this Section 7.2, prior to July 1, 2027, CLIENT shall not order a Campaign of [***] Slots to be manufactured, and LONZA shall not be obligated to offer such a [***]-Slot Campaign. In addition to the foregoing, CLIENT shall provide LONZA [***]. Notwithstanding the foregoing, LONZA’s ability to ramp-up and hire headcount within timeframes set forth in the 2019 Agreement is an estimate and LONZA will use Reasonable Commercial Efforts to recruit and onboard headcount as efficiently as [***]. CLIENT acknowledges that LONZA may, despite exercising Reasonable Commercial Efforts, fail to hire and/or allocate exactly the number of additional headcount necessary to provide the Slots set forth herein, and CLIENT agrees that [***]. 7.3 Production Schedule. Without limiting LONZA’s obligation to fulfill Purchase Orders in accordance with the Binding Portion, LONZA shall determine and include in the Response the estimated schedule for production and release of Product (the “Production Schedule”) [***]. LONZA shall have the right to revise the Production Schedule, provided that such revisions do not advance or delay the commencement date for any Slot by more than [***] from the date set forth in the first Production Schedule provided by LONZA for such Slot unless otherwise agreed in writing by the Parties. 7.4 Binding Purchase Orders; Acceptance. CLIENT’s orders for Product shall be made pursuant to written purchase orders no later than [***] after receipt of the Response (including the Production Schedule), in the form attached hereto as Exhibit 7.4 (each a “Purchase Order”), specifying the quantity of Product ordered, [***]. CLIENT may order Slots in excess of those specified in the Binding Portion, in increments of [***] Slot, for delivery hereunder in accordance with the applicable Purchase Order subject to LONZA’s total capacity constraints and acceptance of such additional quantities. LONZA will accept or reject orders for Slots in excess of the number specified in the then current Binding Portion within [***] of receipt of the corresponding Purchase Order, provided that LONZA will use Reasonable Commercial Efforts to accept and fulfill such orders. If LONZA accepts any such order (or any portion thereof), the number of accepted excess Slots will be added to the Binding Portion. 7.5 Cancellation/Postponement. CLIENT may cancel any Purchase Order (or any portion thereof) upon written notice to LONZA subject to payment (within [***] after invoice from LONZA therefor) of [***] of the amount otherwise due for such cancelled order if such cancellation occurs less than [***] prior to the scheduled release of such order less any Mitigation Proceeds (the “Cancellation Payment”). [***]. 7.6 Minimum Binding Order. CLIENT agrees to be bound to order and purchase or direct its Affiliates or designees to order and purchase the following Product Slots (including related aseptic process simulation runs): (a) at least [***] Slots for [***], (b) at least [***] Slots for [***], (c) at least [***] Slots for [***], and (d) at least [***] Slots each [***] thereafter during the Term (each, the “Minimum Binding Order”). In addition to the foregoing, (a) in [***], if LONZA manufactures additional Product, CLIENT shall purchase [***] Product manufactured by LONZA up to, and including, [***] (subject to Section 9.7) and (b) when LONZA is manufacturing a Campaign of at least [***] Slots (or a pro-rated portion thereof for any Contract Year in which there is a ramp-up or ramp-down in accordance with the terms hereof), CLIENT shall purchase [***] Product manufactured by LONZA up to, and including, [***] in connection


 
20 with such Campaign at the per Slot price of [***] (subject to Section 9.7) (such additional Product, the “Additional Batches”). For the avoidance of doubt, unless expressly agreed in writing by the Parties, LONZA shall have no obligation to provide CLIENT with more than: (a) [***] Slots for [***], (b) [***] Slots for [***], (c) [***] (or a pro-rated portion thereof) Slots for [***], which amount shall be based on the Binding Portion, and (d) [***] Slots or [***] (or a pro-rated portion thereof) Slots for each [***] thereafter during the Term, which amount shall be based on the Binding Portion. If CLIENT, its Affiliates or designees do not order and purchase the respective Minimum Binding Order for each applicable [***], CLIENT shall be required after the end of such [***] to pay [***] (“True-Up Payment”) within [***] after CLIENT’s receipt of an invoice therefor. Notwithstanding the foregoing and without limitation of CLIENT's rights under this Agreement, the Minimum Binding Order shall be [***]. 7.7 Reserved. 7.8 [***]. Until the longer of (a) [***] and (b) the date [***] after [***] of [***] Slots, the manufacturing suite (i.e., suite 1) in the Facility will [***]. 7.9 Additional Capacity. If any Forecast would require LONZA to expand its capacity beyond [***] Slots per [***] period, then LONZA shall notify CLIENT in writing of the required expansion and the Parties will discuss the amount of additional capacity that is needed. If CLIENT elects, in its discretion, that additional capacity is required, then CLIENT shall notify LONZA in writing [***], the Parties will agree in advance to the prices per Slot which shall reflect a good faith negotiation [***]. 7.10 Pre-Production. LONZA will accept and store any CLIENT Materials, equipment or other property delivered pursuant to the Facility by CLIENT in accordance with the Sourcing Plan. [***] will be charged for the CLIENT Materials set forth in the Sourcing Plan during the period of time beginning [***] and ending [***]. 7.11 Post-Production. LONZA will store at the Facility (or other location mutually agreed by the Parties) [***] any in-process materials, CLIENT Materials, equipment and other CLIENT property (other than Product manufactured hereunder) that remains at the Facility (or such other location) on the date of completion of all manufacturing of the applicable Product as a result of the expiration or termination of this Agreement (collectively “Remaining CLIENT Property”), for up to [***]. If CLIENT has not provided any instructions as to the shipment or other disposition of Remaining CLIENT Property prior to the expiration of such [***], LONZA shall continue to store such Remaining CLIENT Property at the Facility or elsewhere and may notify CLIENT that LONZA intends to destroy such Remaining CLIENT Property; provided, however, that LONZA shall not destroy any Remaining CLIENT Property unless LONZA has first given CLIENT [***] advance written notice in order to permit CLIENT to arrange for the transfer or other disposition of such Remaining CLIENT Property; provided, further, that if CLIENT does not respond within such [***] period, then LONZA may dispose of such Remaining CLIENT Property. In the event that LONZA continues to store such Remaining CLIENT Property, CLIENT will pay to LONZA a storage charge at [***] for the period beginning on the [***] after the completion of the manufacturing of the applicable Product through the date that the storage terminates. [***].


 
21 8. REGULATORY MATTERS 8.1 Permits and Approvals. During the Term, LONZA will obtain and maintain any licenses, permits and approvals necessary for the manufacture and supply of the Product in the Facility and otherwise perform its obligations under this Agreement, and in the event of any failure to maintain such licenses, permits and approvals, shall use Reasonable Commercial Efforts to remedy such failure as expeditiously as possible. LONZA will promptly notify CLIENT if LONZA receives notice that any such license, permit, or approval is or may be revoked or suspended. 8.2 Pre-Commercial Manufacturing Audit. Up to one time prior to commencement of commercial manufacturing of Product upon not less than [***] prior written notice and during normal business hours for not more than [***], LONZA will permit CLIENT a maximum of [***] auditors to perform an initial qualifying audit of the Facility to verify compliance with cGMP and CLIENT’s quality requirements and perform pre approval and validation inspections (the “Initial Facility Audit”). CLIENT will make records of such Initial Facility Audit available for LONZA’s review. If the results of the Initial Facility Audit are not satisfactory, following discussion between the quality organizations of LONZA and CLIENT regarding any deficiencies, LONZA shall, under careful and good faith consideration, use its [***] discretion to implement corrective actions LONZA determines in its [***] discretion are appropriate to address the deficiencies, [***] and CLIENT shall be entitled to perform an additional on-site Facility audit with a minimum of [***] prior notice to ensure that such deficiencies have been resolved. Any and all costs related to deviations or modifications to the Facility requested or approved by CLIENT (outside of those to correct deviations from the requirements set forth in this Agreement, the applicable Statement of Work, Specifications, cGMP or Applicable Law or identified by any applicable Regulatory Authority, [***]) related to the manufacturing of Product will be [***]. Any audit set forth in this Section 8.2 shall be conducted during the normal business hours. 8.3 Ongoing Inspections/Quality Audit by CLIENT. Up to [***] per year upon not less than [***] prior written notice and during normal business hours, LONZA will permit CLIENT or its Affiliates a maximum of [***] auditors and [***] mutually agreed subject matter expert to inspect and audit, in each instance for not more than [***], unless otherwise agreed to by the Parties (a) the parts of the Facility where the manufacture of the Product is carried out, including the equipment used in the manufacturing, packaging, storage, testing, shipping or receiving of Product, Client Material or Material, and (b) relevant LONZA manufacturing and quality control records and all other documentation relating to manufacture and supply activities performed hereunder in order to assess LONZA’s performance of the Process and compliance with this Agreement, including the Quality Agreement and Applicable Laws, and to discuss relevant related issues with LONZA’ s management personnel. LONZA shall [***] cooperate with such audits, including by making appropriate LONZA personnel available to CLIENT’s auditors. CLIENT Personnel engaged in such inspection will abide by the terms and conditions set forth in Sections 5.11.4 and 10. In addition to the foregoing, CLIENT or its representatives shall have the right to perform “For Cause” audits at any time upon reasonable advance notice and during regular business hours (provided, however, that with respect to For Cause audits, LONZA shall use Reasonable Commercial Efforts to accommodate a shorter notice period if circumstances necessitate action on


 
22 a more expeditious time frame). If a For Cause Audit confirms that [***], the For Cause audits shall not be charged by LONZA; in all other cases LONZA shall charge [***]. 8.4 Inspections by Regulatory Authorities. Except as otherwise set forth in the Quality Agreement, LONZA will allow representatives of any applicable Regulatory Authority to inspect the relevant parts of the Facility where the manufacture and supply of the Product is carried out and to inspect the Master Production Record, Project Documentation and Batch Records to verify compliance with Applicable Laws, cGMP and other practices or regulations. LONZA will [***] notify CLIENT of the scheduling of any such inspection relating to the manufacture and supply of Product and will keep CLIENT informed about the results and conclusions of each such regulatory inspection relating to a Product, including actions taken by LONZA to remedy conditions cited in such inspections. In addition, LONZA shall allow CLIENT or its representative to assist in the preparation for and be present at such inspections relating to a Product or the conduct of the Process; provided that such presence shall be limited to (a) [***] and (b) [***], unless otherwise agreed by the Parties. LONZA will [***] send to CLIENT a copy of any reports, citations, warning letters or other correspondence received by LONZA from any Regulatory Authority in connection with an inspection or audit to the extent such documents relate to or affect the manufacture or supply of the Product (including those relating to general Facility compliance and the like). Prior to responding to any reports, requests, directives or other communications issued by any Regulatory Authority relating to a Product or its manufacture, [***], LONZA shall provide CLIENT a copy of its proposed response for CLIENT’s review and comment and LONZA shall take under careful and good faith consideration and use its [***] discretion to implement any comments or recommendations provided by CLIENT with respect thereto prior to submitting such response to the applicable Regulatory Authority. 8.5 Support for Regulatory Approvals. As requested by CLIENT from time to time and [***], LONZA shall reasonably cooperate with and provide assistance to CLIENT or its designee in connection with the preparation, submission and maintenance of regulatory applications and other filings to the FDA and other applicable Regulatory Authorities to obtain and maintain Regulatory Approvals for the Product. Accordingly, LONZA shall promptly provide to the applicable Regulatory Authority on behalf of CLIENT as requested, [***], with all information in LONZA’s control necessary for CLIENT to apply for, obtain, and maintain Regulatory Approvals in any country in the Territory (and such other countries as agreed by LONZA, such agreement not to be unreasonably withheld, conditioned or delayed) for the Product, including when necessary information relating to the Facility, or the equipment, Process, [***] used in the manufacture, processing and supply of such processing of such Product. Without limiting the foregoing, [***] In connection with a filing for Regulatory Approval of the Product, and securing and maintaining such Regulatory Approval, LONZA will provide necessary LONZA Confidential Information directly to the Regulatory Authority when possible, and to the extent that LONZA cannot so provide such LONZA Confidential Information, then such documents will be provided under strict confidentiality (subject to the confidential restrictions set forth herein) to the appropriate persons (regulatory affairs) at CLIENT for submission to the applicable Regulatory Authority. Further, LONZA agrees, at CLIENT’s request and [***], to execute, acknowledge and deliver such further instruments and take such other actions, all as promptly as possible, which may be necessary or appropriate to assist in the filing for, preparation, submission and maintenance of such Regulatory Approvals for the Product. For the avoidance of doubt, CLIENT may reference Confidential Information of LONZA, subject to this Section 8.5, which Confidential Information


 
23 will be provided directly by LONZA to the applicable Regulatory Authority to extent possible or if not possible will be provided to CLIENT as set forth in this Section 8.5, related to the manufacture of the Product in CLIENT’s regulatory filings with Regulatory Authorities as reasonably necessary to facilitate the manufacture, development or commercialization of the Product. Notwithstanding anything to the contrary herein, LONZA shall [***], at CLIENT’s request, [***] for expenses paid by CLIENT for LONZA’s cooperation with and provision of assistance to CLIENT or its designee in connection with [***]. Such [***] shall expire the earlier of (i) [***] or (ii) termination of this Agreement. 8.6 Recalls. Each of CLIENT and LONZA will immediately inform the other in writing if it believes any Product should be subject to recall from distribution, withdrawal or some other field action. CLIENT shall have the final decision-making authority as to any such recall or field action with respect to the Product and the sole right to initiate any such recall or field action. Upon request from CLIENT, LONZA shall assist CLIENT, [***], in any recall of Product, [***]. If a recall of any Product arises out of or results from: (i) [***], or (ii) [***], LONZA shall bear [***]. For the avoidance of doubt, CLIENT shall bear [***], except to the extent otherwise provided in the foregoing sentence. 8.7 Facility Renovations. Without limiting any of the Parties’ rights or obligations under Section 8.2, LONZA shall perform all renovations and modifications to the Facility required [***], in each case, necessary or relating to [***]; provided, however, LONZA shall inform CLIENT, in writing, of all changes [***] prior to making such changes and consider in good faith any written comments CLIENT has to such proposed changes; provided, further, however, [***]. LONZA shall use Reasonable Commercial Efforts to complete the renovations [***] (a) for the manufacturing suite at the Facility in Singapore prior to [***]; and (b) for the media suite at the Facility in Singapore by [***]. 9. FINANCIAL TERMS 9.1 Payments. CLIENT will make payment to LONZA in the amount set forth in an undisputed invoice within [***] of receipt of such an invoice from LONZA pursuant to Section 9.2 below. Any dispute relating to the amount of an invoice shall be made in good faith by CLIENT and resolved in accordance with Section 16.14 and CLIENT will pay to LONZA the amount of such disputed amount that has been resolved in favor of LONZA within [***] of final resolution of such dispute. Further, in addition to all other remedies available to LONZA (including the right to issue a material breach notice for failure to pay an undisputed invoice within [***] of the applicable due date), in the event that CLIENT has not paid an undisputed invoice within [***] of the applicable due date, LONZA may elect to suspend, upon prior written notification to CLIENT, the provision of all or a portion of the Services under this Agreement, [***], and any Statement of Work during any such suspension. 9.2 Pricing and Schedule. LONZA will charge fees for the manufacture and supply of Product for each Campaign in accordance with the amounts set forth in Exhibit 9.2 of this Agreement (subject to Section 9.7) according to the following schedule: (a) [***] of fees for such Campaign upon LONZA’s receipt of the first Purchase Order for such Campaign; provided that if no Purchase Order is sent, then [***] prior to the commencement date of the applicable Campaign; and (b) a [***] reconciliation payment of the remaining [***] of the fees for such


 
24 Campaign shall be due upon LONZA’s disposition of Batches or completion of aseptic process simulation runs, if any, in accordance with this Agreement; provided that, with respect to any Additional Batches purchased by CLIENT pursuant to Section 7.6, the applicable fee for such Additional Batches shall be payable as follows: (i) [***] of such fee shall be payable upon thaw of the Additional Batches, and (ii) the remaining [***] of such fee shall be payable [***] after LONZA’s disposition of the Additional Batches. The prices per Slot set forth in Exhibit 9.2 (i) are based on the number of Slots ordered by CLIENT and not the number of Batches released by LONZA and CLIENT shall pay for all such Slots in accordance with the terms hereof, except that in the event of a Failed Product Section 6.4 shall apply, and (ii) are inclusive of [***]. LONZA will charge for any other Services or Materials in accordance with the applicable Statement of Work, provided that for Services or Materials set forth only in a Statement of Work, LONZA shall inform CLIENT in writing [***]. 9.3 Invoices. In accordance with the schedules set forth in this Agreement or the applicable Statement of Work, LONZA, or its designee, will provide CLIENT with an invoice setting forth a detailed account of any such fees, expenses or other payments payable by CLIENT under this Agreement for the same month. LONZA will deliver reasonably detailed invoices, electronically by email, which shall be considered to be an original invoice. Invoices should be e- mailed to [***], and/or to such other e-mail address(es) as CLIENT may stipulate in writing from time to time. LONZA will not deliver a paper invoice unless requested by CLIENT. The price shall be invoiced to CLIENT in US Dollars. 9.4 Taxes. CLIENT agrees that it is responsible for and will pay [***] (the “Taxes”) resulting from LONZA’s production of Product under this Agreement [***]). To the extent not paid by CLIENT, CLIENT will indemnify and hold harmless LONZA from and against [***]. [***]. LONZA will not collect any [***] from CLIENT in connection with the production of any Product hereunder if CLIENT provides to LONZA the appropriate valid exemption certificates. 9.5 Interest. Any fee, charge or other payment due to LONZA by CLIENT under this Agreement that is not paid within [***] after it is due will accrue interest on [***] at a rate of [***] (or the maximum legal interest rate allowed by applicable law, if less) from and after such date. 9.6 Method of Payment. Except as otherwise set forth in Section 9.2, all payments to LONZA hereunder by CLIENT will be in United States currency and will be by check, wire transfer (to a bank account designated by LONZA reasonably in advance), money order, or other payment method approved by LONZA. Please email remittance advice to [***]. 9.7 Cost Adjustments. Except as expressly set forth herein, the costs and rates for manufacture and supply of Product shall [***] for [***] during the Term. 9.7.1 Effective as of [***], LONZA may increase Slot pricing set forth in Exhibit 9.2 by [***]. Then beginning on [***], and [***] thereafter, LONZA may increase Slot pricing set forth in Exhibit 9.2 by [***] of the previous [***] pricing. 9.7.2 In addition to the foregoing, the then-current Slot pricing may be changed by LONZA, upon reasonable prior written notice to CLIENT not less than [***] in advance of implementing any change described below (providing reasonable detail in support thereof), to


 
25 reflect [***]. If requested by CLIENT, LONZA agrees to reasonably discuss any such increase with CLIENT, [***]. Notwithstanding the foregoing, (a) LONZA may not adjust, in accordance with this Section 9.7(b), [***], and (b) [***]. 9.8 Financial Records and Audit Rights. 9.8.1 Books and Records. LONZA shall keep complete, true and accurate books of accounts and detailed records with respect to all Services performed under this Agreement. All such books and records shall be maintained for a period of [***] following the relevant calendar year to which such records pertain. 9.8.2 CLIENT Audit Rights. During the Term and the record-keeping period set forth in Section 9.8.1 above, [***]. 9.8.3 Reserved. 10. CONFIDENTIAL INFORMATION 10.1 Definition. “Confidential Information” means all information (including without limitation technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, specifications, data, results and other material, pre-clinical and clinical trial results, manufacturing procedures, test procedures and purification and isolation techniques, and any tangible embodiments of any of the foregoing, and any scientific, manufacturing, marketing and business plans, any financial and personnel matters relating to a Party or its present or future products, sales, suppliers, customers, employees, investors or business), that has been disclosed by or on behalf of such Party or such Party’s Affiliates to the other Party or the other Party’s Affiliates either in connection with the discussions and negotiations pertaining to this Agreement or in the course of performing this Agreement. Without limiting the foregoing, the terms of this Agreement will be deemed “Confidential Information” of each Party and will be subject to the terms and conditions set forth in this Article 10. [***]; and information contained in the LONZA Operating Documents and LONZA Intellectual Property will be deemed “Confidential Information” of LONZA, and in each case, will be subject to the terms and conditions set forth in this Article 10. 10.2 Exclusions. Notwithstanding the foregoing Section 10.1, any information disclosed by a Party to the other Party will not be deemed “Confidential Information” to the extent that such information: (a) at the time of disclosure is in the public domain; (b) becomes part of the public domain, by publication or otherwise, through no fault of the Party receiving such information; (c) at the time of disclosure is already in possession of the Party who received such information, as established by contemporaneous written records;


 
26 (d) is lawfully provided to a Party, without restriction as to confidentiality or use, by a Third Party lawfully entitled to possession of such Confidential Information; or (e) is independently developed by a receiving Party without use of or reference to the other Party’s Confidential Information, as established by contemporaneous written records. 10.3 Disclosure and Use Restriction. Except as expressly provided herein, the Parties agree that for the term of the Agreement and the [***] period following any termination or expiration of the Agreement, each Party and its Affiliates will keep completely confidential and will not publish or otherwise disclose any Confidential Information of the other Party, its Affiliates or sublicensees, except in accordance with Section 10.4. Notwithstanding the foregoing, to the extent Confidential Information is identified as a trade secret of the disclosing Party, the obligations set forth in this Section 10.4 shall survive with respect to such Confidential Information for so long as such Confidential Information remains a trade secret under applicable law or the maximum period of time otherwise allowed by applicable law. Neither Party will use Confidential Information of the other Party except as necessary to perform its obligations or to exercise its rights under this Agreement. 10.4 Permitted Disclosures. Each receiving Party agrees to take at least those measures that it employs to protect its own confidential information of a similar nature (and in no event less than reasonable care) to protect the secrecy of and avoid disclosure and unauthorized use of the Confidential Information of the disclosing Party, including without limitation to limit disclosure of the disclosing Party’s Confidential Information to its Affiliates and each of its and their respective officers, directors, employees, agents, consultants, advisors and independent contractors, actual or potential acquirers or licensees, each having a need to know such Confidential Information for purposes of this Agreement, as long as the primary business of any such potential acquirer or licensee is not directly competitive with LONZA (i.e., being primarily a contract manufacturing business) and CLIENT reasonably believes that it will consummate a transaction with such acquirer or licensee (“Permitted Recipients”); provided that such persons or entities and each of its and their respective officers, directors, employees, agents, consultants and independent contractors are informed of the terms of this Agreement and are subject to written or otherwise legally enforceable obligations of confidentiality, non-disclosure and non-use no less restrictive in scope than those set forth herein and for a reasonable time period similar to those set forth herein and provided further that the receiving Party shall be fully liable for any and all breaches by its Permitted Recipients. Each Party shall have the right to disclose the Confidential Information of the other Party in its regulatory filings and other communications with Regulatory Authorities in connection with the manufacture, development and/or commercialization of Product, and otherwise (subject to Section 10.5 below, if applicable) to the extent reasonably necessary to comply with Applicable Law, including securities laws, regulations or guidance, or with applicable rules of a public stock exchange; provided that, the receiving Party notify the disclosing Party as soon as possible so as to provide the disclosing Party an opportunity to review the disclosure obligation (including proposing redactions), and in the case of Confidential Information to be included in regulatory filings or in communications with Regulatory Authorities, to redact unnecessary Confidential Information in such disclosure or in the case of other such disclosures, to provide the disclosing Party the opportunity to either challenge or limit the


 
27 disclosure obligation. Confidential Information that is disclosed as required by Applicable Law or by judicial or administrative process shall remain otherwise subject to the confidentiality provisions of this Article 10, and the Party so disclosing the Confidential Information shall (a) take all steps reasonably necessary, including seeking to obtain an order of confidentiality, to endeavor to ensure the continued confidential treatment of such Confidential Information and (b) disclose such Confidential Information only to the extent required by Applicable Law or judicial or administrative process. 10.5 Government-Required Disclosure. If a duly constituted government authority, court, Regulatory Authority or any public exchange on which the securities of such Party or its Affiliate is traded requires or orders that a receiving Party hereto disclose Confidential Information of the disclosing Party, such Party shall have the right to comply with the order, but (i) shall notify the disclosing Party as soon as possible so as to provide the disclosing Party an opportunity to apply to a court of record for relief from the order (if practicable under the circumstances), (ii) the receiving Party shall, at disclosing Party’s expense, assist the disclosing Party to apply to a court of record for relief from the order or other appropriate remedies, (iii) if the disclosing Party fails to obtain any protective order or other remedy, the receiving Party shall furnish only that portion of the Confidential Information that is legally required to be disclosed, and (iv) any Confidential Information so disclosed shall be treated as confidential for all purposes other than such legally compelled disclosure. 10.6 Publicity. Neither Party will refer to, display or use the other’s name, trademarks or trade names confusingly similar thereto, alone or in conjunction with any other words or names, in any manner or connection whatsoever, including in any publication, article, or any form of advertising or publicity, except with the prior written consent of the other Party which consent shall not be unreasonably withheld, conditioned or delayed. The Parties agree to issue a joint press release upon execution of this Agreement to be agreed to between the Parties. In cases where CLIENT will be required to use LONZA’s trademark or trade names on any labeling or packaging of the Product, CLIENT shall present a sample of such labeling and packaging to LONZA for its approval, such approval not to be unreasonably withheld, delayed or conditioned so long as CLIENT adheres to LONZA’s specifications and use requirements for the trademarks and/or trade names as to be defined and agreed upon in a separate trademark licensing agreement. 11. INTELLECTUAL PROPERTY 11.1 Ownership. 11.1.1 Background Intellectual Property. Except as expressly otherwise provided herein, neither Party will, as a result of this Agreement, acquire any right, title, or interest in any Background Intellectual Property of the other Party. 11.1.2 LONZA New IP. Notwithstanding Section 11.1.3, LONZA shall own all right, title and interest in “LONZA New IP”, which as used in this Agreement means Intellectual Property that LONZA or its Affiliates, or other contractors or agents of LONZA develops, conceives, invents, or first reduces to practice or makes in the course of performance under this Agreement that [***]. As used in this Section 11.1.2, [***]. CLIENT agrees to assign and hereby


 
28 assigns to LONZA, and undertakes to have its Affiliates and subcontractors assign to LONZA, all of CLIENT’s and its Affiliates right, title and interest in and to the LONZA New IP. 11.1.3 CLIENT New IP. Subject to Section 11.1.2, CLIENT shall own all right, title, and interest in and to any and all Intellectual Property that LONZA or its Affiliates develops, conceives, invents, first reduces to practice or makes, solely or jointly with CLIENT or others, that [***] (“CLIENT New IP”). LONZA agrees to assign and hereby assigns to CLIENT, and undertakes to have its Affiliates and subcontractors assign to CLIENT, all of LONZA’s and its Affiliates right, title and interest in and to the CLIENT New IP. 11.1.4 Disclosure and Documentation. LONZA agrees to promptly disclose to CLIENT in writing all LONZA New IP and CLIENT New IP. LONZA shall execute and shall cause its personnel as well as its Affiliates and its Affiliates’ personnel involved in the performance of this Agreement to execute, any documents reasonably required to confirm or perfect the CLIENT’s ownership of the CLIENT New IP and any documents required for CLIENT to apply for, maintain and enforce any patent or other right in such CLIENT New IP. 11.2 License Grant. During the Term of this Agreement, CLIENT hereby grants to LONZA a fully-paid, non-exclusive license under any and all CLIENT Intellectual Property that is necessary for LONZA to perform its obligations under this Agreement for the sole and limited purpose of LONZA’s performance of its obligations under this Agreement. The License set forth in this Section 11.2.1 does not include any right or license to perform services using CLIENT Intellectual Property on behalf of any Third Party, and no license is granted from CLIENT to use CLIENT Intellectual Property to manufacture or supply any product for any Third Party (or to sell or otherwise provide any such product to any Third Party), and LONZA agrees that it and its Affiliates shall not do so without the express prior written consent of CLIENT. 11.3 Incorporated Technologies. 11.3.1 Incorporated Technology. LONZA agrees [***]. If LONZA desires to incorporate any of the foregoing Intellectual Property in the Process or Product, or otherwise has reason to believe that doing so is necessary, then LONZA shall [***]. With respect to any LONZA Background Intellectual Property, LONZA New IP, LONZA (or its Affiliates) Confidential Information, in each case, that is incorporated into or is otherwise necessary or useful to manufacture, use or exploit any Product or the Process (each an “Incorporated Technology”) subject to the terms and conditions set forth herein, LONZA hereby grants to CLIENT and its Affiliates [***] under the Incorporated Technologies to [***]. With respect to [***], such license shall be subject to the applicable CMO License Royalty, if any pursuant to Section 11.3.2, and otherwise shall be royalty-free and fully-paid. 11.3.2 CMO License Royalty. If [***] then CLIENT shall pay to LONZA the applicable royalty (“CMO License Royalty”) on [***]. As used herein, the CMO License Royalty means [***]. 11.4 Further Assurances. Each Party agrees to take all necessary and proper acts, and will cause its employees, Affiliates, contractors, and consultants to take such necessary and proper acts, to effectuate the ownership provisions set forth in this Article 11.


 
29 11.5 Prosecution of Patents. 11.5.1 LONZA will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming LONZA New IP at LONZA’s expense. CLIENT will cooperate with LONZA to file, prosecute and maintain patent applications and patents claiming LONZA New IP. 11.5.2 CLIENT will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming CLIENT New IP at CLIENT’s expense. LONZA will cooperate with CLIENT to file, prosecute and maintain patent applications and patents claiming CLIENT New IP. 12. REPRESENTATIONS AND WARRANTIES 12.1 Mutual Representations and Warranties. Each Party represents and warrants to the other Party that: (a) it has the power and authority to enter into this Agreement and to perform its obligations hereunder and to grant to the other Party the rights granted to such other Party under this Agreement, (b) it has obtained all necessary corporate approvals to enter into and execute this Agreement, and (c) it is not presently a party to, nor will it enter into or assume during the Term of this Agreement, any contract or other obligation with a Third Party that would in any way limit the performance of its obligations under this Agreement. 12.2 By CLIENT. CLIENT hereby represents and warrants to LONZA that, [***], (i) the CLIENT Materials supplied under this Agreement will be free and clear of any security interest, lien, or other encumbrance; (ii) as of the A&R Effective Date, CLIENT is unaware of any circumstances that will likely make any CLIENT Materials unavailable on a timely basis and on commercially reasonable terms and conditions; (iii) it has the requisite Intellectual Property and legal rights to authorize the performance of LONZA’s obligations under this Agreement and [***]; provided, however, that CLIENT makes no representation or warranty with respect to any LONZA Background IP, LONZA New IP, [***]. Such representation and warranty will not apply to any production equipment supplied by LONZA. 12.3 By LONZA. LONZA hereby represents and warrants to CLIENT that, [***] and independent of the use of the Process, Master Production Record, Specifications, CLIENT Materials, CLIENT Confidential Information or CLIENT Background Intellectual Property: (i) it has the requisite Intellectual Property and legal rights in its equipment, Facilities, Materials, Background Intellectual Property, Third Party Intellectual Property and other Intellectual Property or materials provided or introduced by LONZA, to be able to perform its obligations under this Agreement without giving rise to a potential cause of action by a Third Party against CLIENT for infringement or another violation of Intellectual Property rights; provided, however, that LONZA makes no representation or warranty with respect to any CLIENT Background IP, CLIENT New IP, Third Party Intellectual Property or other Intellectual Property or materials provided or introduced by CLIENT, or any aspects of the Process developed by CLIENT (ii) as of the A&R Effective Date and for the duration of the Term, the Facility has the required support areas and systems to function as a commercial manufacturing facility for the Product in accordance with the terms of this Agreement; (iii) as of the A&R Effective Date, the Facility is solely owned by LONZA or any of its Affiliates; (iv) [***]; (v) LONZA shall perform all the Services hereunder


 
30 in a workman-like and professional manner in accordance with this Agreement (including the applicable Statement of Work and Quality Agreement) and all Applicable Laws and relevant industry standards; (vi) all Product supplied under this Agreement will be free and clear of any security interest, lien, or other encumbrance; (vii) [***]; (viii) the portions of the Facility in which manufacturing or supply of Products occurs or any Services under this Agreement are performed [***] are in full compliance with cGMP standards, as applicable, and (ix) neither LONZA nor any of its employees or permitted subcontractors performing or involved with its performance under this Agreement have been [***]. LONZA will promptly notify CLIENT in writing if [***]. LONZA shall at all times during the term of this Agreement maintain and conduct [***] and in any event as reasonably necessary or appropriate to fulfill its obligations hereunder and in each case [***]. 13. DISCLAIMERS; LIMITATION OF LIABILITY 13.1 Disclaimer of Warranties. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS AND GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, WITH RESPECT TO THE PRODUCT, MATERIALS, AND SERVICES PROVIDED UNDER THIS AGREEMENT, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE WITH RESPECT TO SUCH PRODUCT, MATERIALS, OR SERVICES. 13.2 Disclaimer of Consequential Damages. EXCEPT FOR LIABILITIES ARISING FROM [***], IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT OR SPECIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY THE OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY PUNITIVE OR EXEMPLARY DAMAGES SUFFERED OR INCURRED BY THE OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH THIS AGREEMENT. TO THE EXTENT THAT THIS CLAUSE CONFLICTS WITH ANY OTHER CLAUSE, THIS CLAUSE SHALL TAKE PRECEDENCE OVER SUCH CONFLICTING CLAUSE. IF APPLICABLE LAW PREVENTS ENFORCEMENT OF THIS CLAUSE, THEN THIS CLAUSE SHALL [***] AS IS ALLOWABLE UNDER APPLICABLE LAW. 13.3 Limitation of Liability. EXCEPT FOR [***], BOTH PARTIES HEREBY AGREE THAT TO THE FULLEST EXTENT PERMITTED BY LAW, LONZA’S LIABLITY TO CLIENT FOR ANY AND ALL INJURIES, CLAIMS, LOSSES, EXPENSES OR DAMAGES, WHATSOEVER, ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT FROM ANY CAUSE OR CAUSES, INCLUDING BUT NOT LIMITED TO, NEGLIGENCE, ERRORS, OMISSIONS OR STRICT LIABILITY, SHALL NOT EXCEED [***].


 
31 14. TERM AND TERMINATION 14.1 Term. Unless earlier terminated, the term of this Agreement will commence on the Effective Date and will continue until the [***] anniversary of the Initiation Date (the “Initial Term”); provided, however, that CLIENT may, at is option, extend the term of this Agreement for up to [***] successive [***] terms following expiration of the Initial Term (each an “Extended Term”) by providing written notice thereof to LONZA no later than [***] prior to expiration of the then-current Term. The Initial Term, together with any Extended Terms shall be collectively referred to herein as the “Term.” 14.2 Termination for Material Breach. In the event of any Material Breach of this Agreement, the non-breaching Party may terminate this Agreement in its entirety, upon [***] prior written notice to the other Party referencing this Section 14.2 and specifying in [***] detail the facts and circumstances constituting such Material Breach of this Agreement, if such breach is not cured within such [***] period; provided, however, that if such breach is not capable of being cured within such [***] (for clarity, except for a payment default) and the breaching Party [***] the cure of the Material Breach, then the cure period shall be extended to [***]. Such termination shall be effective upon expiration of such cure period. Notwithstanding Section 7.6, in the event of termination by LONZA pursuant to this Section 14.2, within [***] of such termination, CLIENT shall be required to pay the then-applicable True-Up Payment, if any. In the event that this Agreement is terminated in accordance with this Section 14.2 by CLIENT, the provisions of Section 14.6.2 shall apply. For purposes of this Section 14.2, a “Material Breach” means any breach, or series of related breaches, that materially and adversely affects the fundamental rights, obligations, or continuing activities of either Party under this Agreement, taken as a whole, including any intentional breach. 14.3 Termination without Cause. After the [***] anniversary of the Initiation Date, (i) CLIENT may terminate this Agreement in its entirety by providing written notice of termination no less than [***] in advance of the date of termination, and (ii) LONZA may terminate this Agreement in its entirety by providing written notice of termination no less than [***] in advance of the date of termination. [***]. CLIENT shall remain liable for any fees owed pursuant to any outstanding Statement of Work or Purchase Order during such [***]. In the event this Agreement is terminated in accordance with this Section 14.3 by CLIENT, CLIENT shall, at its election, (A) [***] or (B) [***]. In the event that this Agreement is terminated in accordance with this Section 14.3 by LONZA, the provisions of Section 14.6.2 shall apply. 14.4 Reserved. 14.5 Termination by Insolvency. Either Party may terminate this Agreement upon written notice to the other Party, upon (a) the dissolution, termination of existence, liquidation or business failure of the other Party; (b) the appointment of a custodian or receiver for the other Party who has not been terminated or dismissed within [***] of such appointment; (c) the institution by the other Party of any proceeding under national, federal or state bankruptcy, reorganization, receivership or other similar laws affecting the rights of creditors generally or the making by such Party of a composition or any assignment for the benefit of creditors under any national, federal or state bankruptcy, reorganization, receivership or other similar law affecting the rights of creditors generally, which proceeding is not dismissed within [***] of filing. All rights


 
32 and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code, licenses of rights of “intellectual property” as defined therein. 14.6 Effects of Expiration or Termination. 14.6.1 Accrued Rights. Upon expiration or termination of this Agreement in its entirety, this Agreement (including all applicable Statements of Work) shall, except as otherwise provided herein, be of no further force or effect and neither Party shall have any further liability under this Agreement. Expiration or termination of this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to such termination and shall not release any Party hereto from any obligation or liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such expiration or termination. Expiration or termination of this Agreement will not relieve a Party of obligations that are expressly indicated to survive the expiration or termination of this Agreement. Without limitation of the foregoing, in the event of termination hereunder, LONZA shall be compensated for (i) [***]; (ii) [***]; and (iii) [***]. In the case of termination by LONZA for CLIENT’s material breach, [***], and Cancellation Payment shall be calculated as of [***]. 14.6.2 Transfer for LONZA’s Breach or Termination without Cause. In the event of [***], LONZA shall execute a Technology Transfer to CLIENT, its Affiliate or a Third Party Manufacturer selected by CLIENT in its sole discretion, [***]. Without limiting the foregoing, LONZA will provide up to [***] for no longer than [***] to support such Technology Transfer in an efficient and timely manner. Notwithstanding the foregoing, in no event shall LONZA’s costs and expenses (excluding costs and expenses associated with LONZA’s personnel) with respect to such Technology Transfer exceed [***], provided that [***]. 14.6.3 Disposition of Remaining CLIENT Property and Confidential Information. Upon termination or expiration of this Agreement, LONZA will inform CLIENT in writing, [***], of all Remaining CLIENT Property and Media Waste (if any) and will store any Remaining CLIENT Property as set forth in Section 7.10 above. At CLIENT’s option, LONZA shall return or destroy or transfer to any Affiliate or Third Party designed by CLIENT, any CLIENT Confidential Information or CLIENT Materials of Media Waste (if any) (including all copies and embodiments thereof, with the exception of one (1) copy which LONZA may retain subject to the confidentiality obligations set forth herein to demonstrate LONZA’s compliance with the obligations set forth herein) in the possession or control of LONZA. Likewise, CLIENT will, at LONZA’s option, return or destroy any LONZA Confidential Information in the possession or control of CLIENT, except to the extent such LONZA Confidential Information is reasonably necessary for CLIENT or its Affiliates or designees to practice under any licenses, which survive termination or expiration of this Agreement, granted in this Agreement. Notwithstanding the foregoing provisions: (i) LONZA may retain and preserve, at its sole cost and expense, samples and standards of each Product following termination or expiration of this Agreement solely for use in determining LONZA’s rights and obligations hereunder; and (ii) each Party may retain a single copy of the other Party’s Confidential Information for documentation purposes only and copies remaining of such Parties standard computer back-up devices, in each case, which shall remain subject to the obligations of nonuse and confidentiality set forth in this Agreement return or destroy any LONZA Confidential Information in the possession or control of CLIENT, [***].


 
33 Notwithstanding the foregoing provisions: (i) LONZA may retain and preserve, [***], samples and standards of each Product following termination or expiration of this Agreement solely for use in determining LONZA’s rights and obligations hereunder; and (ii) each Party may retain a single copy of the other Party’s Confidential Information for documentation purposes only and copies remaining of such Parties standard computer back-up devices, in each case, which shall remain subject to the obligations of nonuse and confidentiality set forth in this Agreement. 14.6.4 Survival. Sections 1, 2.3 (last three sentences only), 2.8, 2.9 4.1, 5.3 (last three sentences only), 5.10, 5.11.5, 5.11.6, 8.6, 9.8 (for the period set forth therein), 10, 11, 13, 14.5 (last sentence only), 14.6, 15.1 to 15.3 (inclusive), 15.4 (for the period set for therein), 16.1 (for the period set forth therein), 16.2, 16.4 to 16.16 (inclusive) of this Agreement, together with any appendices referenced therein, will survive any expiration or termination of this Agreement. 15. INDEMNIFICATION 15.1 Indemnification of CLIENT. LONZA will indemnify CLIENT, its Affiliates, and their respective directors, officers, employees and agents, and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) in connection with any and all liability suits, investigations, claims or demands (collectively, “Losses”) to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of: (a) [***], (b) [***], or (iii) [***], or (iv) [***], or (c) [***]. 15.2 Indemnification of LONZA. CLIENT will indemnify LONZA and its Affiliates, and their respective directors, officers, employees and agents (the “LONZA Parties”), and defend and hold each of them harmless, from and against any and all Losses to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of: (a) [***], (b) [***], (c) [***], or (d) [***]. 15.3 Indemnification Procedure. 15.3.1 An “Indemnitor” means the indemnifying Party. An “lndemnitee” means the indemnified Party, its Affiliates, and their respective directors, officers, employees and agents. 15.3.2 An Indemnitee which intends to claim indemnification under Section 15.1 or Section 15.2 hereof shall promptly notify the Indemnitor in writing of any claim, lawsuit or other action in respect of which the Indemnitee, its Affiliates, or any of their respective directors, officers, employees and agents intend to claim such indemnification. The Indemnitee shall permit, and shall cause its Affiliates and their respective directors, officers, employees and agents to permit, the Indemnitor, at its discretion, to settle any such claim, lawsuit or other action and agrees to the complete control of such defense or settlement by the Indemnitor; provided, however, that in order for the Indemnitor to exercise such rights, such settlement shall not adversely affect the Indemnitee’s rights under this Agreement or impose any obligations on the Indemnitee in addition to those set forth herein. No such claim, lawsuit or other action shall be settled without the prior written consent of the Indemnitor and the Indemnitor shall not be responsible for any legal fees or other costs incurred other than as provided herein. The Indemnitee, its Affiliates and their respective directors, officers, employees and agents shall cooperate fully with the Indemnitor and


 
34 its legal representatives in the investigation and defense of any claim, lawsuit or other action covered by this indemnification, all at the reasonable expense of the Indemnitor. The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and expense. 15.4 Insurance. Each Party will maintain, at all times during the Term and for [***] thereafter, (i) a products liability insurance policy for [***] per occurrence and in the aggregate during any one policy period, and (ii) general liability insurance for ***] per occurrence (collectively, the “Insurance Policy”). Each Party will maintain the Insurance Policy with an insurance company having a minimum AM Best rating of A. Each Party will provide the other with at least [***] written notice prior to termination of such Insurance Policy. 16. MISCELLANEOUS 16.1 Non-Solicitation. During the term of this Agreement and for [***] thereafter, each of the Parties agrees not to [***]; provided, however, that neither Party shall be in violation of this Section 16.1 as a result of making a general solicitation for employees or independent contractors. For the avoidance of doubt, the publication of an advertisement shall not constitute solicitation or inducement. 16.2 Independent Contractors. Each of the Parties is an independent contractor and nothing herein contained shall be deemed to constitute the relationship of partners, joint venturers, nor of principal and agent between the Parties. Neither Party shall at any time enter into, incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever. 16.3 Force Majeure. Neither Party shall be in breach of this Agreement if there is any failure of performance under this Agreement (except for payment of any amounts due under this Agreement; [***]) occasioned by any reason beyond the control and without the fault or negligence of the Party affected thereby, including, without limitation, [***] (a “Force Majeure Event”). Such excuse shall continue as long as the Force Majeure Event continues. Upon cessation of such Force Majeure Event, the affected Party shall resume performance under this Agreement as soon as soon as reasonably possible for the Party to do so. Each Party agrees to give the other Party prompt written notice of the occurrence of any Force Majeure Event, the nature thereof, and the extent to which the affected Party will be unable to fully perform its obligations under this Agreement. Each Party further agrees to use Reasonable Commercial Efforts to correct the Force Majeure Event as quickly as practicable ([***]) and to give the other Party prompt written notice when it is again fully able to perform such obligations. [***]. 16.4 Notices. Any notice required or permitted to be given under this Agreement by any Party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by a nationally-recognized courier service guaranteeing [***] delivery, charges prepaid, or (d) delivered by facsimile (with documented evidence of transmission), to the addresses or facsimile numbers of the other Party set forth below, or at such other addresses as may from time to time be furnished by similar notice by any Party. The effective date of any notice under this Agreement shall be the date of receipt by the receiving Party.


 
35 If to LONZA: Lonza Biosciences Singapore Pte. Ltd. [***] [***] [***] With a copy to: [***] [***] [***] [***] [***] If to CLIENT: Mesoblast International Sarl c/o Mesoblast Limited Attn: Group General Counsel Level 38, 55 Collins Street Melbourne, Victoria 3000 Australia Fax: 61 3 9639 6030 With a copy to: Wilson Sonsini Attn: Ian Edvalson 650 Page Mill Road Palo Alto, CA 94304 USA Either Party may change its address for notice by giving notice thereof in the manner set forth in this Section 16.4. 16.5 Entire Agreement; Amendments. This Agreement, including the Appendix and Exhibits attached hereto and referenced herein, constitutes the full understanding of the Parties and a complete and exclusive statement of the terms of their agreement with respect to the specific subject matter hereof and supersedes all prior agreements and understandings, oral and written, among the Parties with respect to the subject matter hereof. No terms, conditions, understandings or agreements purporting to amend, modify or vary the terms of this Agreement (including any Appendix hereto) shall be binding unless hereafter made in a written instrument referencing this Agreement and signed by each of the Parties. 16.6 Governing Law. The construction, validity and performance of the Agreement shall be governed by and construed in accordance with the internal laws of [***], without giving effect to its conflicts of laws provisions. Subject to Section 16.14, the Parties consent to the exclusive jurisdiction of the state and federal court located in the [***] for enforcement of any arbitration award and application for interim relief pending resolution of arbitration.


 
36 16.7 Counterparts. This Agreement and any amendment hereto may be executed in any number of counterparts, each of which shall for all purposes be deemed an original and all of which shall constitute the same instrument. This Agreement shall be effective upon full execution by facsimile, portable document format (.pdf) or original, and a facsimile or a .pdf signature shall be deemed to be and shall be as effective as an original signature. 16.8 Severability. If any part of this Agreement shall be found to be invalid or unenforceable under applicable law in any jurisdiction, such part shall be ineffective only to the extent of such invalidity or unenforceability in such jurisdiction, without in any way affecting the remaining parts of this Agreement in that jurisdiction or the validity or enforceability of the Agreement as a whole in any other jurisdiction. In addition, the part that is ineffective shall be reformed in a mutually agreeable manner so as to as nearly approximate the intent of the Parties as possible. 16.9 Titles and Subtitles. All headings, titles and subtitles used in this Agreement (including any Appendix hereto) are for convenience only and are not to be considered in construing or interpreting any term or provision of this Agreement (or any Appendix hereto). 16.10 Exhibits. All definitions, exhibits and the appendix referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference. 16.11 Interpretation. Unless specified to the contrary, references to Articles, Sections, Exhibits or Appendix mean the particular Articles, Sections, Exhibits or Appendix to this Agreement and references to this Agreement include all Exhibits hereto. Unless the context clearly requires otherwise, whenever used in this Agreement: (a) the words “include’’. or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation” whether or not such additional words are written, (b) the word “or” shall have its inclusive meaning of “and/or” except when paired as “either/or”, (c) the word “day” or “quarter” or “year” means a calendar day or calendar quarter or calendar year unless otherwise specified, (d) the word “notice” shall require notice in writing (whether or not specifically stated) and shall include notices, consents, approvals, and other communications contemplated under this Agreement, (e) the words “hereof,” “herein,” “hereunder,” “hereby” and derivative or similar words refer to this Agreement (including the Exhibits hereto), (f) provisions that require a Party, the Parties or a committee hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter or otherwise, (g) words of any gender include the other gender, (h) words using the singular or plural number also include the plural or singular number, respectively, (i) references to any specific law, article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement thereof, and dollars (and amounts indicated with the symbol”$”) mean United States dollars unless expressly stated otherwise. Each accounting term used herein that is not specifically defined herein shall have the meaning given to it under U.S. Generally Accepted Accounting Principles, or other generally accepted cost accounting principles in the applicable territory, but only to the extent consistent with its usage and the other definitions in this Agreement. 16.12 Assignment. This Agreement shall be binding upon the successors and assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of its successors and assigns. Neither Party shall assign its interest under this Agreement without the


 
37 prior written consent of the other Party, such consent not to be unreasonably withheld; provided, however, either Party shall be entitled without the prior written consent of the other Party (but with written notice to the other Party) to assign this Agreement to an Affiliate of such Party so long as such Party agrees to guaranty any obligations of its Affiliates under this Agreement or to any entity to which a Party transfers all or substantially all of its assets or capital stock relating to the activities contemplated under this Agreement, whether through purchase, merger, consolidation or otherwise; provided, further, however, if such assignee of CLIENT [***], then [***]. Any permitted assignment of this Agreement by either Party will be conditioned upon that Party’s permitted assignee agreeing in writing to comply with all the terms and conditions contained in this Agreement. Any purported assignment in violation of the foregoing shall be void. No assignment shall relieve any Party of responsibility for the performance of any obligation that accrued prior to the effective date of such assignment. 16.13 Waiver. The failure of any Party at any time or times to require performance of any provision of this Agreement (including any Appendix or Exhibit hereto) will in no manner affect its rights at a later time to enforce the same. No waiver by any Party of any term, provision or condition contained in this Agreement (including any Appendix or Exhibit hereto), whether by conduct or otherwise, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or of any other term, provision or condition of this Agreement (including any Appendix or Exhibit hereto). 16.14 Dispute Resolution. 16.14.1General. If the Parties are unable to resolve a dispute (other than a Warranty Dispute or an IP Dispute, any, a “Dispute”), despite its good faith efforts, either Party may refer the dispute to the Senior Executives of each Party’s respective business unit (or other designee). In the event that no agreement is reached by the Senior Executives with respect to such dispute within [***] after its referral to them, either Party may refer such matter (other than IP Disputes, as defined hereinafter) to arbitration pursuant to this Section 16.14.1. Except with respect to an IP Dispute (as defined in Section 16.14.2), the Parties agree that any dispute or controversy arising under this Agreement, or regarding the validity, enforceability, construction, performance, alleged breach or enforcement of this Agreement, shall be finally settled by [***] under this Section 16.14.1, [***], The place of the [***] shall be in [***]. The Parties agree that the decision shall be the sole, exclusive and binding remedy between them regarding determination of the matters [***]. The costs of such [***] shall be [***], and each Party shall bear its own expenses and attorney’s fees incurred in connection with [***]. The Parties shall use good faith efforts to complete [***] under this Section 16.14.1, within [***] following the initiation of such [***], and the [***] within such [***] period. For clarity, this Section 16.14.1 shall be the exclusive dispute resolution mechanism for Disputes. 16.15 IP Disputes. Any dispute, controversy or claim between the Parties relating to the ownership, scope, validity, enforceability or infringement of any Intellectual Property or the scope of any license hereunder to Intellectual Property (any, an “IP Dispute”) shall be [***]. 16.16 No Presumption against Drafter. For purposes of this Agreement, both Parties hereby waive any rule of construction that requires that ambiguities in this Agreement (including any Appendix or Exhibit hereto) be construed against the drafter.


 
38 16.17 Obligation to Mitigate. Each Party shall use Reasonable Commercial Efforts to mitigate any harm or penalty to the other Party arising out of matters hereunder, including in the case of LONZA any Cancellation Payment payable by CLIENT hereunder, including with respect to [***], in each case (a) and (b) for any period during which any Cancellation Payment is due (any, “Mitigation Proceeds”). [***]. [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]


 
IN WITNESS WHEREOF, each Party executed this Agreement effective as of the A&R Effective Date. Lonza Biosciences Singapore Pte. Ltd. By: Name: Title: Mesoblast International Sàrl By: Name: Title: Appendix and Exhibit List: • Exhibit 2.9.5: Active SOWs and CCs • Exhibit 5.3: CLIENT Production Materials • Exhibit 5.5: Safety Stock Requirements • Exhibit 5.6: Shipping Documentation • Exhibit 7.4: Form P.O. • Exhibit 8.7: Facility Renovations • Exhibit 9.2: Product Pricing