Common use of Program Performance Clause in Contracts

Program Performance. a) 3SBio shall provide the Facilities, Materials, supplies, staff and all other resources necessary to perform and complete the Program, as it may be modified as provided herein, and in accordance with the Scope and the terms of this Agreement. In the event of any conflict between the terms and provisions of this document and the Scope, the terms of the Agreement will control. b) Other than with respect to those portions of the Program that are performed at the facilities of subcontractors that have been pre-approved by Selecta in accordance with Section 5, 3SBio shall perform the Program at the Facilities, and shall hold at the Facility (where the warehouse is located) all Materials, Program-Dedicated Equipment, Filling Components, Process Consumables and Raw Materials for use in the Program and all other items used in the manufacturing of the Drug Product. 3SBio shall maintain, at its own expense, the Facilities in a state of operating efficiency consistent in order to perform duly under this Agreement and in compliance with the Specifications and Applicable Laws, provided that 3SBio shall not change the location of the Facilities without the prior written consent of Selecta, which consent shall not be unreasonably withheld. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. c) 3SBio will appoint a 3SBio representative (the “Program Manager”) to be responsible for the coordination of performance of the Program by 3SBio. The Program Manager will coordinate performance of the Program with a representative designated by Selecta (the “Selecta Representative”). Unless otherwise agreed in the Scope, or mutually agreed to by the Parties in writing, all communications between 3SBio and Selecta regarding the conduct of the Program pursuant to the Scope shall be addressed to or routed through the Program Manager and Selecta Representative. 3SBio may, at its option, substitute the Program Manager during the course of the Program and Selecta may, at its option, substitute Selecta Representative during the course of the Program, in each case upon written notice to the other Party. d) Promptly following the Effective Date, the Parties will agree on a detailed document specifying the quality and regulatory procedures and responsibilities of the Parties with respect to the manufacture of Drug Substance and Drug Product (the “Quality Agreement”). The Parties agree that if Selecta’s quality audit as performed prior to entering into this Agreement (the “Quality Audit”) discloses any issues that need to be corrected prior to the manufacture of the first cGMP Batch hereunder, then 3SBio will use commercially reasonable efforts to take appropriate corrective action prior to the initiation of the manufacture of such cGMP Batch. e) 3SBio shall use commercially reasonable efforts to meet and comply with the Purchase Orders, subject to the terms and conditions of this Agreement. 3SBio shall provide Selecta with as much advance notice as practicable if 3SBio determines that any Services or any portions of the Program will be delayed or eliminated for any reason. If 3SBio falls behind the agreed Production Plan or if any delivery of Drug Substance or Drug Product was out of Specifications, a JSC meeting will be called within [***] days of such determination. During such JSC meeting, 3SBio shall submit a remedy plan to Selecta specifying the reasons for, as well as activities and timelines to resolve, the issue(s), and shall immediately implement such remedy plan. In addition, if a Purchase Order has not been fulfilled within [***] month after its original due date in accordance with the Production Plan, 3SBio shall allocate Pegsiticase inventories and future production runs between Selecta and its other customers to expedite delivery until the Purchase Order has been completed in full, provided, however that such allocation to Selecta shall not exceed [***]% of Protein inventories and future production runs.

Program Performance. (a) 3SBio Discovery and Laureate are entering into a manufacturing and process development relationship with the purpose of manufacturing clinical and commercial supplies of Drug Product. Laureate shall use its commercially reasonable efforts to provide the Facilities, MaterialsFacility, supplies, staff and all other resources necessary to perform and complete the ProgramProgram as provided in the Scope, as it may be modified as provided herein, and in accordance with the Scope terms of this Agreement. Discovery shall use its commercially reasonable efforts to provide the Drug Substance, Product Dedicated Equipment, Other Active Ingredient supplies, staff and other resources necessary to complete the Program as provided in the Scope, as it may be modified as provided herein, in accordance with the terms of this Agreement. In the event of any conflict between the terms and provisions conditions of this document Agreement and the Scope, the terms of the this Agreement will shall control. (b) Other than with respect to those portions of the Program that are performed at the facilities of subcontractors that have been pre-approved by Selecta in accordance with Section 5, 3SBio Laureate shall perform the Program at the Facilities, and shall hold at the Facility (where the warehouse is located) all Materials, Program-Dedicated Equipment, Filling Components, Process Consumables and Raw Materials for use in the Program and all other items used in the manufacturing of the Drug Product. 3SBio shall maintain, at its own expense, the Facilities in a state of operating efficiency consistent in order to perform duly under this Agreement and in compliance with the Specifications and Applicable Laws, provided that 3SBio shall not change the location of the Facilities without the prior written consent of Selecta, which consent shall not be unreasonably withheld. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. c) 3SBio will appoint a 3SBio Laureate representative who shall be an employee of Laureate or its Affiliates (the “"Program Manager”) "), to be responsible for the coordination of performance completion of the Program by 3SBioLaureate. The Program Manager will coordinate performance of the Program with a representative designated by Selecta Discovery (the “Selecta "Discovery Representative”"), which representative shall have responsibility over all matters relating to the performance of the Program on behalf of Discovery. Unless otherwise agreed in the Scope, or mutually agreed to by the Parties in writing, all communications between 3SBio Laureate and Selecta Discovery regarding the conduct of the Program pursuant to the Scope shall be addressed to or routed through the Program Manager and Selecta the Discovery Representative. 3SBio Laureate may, at its option, substitute the Program Manager during the course of the Program and Selecta Program. Discovery may, at its option, substitute Selecta the Discovery Representative during the course of the Program; provided, in however that each case upon written notice Party hereby agrees to commit to the other PartyProgram appropriate personnel (including, those with reasonably sufficient expertise in technical development, manufacturing, operations, quality control, quality assurance and regulatory affairs.) TECHNOLOGY TRANSFER AND MANUFACTURING AGREEMENT d(c) Promptly As promptly as practicable following the Effective Date, the Parties will agree on execute a detailed document ("Quality Agreement") specifying the quality and regulatory procedures and responsibilities of the Parties hereunder with respect to the manufacture of Drug Substance and Drug Product (the “Quality Agreement”). The Parties agree that if Selecta’s quality audit as performed prior to entering into this Agreement (the “Quality Audit”) discloses any issues that need to be corrected prior to the manufacture of the first cGMP Batch hereunder, then 3SBio will use commercially reasonable efforts to take appropriate corrective action prior to the initiation of the manufacture of such cGMP BatchProduct. e) 3SBio shall use commercially reasonable efforts to meet and comply with the Purchase Orders, subject to the terms and conditions of this Agreement. 3SBio shall provide Selecta with as much advance notice as practicable if 3SBio determines that any Services or any portions of the Program will be delayed or eliminated for any reason. If 3SBio falls behind the agreed Production Plan or if any delivery of Drug Substance or Drug Product was out of Specifications, a JSC meeting will be called within [***] days of such determination. During such JSC meeting, 3SBio shall submit a remedy plan to Selecta specifying the reasons for, as well as activities and timelines to resolve, the issue(s), and shall immediately implement such remedy plan. In addition, if a Purchase Order has not been fulfilled within [***] month after its original due date in accordance with the Production Plan, 3SBio shall allocate Pegsiticase inventories and future production runs between Selecta and its other customers to expedite delivery until the Purchase Order has been completed in full, provided, however that such allocation to Selecta shall not exceed [***]% of Protein inventories and future production runs.

Program Performance. (a) 3SBio Laureate shall use its commercially reasonable efforts to perform the Services and to provide the Facilities, MaterialsFacility, supplies, and staff and all other resources necessary to perform and complete the ProgramProgram as provided in the Scope, as it may be modified as provided herein, and in accordance with the Scope and the terms of this Agreement. In the event of any conflict between the terms and provisions set forth in the body of this document Agreement and the terms set forth in the Scope, the terms contained in the body of the this Agreement will shall control. (b) Other than with respect to those portions of the Program that are performed at the facilities of subcontractors that have been pre-approved by Selecta in accordance with Section 5, 3SBio shall perform the Program at the Facilities, and shall hold at the Facility (where the warehouse is located) all Materials, Program-Dedicated Equipment, Filling Components, Process Consumables and Raw Materials for use in the Program and all other items used in the manufacturing of the Drug Product. 3SBio shall maintain, at its own expense, the Facilities in a state of operating efficiency consistent in order to perform duly under this Agreement and in compliance with the Specifications and Applicable Laws, provided that 3SBio shall not change the location of the Facilities without the prior written consent of Selecta, which consent shall not be unreasonably withheld. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. c) 3SBio Laureate will appoint a 3SBio Laureate representative (the “"Program Manager”") to be responsible for the coordination of performance completion of the Program by 3SBioLaureate. The Program Manager will coordinate performance of the Program with a representative designated by Selecta Customer (the “Selecta "Customer Representative”"), which representative shall have responsibility over all matters relating to performance of the Program on behalf of Customer. Unless otherwise agreed in the Scope, Scope or mutually agreed to by the Parties in writing, all communications between 3SBio Laureate and Selecta the Customer regarding the conduct of the Program pursuant to the Scope shall be addressed to or routed through the Program Manager and Selecta Customer Representative. 3SBio Laureate may, at its option, substitute the Program Manager during the course of the Program and Selecta Customer may, at its option, substitute Selecta the Customer Representative during the course of the Program, in each either case upon prior written notice to the other Partyparty. d(c) Promptly following the Effective Date, the Parties The parties will agree on prepare a detailed document ("Quality Agreement") specifying the quality and regulatory procedures and responsibilities of the Parties parties hereunder with respect to the manufacture of Drug Substance Bulk Intermediate. (d) Laureate shall perform all Services at the Facility and Drug Product retain at the Facility all Equipment, Process Consumables, excipients, packaging components and other items used in the manufacturing of Bulk Intermediate. Laureate may not change the location of the Facility without the prior written consent of Customer, which consent shall not be unreasonably withheld, delayed or conditioned. (the “Quality Agreement”). The Parties agree that if Selecta’s quality audit as performed prior e) Subject to entering into Section 4(c) of this Agreement (with respect to Product-Dedicated Equipment, Laureate shall supply, at its own expense, all Equipment required for the “Quality Audit”) discloses any issues that need to be corrected prior to purpose of performing the manufacture Services and/or manufacturing the Bulk Intermediate and certain Equipment used for the holding and/or quality control testing of the first cGMP Batch hereunderBulk Intermediate or Process Consumables. (f) Laureate shall maintain, then 3SBio will use commercially reasonable efforts to take appropriate corrective action prior to at its own expense, the initiation Facility and the Equipment, in a state of repair and operating efficiency consistent with the requirements of the manufacture of such cGMP BatchSpecifications, Good Manufacturing Practices and other applicable regulatory requirements. e(g) 3SBio Laureate may not change the Process in any respect without the prior written consent of Customer. Laureate shall use commercially reasonable efforts to meet and comply with the Purchase Orders, subject to the terms and conditions of this Agreement. 3SBio shall provide Selecta with as much advance notice as practicable if 3SBio determines that any Services or any portions be responsible for performing all validation testing of the Program will be delayed or eliminated Facility and for any reason. If 3SBio falls behind validating all production, cleaning and packaging processes employed in the agreed Production Plan or if any delivery of Drug Substance or Drug Product was out of SpecificationsProcess, a JSC meeting will be called within [***] days of such determination. During such JSC meeting, 3SBio shall submit a remedy plan to Selecta specifying the reasons for, as well as activities and timelines to resolve, the issue(s), and shall immediately implement such remedy plan. In addition, if a Purchase Order has not been fulfilled within [***] month after its original due date in accordance with the Production Plan, 3SBio shall allocate Pegsiticase inventories Good Manufacturing Practices and future production runs between Selecta and its other customers to expedite delivery until the Purchase Order has been completed in full, provided, however that such allocation to Selecta shall not exceed [***]% of Protein inventories and future production runsapplicable regulatory requirements.