Common use of PRODUCT AND PROCESS VALIDATION Clause in Contracts

PRODUCT AND PROCESS VALIDATION. 12.1 Process Validation– XERIS is responsible for ensuring the PYRAMID production process is validated for product. The validation should ensure the process is capable of effectively and reproducibly achieving the product acceptance specifications and quality attributes. PYRAMID shall provide adequate resources to execute process validations as per mutually approved protocols. XERIS is responsible for development and validation of the manufacturing process including processing hold times, formulation and process parameters, and filter validations. The activities may be contracted to PYRAMID, and if so, terms shall be outlined in the Master Services Agreement or in the Project Plan. 12.1.1 PYRAMID will work in conjunction with XERIS to support their process validation or related studies. PYRAMID may perform these studies on behalf of XERIS. XERIS holds final responsibility for the study design and execution, results, conclusions, and approval. 12.1.2 PYRAMID will provide XERIS with appropriate quality system, material, process, or product data to support XERIS’ continued process verification activities. PYRAMID may also collaborate with XERIS on process assessments as a means of evaluating process variability. PYRAMID performs routine reviews of quality system, manufacturing, calibration, and maintenance data as part of the [***] management review. Where appropriate, those data may be made available to XERIS for incorporation in to their process verification activities. 12.2 Cleaning Verification– PYRAMID is responsible for ensuring adequate cleaning of product contact parts used in the Production of Product is carried out between Batches of different product to prevent contamination. 12.3 Sterilization and Depyrogenation Validation – PYRAMID is responsible for ensuring sterilization processes are validated and adequate sterilization and Document No: QAA-XERIS Revision: 03 Revision Date: 11/16/20 Replaces: 02 Page: 21 of 40 depyrogenation is carried out on the Components and appropriate equipment prior to the Production of each Batch of Products. 12.4 Equipment, Computerized Systems, Facility, and Utilities Qualification – PYRAMID is responsible for ensuring any equipment, computer, Facility, utility and support systems used to produce product are qualified according to applicable regulatory requirements.

PRODUCT AND PROCESS VALIDATION. 12.1 Process Validation– Validation- XERIS is responsible for ensuring the PYRAMID production Production process is validated for productvalidated. The validation should ensure the process is capable of effectively and reproducibly achieving the product Product acceptance specifications and quality attributes. PYRAMID shall provide adequate resources to execute process validations as per mutually approved protocols. XERIS is responsible for development and validation of the manufacturing process including processing hold times, formulation and process parameters, and filter validations. The activities may be contracted to PYRAMID, and if so, terms shall be outlined in the Master Services Agreement or in the Project Plan. 12.1.1 PYRAMID will work in conjunction with XERIS to support their process validation or related studies. PYRAMID may perform these studies on behalf of XERIS. XERIS holds final responsibility for the study design and execution, results, and conclusions, and approval. 12.1.2 PYRAMID will provide XERIS with appropriate quality system, material, process, or product data to support XERISXeris’ continued process verification activities. PYRAMID may also collaborate with XERIS on process assessments as a means of evaluating process variability. PYRAMID performs routine reviews of quality system, manufacturing, calibration, and maintenance data as part of the [***] management review. Where appropriate, those data may be made available to XERIS for incorporation in to into their process verification activities. 12.2 Cleaning Verification– /Validation - PYRAMID is responsible for ensuring adequate cleaning of product Product contact parts used in the Production of Product is carried out between Batches of different product to prevent contamination.. Document No: Revision: Revision Date: Replaces: Page: QA-Xeris 00 11/10/16 NA Page 26 of 52 12.3 Sterilization and Depyrogenation Validation – - PYRAMID is responsible for ensuring sterilization processes are validated and adequate sterilization and Document No: QAA-XERIS Revision: 03 Revision Date: 11/16/20 Replaces: 02 Page: 21 of 40 depyrogenation is carried out on the Components and appropriate equipment prior to the Production of each Batch of Products. 12.4 Equipment, Computerized Systems, Facility, and Utilities Qualification – - PYRAMID is responsible for ensuring any equipment, computer, Facility, utility and support systems used to produce product for the Production of Product are qualified according to applicable regulatory requirements. 12.5 Laboratory Qualification - PYRAMID is responsible for ensuring all laboratories are in compliance with cGMPs and are qualified in all of the methodology associated with the Product. If Product specific analytical work is performed at PYRAMID, then XERIS will provide any relevant analytical documentation to assist in the methods transfer or methods validation. PYRAMID is responsible for third party laboratory qualification unless such laboratory is specified by XERIS. PYRAMID may be contracted to qualify third party laboratory at Xeris’ expense. 12.6 Shipping Qualification - XERIS is responsible for qualifying the shipping containers and process used for Product. If agreed, this activity may be contracted to PYRAMID. XERIS shall ensure all DOT requirements are met by shipping configurations.