Common use of Change Policy Clause in Contracts

Change Policy. 11.1 All changes to approved documents will be managed via PYRAMID’S change control or planned deviation processes. 11.2 All proposed changes go through a technical, regulatory, and cGMP impact assessment by the PYRAMID expert groups per PYRAMID change control procedure. The scope of this change process potentially impacting the Product (for Phase III, registration, or commercial purposes) includes but is not limited to Raw Materials, Process Consumables, Components, packaging materials, labeling, Production process, XERIS specific validated equipment, Facilities, utilities or computer systems, Product Specifications, and Test Methods. 11.3 The Product-specific controlled documents for Phase III, registration, or commercial purposes such as Batch Records, Product Specifications, and Product related Standard Operating Procedures or changes that may affect Xeris’ regulatory submissions will also go through Xeris’ review for regulatory impact, implementation requirements, and Xeris’ approval. Changes must have appropriate documentation to justify the rationale behind the change. Document No: Revision: Revision Date: Replaces: Page: QA-Xeris 00 11/10/16 NA Page 25 of 52 11.4 The Parties will assess changes within [***] and those changes marked urgent the Parties will use commercially reasonable efforts to assess within [***]. 11.5 Each Party agrees to notify the other of changes in key project personnel to ensure the effectiveness of arrangements and assure the quality of the Product. 11.6 XERIS will notify PYRAMID in writing who is authorized to make and approve changes on their behalf.

Change Policy. 11.1 All changes to approved documents will be managed via PYRAMID’S ’s change control or planned deviation processes. 11.2 All proposed changes go through a technical, regulatory, and cGMP impact assessment by the PYRAMID expert groups per PYRAMID change control procedure. The scope of this change process potentially impacting the Product (for Phase III, registration, or commercial purposes) includes but is not limited to Raw Materials, Process Consumables, ComponentsComponents and or their suppliers, packaging materials, labeling, Production process, equipment, XERIS specific validated Document No: QAA-XERIS Revision: 03 Revision Date: 11/16/20 Replaces: 02 Page: 20 of 40 equipment, Facilities, utilities or computer systems, Product Specifications, and Test Methodstest methods. 11.3 The Product-specific controlled documents for Phase III, registration, or commercial purposes such as Batch Records, Product Specifications, and Product related Standard Operating Procedures or changes that may affect XerisXERIS’ regulatory submissions will also go through XerisXERIS’ review for regulatory impact, implementation requirements, and XerisXERIS’ approval. Changes must have appropriate documentation to justify the rationale behind the change. Document No: Revision: Revision Date: Replaces: Page: QA-Xeris 00 11/10/16 NA Page 25 of 52. 11.4 The Parties will assess changes within [***] and for those changes marked urgent urgent, the Parties will use commercially reasonable efforts to assess within [***]. 11.5 Each Party agrees to notify the other of changes in key project personnel to ensure the effectiveness of arrangements and assure the quality of the Product. 11.6 XERIS will notify PYRAMID in writing who is authorized to make and approve changes on their behalf.