Common use of Product Design Clause in Contracts

Product Design. 2.1. CM will manufacture the Product in accordance to the specifications provided by MFR (see Addendum C). MFR will maintain the Design History File and all associated documents (input, output, design FMEA, verification, and validation). Copies of relevant Design History File documentation will be provided to CM upon project commencement. The original Design History File will be maintained by MFR. 2.2. MFR shall inspect samples from each pilot lot in accordance with the incoming inspection criteria specified in Addendum C and provide inspection report to CM within 5 business days after receipt. 2.3. The CM is not allowed to make any modification to the Product that would cause it to be non‑conformant to the specifications or design, including but not limited to modifications that affect external appearance, functionality, regulatory approbation or performance, changes in components, materials, sub‑suppliers, engineering or production process, or manufacturing location without MFR’s written consent. MFR’s written consent to changes may include effective date and or implementation timeline. 2.4. CM will obtain MFR’s written approval on all proposed design changes. [***] 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.

Product Design. 2.1. CM will manufacture the Product in accordance to the specifications provided by MFR (see Addendum C). MFR will maintain the Design History File and all associated documents (input, output, design FMEA, verification, and validation). Copies of relevant Design History File documentation will be provided to CM upon project commencement. The original Design History File will be maintained by MFR. 2.2. MFR shall inspect samples from each pilot lot in accordance with the incoming inspection criteria specified in Addendum C and provide inspection report to CM within 5 business days after receipt. 2.3. The CM is not allowed to make any modification to the Product that would cause it to be non‑conformant to the specifications or design, including but not limited to modifications that affect external appearance, functionality, regulatory approbation or performance, changes in components, materials, sub‑suppliers, engineering or production process, or manufacturing location without MFR’s written consent. MFR’s written consent to changes may include effective date and or implementation timeline. 2.4. CM will obtain MFR’s written approval on all proposed design changes. [***] 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.