General: As a supplier to SINTX Technologies Inc. (“SINTX”), you become a key contributor to the products and services that we deliver to our customers. It is expected SINTX suppliers have an implemented and auditable Quality Management System. We value the conformance of your products and services to our specifications and requirements, your contribution to our product’s safety, and your ethical business practices. SINTX purchase orders document, or make reference to, the acceptance criteria of those orders.
SINTX’s purchase order acceptance criteria will communicate requirements for:

a. the processes, products, and services to be provided, including the identification of relevant technical data (e.g., specifications, drawings, process requirements, work instructions);
b. the approval of 1) products and services. 2.) Methods, processes, and equipment. 3.) The release of products and services.
c. competence, including any required qualification of persons;
d. the external provider’s interactions with the organization;
e. design and development control;
f. special requirements, critical items, or key characteristics;
g. test, inspection, and verification (including production process verification);
h. the use of statistical techniques for product acceptance and related instructions.

It is understood that your organization agrees to meet the following AS9100 requirements whenever a SINTX purchase order specifies that the order is subject to AS9100.

Scope: These terms and conditions apply to all external suppliers and sub-tier suppliers which furnish products, processes, or services to be incorporated into SINTX’s contractually deliverable aerospace products:

1. Where indicated on the SINTX Purchase Order, suppliers must use SINTX’s customer-approved special process sources (e.g., sterilization, welding, grinding, anodizing, etc.).

2. SINTX is to be contacted (by the supplier) in the event of nonconforming product/material. Arrangements for the approval of supplier nonconforming product/material must be as directed by SINTX’s Director of Quality Assurance or designee.

3. The supplier is required to notify SINTX of any changes to a product and/or process, including changes of external providers or location of manufacture, that may affect conformance to specifications or requirements, and to obtain approval from SINTX’s Director of Quality Assurance or designee, when applicable.

4. SINTX, their customers, and regulatory authorities retain the right of access to all supplier facilities involved in the aerospace order and to all applicable records (which shall be retained for at least two years from date of purchase order).

5. SINTX will require our external providers to flow down and apply appropriate controls to their direct and sub-tier external providers to ensure that product requirements are met. SINTX does not allow its aerospace suppliers to subcontract any of SINTX’s orders or services to a sub-tier supplier without SINTX’s expressed written consent.

6. SINTX performs inspection activities to ensure that purchased product meets purchase requirements. They may include:

a. Provision of test specimens for design approval, inspection/verification, investigation, or auditing.
b. Receiving inspections (of supplier products / services / documents) performed by a designated employee. SINTX verifies the authenticity of the appropriate certificate of conformity, material certificates, etc. and other accompanying documentation by review and comparison (as is appropriate) to the drawing and/or industry specifications or by other means. When necessary, SINTX may inspect or audit at the supplier’s facility.
c. Products are inspected to ensure they meet requirements (dimensions, etc.) and the results are recorded (as appropriate). All special processes (i.e., sterilization, welding, anodizing, grinding, etc.) where the compliance cannot be verified by inspections will require a Certificate of Conformity.
d. At a minimum, product/service conformity and on-time delivery will be monitored by SINTX.

7. When SINTX or its customer intends to perform verification at the supplier’s premises, SINTX will first state the intended verification arrangements and the method of product release. This information will be communicated on the SINTX purchase order, or via another acceptable agreement.

8. To ensure product identification and traceability, SINTX will institute controls that include the requirement of Material Certificates, Certificates of Conformity, and/or other supporting documentation from its suppliers as is appropriate. These requirements may be specified on SINTX’s purchase order, or may otherwise be communicated to the supplier.

9. All special process must be performed by qualified and competent persons.

10. SINTX requires that the supplier have policies and procedures to identify potential counterfeit -parts from suppliers. Suppliers shall immediately notify SINTX with the pertinent facts if the supplier becomes aware of or suspects that counterfeit parts may have been used in a product delivered to SINTX. In the event that products delivered under this order constitutes or includes counterfeit parts, the supplier shall, at its expense, promptly replace such counterfeit parts with genuine parts conforming to the requirements of this order. Notwithstanding any other provision in this order, the supplier shall be liable for all costs relating to the removal and replacement of counterfeit parts.

11. Records are available for review by customers and regulatory authorities in accordance with contract or regulatory requirements.

12. SINTX expects 100% on time delivery. If the agreed upon delivery cannot be met, SINTX must be notified in advance. If SINTX’s supplier evaluation identifies a supplier with poor on-time delivery, a corrective action may be issued.

13. SINTX requires that products and services provided by its Approved Suppliers be 100% free of defects. If SINTX’s supplier evaluations identify a supplier delivering poor quality products and/or services, a corrective action may be issued.

14. SINTX may also require specific actions where timely and/or effective corrective actions to a supplier issue(s) are not achieved. These actions may include but are not limited to any or all of the following: withholding payment until the issue is resolved, removal of the supplier from SINTX’s Approved Supplier List, and/or legal action.

SINTX 108014-15 Rev A (08/20)