Effective date : 02/15/2023

TERMS AND CONDITIONS OF PURCHASE

AGREEMENT.  This purchase order and any supplemental terms and conditions or additional documents referenced in the body of the purchase order ("PO") constitute the only contract and understanding, whether oral or written, between Custom Manufacturing Inc. or its affiliate issuing this PO ("CMI") and the party identified as Supplier on the face of this PO ("Supplier") for the goods, products or services ordered hereunder ("Products and/or Services"). Documents designated by CMI in the body of the PO, including supplemental terms and conditions, if any, are incorporated by reference the same as if set out in full therein and will form a part of the PO. Supplier acknowledges that no invoice, shrink-wrap, click-wrap, or other terms and conditions or agreement provided with any products or software shall be binding on CMI, even if use of such Products and software requires and affirmative acceptance and such terms shall be of no force or effect and shall be deemed rejected by CMI. To the extent CMI and Supplier are party to a valid, current, executed written agreement the scope of which includes the purchase of Products and/or Services that are the subject of this PO ("Agreement") then, the terms of such Agreement shall govern and control. If there is no such Agreement the terms and conditions of this PO shall govern. If there is an applicable Quality Agreement in place with the Supplier that shall govern first. All conflicting, different, or additional Supplier terms are expressly rejected, and acceptance of this offer is expressly limited to the terms stated in this PO. No course of dealing or usage of trade or actual course of performance shall be relevant to explain or supplement any terms used herein. A CMI affiliate is an entity that directly, or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with CMI.

PURCHASE / SALES ORDERS FOR CUSTOMERS CUSTOM ORDERED OR DESIGNED PRODUCTS. Purchase orders received from the Customer for any customer designed or custom ordered products, that has been acknowledged by “CMI”, are considered a binding contract for the purchase of those products listed on that Purchase Order by the Customer and cannot be canceled without the expressed written consent of “CMI”. Due to the nature of custom ordered products, and the need for “CMI” to acquire specific customer required raw materials in bulk and in advance to ensure the deliverability of the product to the customer on the requested ship dates, customer required raw material inventory is considered customer required inventory. Furthermore, the Customer is responsible for the purchase of any finished product from any accepted and acknowledged blanket purchase older with any remaining line items at the time of any change request or discontinuation of any Customers product using customer required raw material inventory. The acquisition cost of the customer required inventory is considered the responsibility of the Customer upon discontinuation of any Customer product manufactured by “CMI” that uses customer required inventory. The acceptance of any Customers purchaser order or Sales Order for a custom designed product that requires “CMI” to pre purchase customer required inventory in bulk for the manufacturing of the products on the Purchase Order, is considered the acceptance by the Customer for the acquisition costs of the customer required inventory upon discontinuation of the product the customer required inventory was purchased for.  The Customer is responsible for reimbursement to “CMI” for the acquisition cost of the customer required inventory if manufacturing of the product that uses the customer required inventory is ever discontinued with “CMI”.  The acquisition cost of the customer required inventory, not already used in the manufacturing of the Customers finished product prior to discontinuation of any custom product, is considered the Customer’s acquisition cost for the customer required inventory. Upon notification by Customer to “CMI” of the discontinuation of any Customers custom order product,” CMI” will provide the Customer with an invoice for any Customer finished products for any outstanding line items from existing acknowledged Purchase Orders within thirty (30) business days of these items shipping. Upon notification by Customer to “CMI” of the discontinuation of any Customers custom order product,” CMI” will provide the Customer with an invoice for any customer required inventory remaining on hand at the time of said notification. Within sixty (60) days of receipt of such invoice from “CMI” by Customer as a result of a notice of discontinuation of any product, the Customer agrees to submit a new Purchase Order to “CMI” for any remaining customer required inventory on hand at “CMI” for the customers custom products. Payment terms for discontinued products with customer required inventory are the same as the existing payment terms for the purchase of finished products.

QUANTITIES AND PRICE. The specific quantity ordered must be delivered in full and not be changed without CMI's prior written consent. Any different quantity without such consent is subject to CMI's rejection and return at Supplier's expense and CMI shall have no obligation for payment of any excess quantity. The price for the Products and/or Services shall be the price as indicated on the face of this PO. Any change in price without CMI's prior written consent and issuance of an amended PO is expressly rejected. No additional charges of any kind will be allowed except with CMI's prior written consent.

PAYMENT TERMS.  Unless otherwise agreed, payment of an undisputed invoice shall be made via electronic funds transfer net 90 days from the date of receipt of an acceptable invoice. If CMI disputes all or a portion of an invoice, CMI may withhold such disputed amounts, and will promptly notify Supplier of the amount and reason for the dispute. All invoices must include the PO number and a detailed description of the Products and/or Services provided. CMI reserves the right not to pay any invoice issued more than 180 calendar days from the date originally required hereunder. All invoices shall be emailed as directed on the face of this PO. Fees are exclusive of applicable value-added, sales, use, excise, customs duties, or other similar taxes (" Taxes"), relating to the sale, purchase, transfer of ownership, delivery, installation, license, or provision of the Products and/or Services under the PO. CMI shall be responsible for the Taxes.

DELIVERY AND ACCEPTANCE. Time is of the essence in the performance of this PO, and any delay in delivery is a material breach. Title transfers to CMI upon delivery of the Products to CMI. Unless otherwise agreed, shipment of the Products shall be freight collect via CMI designated mode and carrier. If Supplier fails to comply, shipment is FCA destination with Supplier bearing the risk of loss and cost of delivery and CMI assumes no liability for loss or damage occurring prior to CMI's receipt. CMI is entitled to inspect the Products and/or Services (including the performance of tests) before or after receipt and reject them for failure to conform to this PO, regardless of whether any payment has been made by CMI, whether the nonconformity substantially impairs the value of the Products and/or Services, or whether the nonconformity may be cured by Supplier. CMI has the right upon reasonable notice to enter Supplier's facilities to inspect the production of Products and/or performance of Services, without precluding subsequent inspection and rejection of Products and/or Services. If the inspection discloses, in CMI's good faith opinion, that Supplier's ability to meet the requirements of this PO is questionable, CMI may treat such circumstance as a material breach and terminate this PO without liability to Supplier. If Products tendered pursuant to this PO are nonconforming, CMI may return all the Products to Supplier, at Supplier's expenses, for first priority repair, replacement or a refund at the election of CMI.

CONFIDENTIALITY. Supplier may not disclose to any third party (other than a government or judiciary body, as required by law, and only with prior written notice to CMI of any such disclosure), or use any information, including personal data, Supplier receives or learns about CMI or its affiliates in connection with or as a result this PO, including without limitation, the existence or details of this PO or any agreement or arrangement with CMI except as is necessary to perform this PO.

COMPLIANCE WITH LAW. Each party shall be responsible for ensuring that the performance of its respective obligations under this PO complies with all applicable local, state, federal, and international laws, rules, and regulations, whether in effect now or in the future (collectively, the "Laws"). Specifically, Laws shall include but not be limited to: TCPA, COPPA, FCRA, the Reform Act, HIPAA, privacy laws, environmental regulations, the FFDCA, and all international trade Laws, including but not limited to economic sanctions, anti-boycott, and Laws governing the import, export or any other transfer or provision of Products and/or Services. Additionally, Supplier shall adhere to all applicable laws relating to labor, environmental, health/safety and ethics, as well as MDT's Global Supplier Standards and any applicable CMI policies. Supplier may find more information online at

(http://www.CUSTOMMANUFACTURINGINC.com).

EQUAL OPPORTUNITY; NONDISCRIMINATION. CMI and Supplier shall, to the extent they apply, abide by the requirements of 41 CFR  60-1.4(a), 60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, prohibit discrimination against all individuals based on their race, color, religion, sex, or national origin and require affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status or disability. Supplier shall comply with all applicable labor laws, rules, and regulations, including but not limited to, all laws forbidding the solicitation, facilitation, or any other use of slavery or human trafficking. To the extent applicable, CMI incorporates by reference 29 Code of Federal Regulations ("CFR") Part 471, Appendix A to Subpart A, as well as any Federal Acquisition Regulation ("FAR") clauses at 48 CFR Part 52 in effect as of the date of the PO, including but not limited to the E-Verify obligations described in FAR 52.222-54. If

Supplier is required by federal Regulations to file Employer Information Report EEO-1 (standard form 100) or Federal Contractor Veterans Employment Report VETS-100A, Supplier certifies that it has done so or will file such reports in accordance with applicable instructions and will continue to file such reports unless or until no longer required by applicable law.

QUALITY CLAUSES

GENERAL: The following quality clauses apply to all purchases that have the potential to impact the quality of the Product and/or Services provided by CMI or CMI's quality management system. Any conflict between the terms in the PO these Quality Clauses relate to and the Quality Clauses themselves shall be resolved in favor of these Quality Clauses.

MANAGEMENT RESPONSIBILITY.  Supplier's management shall provide the resources necessary to implement and maintain a quality management system (QMS), including monitoring of its effectiveness.

SUB-CONTRACTING.  Supplier shall not subcontract any of the work subject to this PO without prior written approval by CMI.

REGULATORY SUPPORT.  Upon request, Supplier shall provide information necessary for CMI to obtain regulatory approval for the marketing, sale, and distribution of CMI products into which the Supplier's Products or Services are incorporated.  Such information may include specific details relating to raw materials, composition, ingredients, etc.

QUALITY MANAGEMENT SYSTEM.  Supplier shall, during fulfilment of all accepted POs, maintain a QMS that monitors all aspects of the work performed.  QMS shall include, at a minimum: documented procedures as required by the QMS, documents needed by the organization to ensure the effective planning, operation and control of its processes, and records required by the QMS. Monitoring (i.e., internal audits) to ensure compliance with its QMS, procedures, any applicable standards and MDT requirements.

RECORDS.  Supplier shall keep complete records that provide evidence of conformity to all requirements of the QMS. Records shall be maintained in a manner that allows them to be readily retrievable and to prevent deterioration, damage, or loss. Electronic approval and storage of records is expected to comply with FDA 21 CFR Part 11 requirements. Unless record retention, responsibilities are otherwise agreed with CMI, supplier shall maintain records for 15 years, or a time period as required by applicable laws, rules or regulations, whichever is greater. Records shall be made available for inspection by CMI, its representatives, any relevant regulatory authority such as a Notified Body or FDA, or a government authority.

COMPETENCY AND TRAINING.  Supplier shall provide adequate and competent personnel for the fulfilment of the PO.

WORK ENVIRONMENT. Supplier shall maintain an appropriate infrastructure, work environment, and cleanliness of personnel to prevent adverse effects on product or service quality.

CONTROL OF SPECIFICATIONS. Supplier shall control the distribution and use of all specifications and documents pertaining to the PO. To the extent there is a conflict between product specifications provided to Supplier by CMI and the requirements herein, the product specifications shall govern.

IDENTIFICATION AND TRACEABILITY.  Supplier shall maintain identification and traceability of raw materials, components and products during all stages of receipt, processing, test, storage,

TERMS AND CONDITIONS OF PURCHASE

shipment and distribution.

CONFORMANCE TO REQUIREMENTS:  Supplier warrants that the Products and/or Services will be free from defects in materials, workmanship and design and are supplied to CMI in accordance with the specifications, drawings and other written instructions provided with this PO.  For Services purchased from Supplier, all such Services shall be performed in a good and workmanlike manner, consistent with all applicable industry standards.

CONTROL OF NON-CONFORMANCES.  Supplier shall have a process and procedures in place for the control of non-conforming Products or Services at all stages of Supplier's operations, which includes identification, documentation, evaluation, segregation and disposition of the nonconforming product or service conditions. Supplier shall have procedures that govern rework of

non-conforming product.

ESCAPES. In the event Supplier discovers a non-conformance that affects Products already shipped or Services performed, Supplier shall promptly notify CMI. Supplier shall fully cooperate with all investigation and containment actions.  Supplier shall reimburse all costs and expenses incurred by CMI in connection with use of Nonconforming Product. CMI may return all nonconforming Products to Supplier, at Supplier's expenses.

CAPA.  Supplier shall maintain procedures for Corrective and Preventive Action (CAPA).  Where a product or service is identified by CMI as nonconforming, CMI may issue a supplier CAPA. Supplier shall complete all necessary CAPA activities within mutually agreed timeframes.

PROCESS CONTROL. Supplier shall control processes that affect product or service quality and performance, including but not limited to: approval of processes and process equipment including qualification and where appropriate, validation, monitoring and control of process parameters, including a documented control plan, if required, and compliance with all specified reference standards. CMI reserves the right to review and approve Supplier's qualification/validation plans and reports.

EQUIPMENT CONTROL, MAINTENANCE AND CALIBRATION. Supplier shall have documented systems in place to ensure process and test equipment is controlled, maintained, and calibrated at stated frequencies, to ensure it is suitable for its intended purpose and is capable of producing valid results.  Product potentially impacted by use of out of calibration equipment shall be treated as Nonconforming Product.   Calibration standards shall be traceable to recognized national and/or international standards, including NIST.

CONTROL OF SUB-TIER SUPPLIERS.  Supplier shall maintain controls, commensurate with risk, for the quality of all Products and Services procured in connection with the performance of work subject to the PO.   Controls must include, as applicable, the flow down of applicable CMI requirements and ensuring action is taken when sub-tier performance is not acceptable.

ACCEPTANCE ACTIVITIES.  Supplier shall maintain processes to ensure Products or Services conform to CMI requirements, including as appropriate, incoming, in-process and final acceptance activities. Records of acceptance activities shall be maintained. Records shall include the acceptance activity performed, date performed, the results, the individual conducting the acceptance activity and the equipment used.  Where required by CMI, Supplier shall provide a Certificate of Conformance and/or Analysis for each lot or batch of product shipped, or for the service provided.

CHANGE CONTROL.  Any process changes, design changes or deviations considered by the Supplier and/or sub-tier must be submitted to CMI for review and must include a detailed description of the change and its effects to the Products and/or Services characteristics.

AUDITS/INSPECTIONS Supplier agrees that CMI, any government, notified body, commission, board, regulatory agency, court or other instrumentality having any jurisdiction over all aspects of the design, manufacturing and distribution of the Products ("Authority"), shall have access to and the right to inspect or audit any pertinent Product manufacturing or quality processes, and associated documentation or records.  The Supplier may specifically be subject to scheduled or unannounced audits (per EU Recommendation 2013/473/EU).  During unannounced audits, the Supplier must allow the Authority to witness the testing of Product samples, and/or if requested, provide samples of Product for independent testing by the Authority.  If issues or findings are identified during an audit that potentially impact product or service quality, performance or availability, Supplier shall promptly notify CMI and agree to cooperate regarding communications with FDA, regulatory, or government authority.

LABELING, PACKAGING, HANDLING & STORAGE Supplier shall ensure that packaging and shipping containers are of adequate design and construction to protect product from damage, deterioration or alteration during handling, storage, and distribution.  Expiration dates and any required storage conditions shall be clearly recorded on the labelling, packaging, and shipping documents.  Supplier shall create and store labels and perform labelling operations in a way that prevents an incorrect label from being used.

SHIPMENT Supplier shall have systems in place to control shipment of Products so that only Products approved for release are shipped. Supplier shall ensure that no obsolete, rejected, expired, or deteriorated Products are shipped.

COMPLAINTS Supplier shall provide assistance and information requested by CMI in relation to the investigation of complaints CMI receives from its customers, and to fulfil its regulatory reporting obligations.  Where the complaint is confirmed to be attributed to the product or service provided, Supplier shall follow the CAPA process.

RESTRICTED SUBSTANCES/MATERIAL DECLARATION: Products and Services supplied to CMI are expected to meet all applicable requirements of country, federal, state, and local environmental regulations.   Suppliers of packaging, components and finished devices (Products) are expected to provide information about the specific composition (e.g., trade or chemical name, color, grade, etc.), including quantity of all constituents used in the Products and packaging and/or provide specific certifications to CMI upon request. This detailed information, declaring the raw materials and process chemicals used to manufacture the Products and packaging is required to fulfill Regulatory Body requirements for approval for use and other environmental reporting obligations.

RECALLS: Supplier shall promptly notify CMI in writing in the event Products or Services provided become subject to a supplier or Authority initiated recall and shall cooperate with CMI requests for information related to the recall.   CMI has the sole authority for decisions related to any of its products in the field, including any field corrective action.

SURVIVAL: All quality requirements which are continuing in nature, including but not limited to CAPA, nonconforming product, escapes, authority audits & inspections, record retention, complaints, recalls, shall survive termination or cancellation of the PO.