Common use of COMPLAINTS, QUALITY RECORDS AND RECALLS Clause in Contracts

COMPLAINTS, QUALITY RECORDS AND RECALLS. 19.1 Distributor will notify, in writing, AMS's quality assurance department of all Product complaints or any regulatory/conformance issues that may affect the marketability of Products. AMS shall notify the appropriate regulatory agent(s) if required and shall conduct any safety investigations or other necessary follow-up activities. Distributor will provide any information essential to such activities. AMS will promptly notify Distributor if corrective action is necessary in the Territory. 19.2 Distributor shall keep records of the names and addresses of customers and Product serial numbers for the active Product life to enable Distributor to notify customers of Product safety information. Distributor shall maintain the following information when distributing AMS's Products: - Name and address of initial consignee - Identification of device and quantity of devices shipped - Date of shipment 19.3 Upon request, Distributor will supply AMS a quarterly report of repairs, maintenance or service activity for Products. The report will include the product number, serial number, fault found, action taken and date of the activity. 19.4 In the event of any recall of a Product required by a governmental agency for safety or efficacy reasons, or requested by Aspect at its sole discretion, which is the result of AMS's failure to supply Products that (1) conform in all material respects to the applicable published specifications or (2) are free from defects in material and workmanship (when given normal, proper and intended usage), AMS agrees to repair or replace at its own costs all Products subject to the recall and previously delivered to Distributor. AMS also agrees to consult with Distributor to establish a reasonable process for managing the recall and Aspect shall be responsible for all reasonable out-of-pocket expenditures incurred by Distributor (including, but not limited to shipping costs, labor and travel costs) that are consistent with the recall process agreed to by the Parties.. In the event the recall is not required by a governmental agency for safety or efficacy reasons, but is instead requested by AMS at its sole discretion, AMS will be responsible for determining the scope of the recall, including the number of units, timeframe for the recall, and criteria for completion. Distributor agrees to maintain all necessary sales records to facilitate the recall. MEDICAL PRODUCTS DISTRIBUTION AGREEMENT

COMPLAINTS, QUALITY RECORDS AND RECALLS. 19.1 Distributor will notify, in writing, AMS's quality assurance department of all Product complaints or any regulatory/conformance issues that may affect the marketability of Products. AMS shall notify the appropriate regulatory agent(s) if required and shall conduct any safety investigations or other necessary follow-up activities. Distributor will provide any information essential to such activities. AMS will promptly notify Distributor if corrective action is necessary in the Territory. 19.2 Distributor shall keep records of the names and addresses of customers and Product serial numbers for the active Product life to enable Distributor to notify customers of Product safety information. Distributor shall maintain the following information when distributing AMS's Products: - Name and address of initial consignee - Identification of device and quantity of devices shipped - Date of shipment 19.3 Upon request, but not more than once per year, Distributor will supply AMS a quarterly report of repairs, maintenance or service activity for Products. The report will include the product number, serial number, fault found, action taken and date of the activity. 19.4 In the event of any corrective or preventive action, including, without limitation recall or field correction of a Product required by a governmental agency for safety or efficacy reasons, or requested by Aspect at its sole discretionAMS, which is the result of AMS's failure to supply Products that (1) conform in all material respects to the applicable published specifications or (2) are free from defects in material and workmanship (when given normal, proper and intended usage)workmanship, AMS agrees to repair or replace at its own costs cost all Products subject to the recall corrective or preventive action and previously delivered to Distributor. AMS also agrees to consult with Distributor to establish a reasonable process for managing the recall corrective or preventive action and Aspect AMS shall be responsible for all reasonable out-out- MEDICAL PRODUCTS DISTRIBUTION AGREEMENT of-pocket expenditures incurred by Distributor (including, but not limited to shipping costs, labor and travel costs) that are consistent with the recall corrective or preventive action process agreed to by the Parties.. . In the event the recall corrective or preventive action is not required by a governmental agency for safety or efficacy reasons, but is instead requested by AMS at its sole discretion, AMS will be responsible for determining the scope of the recallsuch action, including the number of units, timeframe for the recallaction, and criteria for completion. In such event AMS shall be liable for the cost of repair or replacement and reimbursement of costs to Distributor as set forth above. Distributor agrees to maintain all necessary sales records to facilitate the recall. MEDICAL PRODUCTS DISTRIBUTION AGREEMENTcorrective or preventive action.

COMPLAINTS, QUALITY RECORDS AND RECALLS. 19.1 Distributor will notify, in writing, AMS's quality assurance department of all Product complaints or any regulatory/conformance issues that may affect the marketability of Products. AMS shall notify the appropriate regulatory agent(s) if required and shall conduct any safety investigations or other necessary follow-up activities. Distributor will provide any information essential to such activities. AMS will promptly notify Distributor if corrective action is necessary in the Territory. 19.2 Distributor shall keep records of the names and addresses of customers and Product serial numbers for the active Product life to enable Distributor to notify customers of Product safety information. Distributor shall maintain the following information when distributing AMS's Products: - Name and address of initial consignee - Identification of device and quantity of devices shipped - Date of shipment 19.3 Upon request, but not more than once per year, Distributor will supply AMS a quarterly report of repairs, maintenance or service activity for Products. The report will include the product number, serial number, fault found, action taken and date of the activity. 19.4 In the event of any corrective or preventive action, including, without limitation recall or field correction of a Product required by a governmental agency for safety or efficacy reasons, or requested by Aspect at its sole discretionAMS, which is the result of AMS's failure to supply Products that (1) conform in all material respects to the applicable published specifications or (2) are free from defects in material and workmanship (when given normal, proper and intended usage)workmanship, AMS agrees to repair or replace at its own costs cost all Products subject to the recall corrective or preventive action and previously delivered to Distributor. AMS also agrees to consult with Distributor to establish a reasonable process for managing the recall corrective or preventive action and Aspect AMS shall be responsible for all reasonable out-of-pocket expenditures incurred by Distributor (including, but not limited to shipping costs, labor and travel costs) that are consistent with the recall corrective or preventive action process agreed to by the Parties.. . In the event the recall corrective or preventive action is not required by a governmental agency for safety or efficacy reasons, but is instead requested by AMS at its sole discretion, AMS will be responsible for determining the scope of the recallsuch action, including the number of units, timeframe for the recallaction, and criteria for completion. In such event AMS shall be liable for the cost of repair or replacement and reimbursement of costs to Distributor as set forth above. Distributor agrees to maintain all necessary sales records to facilitate the recallcorrective or preventive action. MEDICAL PRODUCTS DISTRIBUTION AGREEMENTAGREEMENT Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.