Common use of Recall Assistance Clause in Contracts

Recall Assistance. 19.1 Client is responsible for decision to initiate recall or product withdrawal. 19.2 Client is responsible for notification of recall or product withdrawal to appropriate regulatory agencies. 19.3 Client is responsible for management of a recall event. 19.4 If there is a recall or withdrawal of Product, then Cardinal Health agrees to stop shipping recalled lots promptly, and in no event later than twenty-four (24) hours after Cardinal Health receives written notification of such recall from Client. 19.5 If mutually agreed upon, Cardinal Health will provide assistance to Client and cooperate fully in any such recall. Client will pay to Cardinal Health an amount equal to Cardinal Health’s actual costs incurred with any such recall services. Such cost will be in addition to the fees set forth in the Fee Schedule. Such assistance will include but not be limited to: a) Contacting consignees (wholesaler, ship to locations) who may have received affected Product and requesting prompt quarantine of all affected lots pending further disposition instructions from Cardinal Health or Client. b) Storage and control of on-hand inventory of recalled Product. c) Receipt, storage and control of returned recalled Product. d) Documentation of recalled Product used, destroyed or returned to the distributor through established document systems at Cardinal Health. e) Assistance in preparation of final Recall Report including a copy of all communications, if any, with FDA concerning the recall. f) Shipment of samples of recalled Product to Client or a designated testing site for analysis, if applicable. g) Cardinal Health will maintain appropriate SOPs, and to the extent that they are not in conflict with the Operating Guidelines, Cardinal Health will follow its SOPs with regard to executing these requirements. 19.6 Cardinal Health will provide the necessary recall reports within two (2) hours of notification by Client. Reports will contain, but not be limited to, the following information for each recalled Product and lot number: Customer shipments by date, item number, quantity, lot number, and ship to address. 19.7 Cardinal Health will provide Client Quality Assurance with signed and dated records documenting final disposition of the Product(s). In addition, Cardinal Health will assist with the following information: a) Name and location of distributors involved in the execution of the final disposition of the recalled Product. b) Name and location of drug destruction sites (if applicable). c) List of applicable State or Federal licenses currently required and held for drug transport and/or disposal for all drug destruction sites (if applicable). d) Product disposition method. e) Amount of Product dispositioned.

Recall Assistance. 19.1 20.1 Client is responsible for decision to initiate recall or product withdrawal. 19.2 20.2 Client is responsible for notification of recall or product withdrawal to appropriate regulatory agencies. 19.3 20.3 Client is responsible for management of a recall event. 19.4 20.4 If there is a recall or withdrawal of Product, then Cardinal Health agrees to stop shipping recalled lots promptly, and in no event later than twenty-four (24) hours [**] after Cardinal Health receives written notification of such recall from authorized representative of Client. 19.5 20.5 If mutually agreed upon, Cardinal Health will provide assistance to Client and cooperate fully in any such recall. Client will pay to Cardinal Health an amount equal to Cardinal Health’s actual costs incurred with any such recall services. Such cost will be in addition to the fees set forth in the Fee Schedule. Such assistance will include but not be limited to: a) 20.5.1 Contacting consignees (wholesaler, ship to locations) who may have received affected Product and requesting prompt quarantine of all affected lots pending further disposition instructions from Cardinal Health or Client. b) 20.5.2 Storage and control of on-hand inventory of recalled Product. c) 20.5.3 Receipt, storage and control of returned recalled Product.. ActiveUS 172391979v.1 d) 20.5.4 Documentation of recalled Product used, destroyed or returned to the distributor through established document systems at Cardinal Health. e) 20.5.5 Assistance in preparation of final Recall Report including a copy of all communications, if any, with FDA concerning the recall. f) 20.5.6 Shipment of samples of recalled Product to Client or a designated testing site for analysis, if applicable. g) 20.5.7 Cardinal Health will maintain appropriate SOPs, . If there is any conflict between the Cardinal Health SOPs and to the extent that they are not in conflict with the Operating Guidelines, Cardinal Health will follow its SOPs with regard to executing these requirements. 19.6 20.6 Cardinal Health will provide the necessary recall reports within two (2) hours [**] of notification by Client. Reports will contain, but not be limited to, the following information for each recalled Product and lot number: Customer shipments by date, item number, quantity, lot number, and ship to address. 19.7 20.7 Cardinal Health will provide Client Quality Assurance with signed and dated records documenting final disposition of the Product(s). In addition, Cardinal Health will assist with the following information: a) 20.7.1 Name and location of distributors involved in the execution of the final disposition of the recalled Product. b) 20.7.2 Name and location of drug destruction sites (if applicable). c) 20.7.3 List of applicable State or Federal licenses currently required and held for drug transport and/or disposal for all drug destruction sites (if applicable). d) 20.7.4 Product disposition method. e) 20.7.5 Amount of Product dispositioned.

Recall Assistance. 19.1 Client is responsible for decision to initiate recall or product withdrawal. 19.2 Client is responsible for notification of recall or product withdrawal to appropriate regulatory agencies. 19.3 Client is responsible for management of a recall event. 19.4 If there is a recall or withdrawal of Product, then Cardinal Health agrees to stop shipping recalled lots promptly, and in no event later than twenty-four (24) hours after Cardinal Health receives written notification of such recall from Client. 19.5 If mutually agreed upon, Cardinal Health will provide assistance to Client and cooperate fully in any such recall. Client will pay to Cardinal Health an amount equal to Cardinal Health’s actual costs incurred with any such recall services. Such cost will be in addition to the fees set forth in the Fee Schedule. Such assistance will include but not be limited to: a) Contacting consignees (wholesaler, ship to locations) who may have received affected Product and requesting prompt quarantine of all affected lots pending further disposition instructions from Cardinal Health or Client. b) Storage and control of on-hand inventory of recalled Product. c) Receipt, storage and control of returned recalled Product. d) Documentation of recalled Product used, destroyed or returned to the distributor through established document systems at Cardinal Health. e) Assistance in preparation of final Recall Report including a copy of all communications, if any, with FDA concerning the recall. f) Shipment of samples of recalled Product to Client or a designated testing site for analysis, if applicable. g) Cardinal Health will maintain appropriate SOPs, and to the extent that they are not in conflict with the Operating Guidelines, Cardinal Health will follow its SOPs with regard to executing these requirements. 19.6 Cardinal Health will provide the necessary recall reports within two (2) hours of notification by Client. Reports will contain, but not be limited to, the following information for each recalled Product and lot number: Customer shipments by date, item number, quantity, lot number, and ship to address. 19.7 Cardinal Health will provide Client Quality Assurance with signed and dated records documenting final disposition of the Product(s). In addition, Cardinal Health will assist with the following information: a) Name and location of distributors involved in the execution of the final disposition of the recalled Product. b) Name and location of drug destruction sites (if applicable). c) List of applicable State or Federal licenses currently required and held for drug transport and/or disposal for all drug destruction sites (if applicable). d) Product disposition method. e) Amount of Product dispositioned. f) Date of Product disposition. g) Documentation from each affected Distributor(s) head of Quality Assurance or designee attesting to the completion of the Product disposition functions and requirements set forth by Client’s Recall Committee.