Recall Assistance. Subdistributor shall assist the Distributor and its Suppliers in effectuating any recall of the Products;
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...
Recall Assistance. 18.1 Client is responsible for management of a recall event.
18.2 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.
18.3 If mutually agreed upon, Cardinal Health shall provide assistance to Client and cooperate fully in any such recall. Client shall pay to Cardinal Health an amount equal to Cardinal Health's actual costs incurred with any such recall services. Such cost shall be in addition to the fees described in Exhibit C to the Agreement. Such assistance shall include but not be limited to:
18.3.1 Working with Client to assist in the development of a recall strategy 183.2 Contacting consignees (wholesaler, customers) who may have received affected Product and requesting prompt quarantine of all affected lots pending further disposition instructions from Cardinal Health or Client.
Recall Assistance a. See Section 1.19
Recall Assistance. 16.1 Client is responsible for management of a recall event.
16.2 If there is a recall or withdrawal of Product, then Vendor agrees to stop shipping recalled lots promptly, and in no event later than twenty-four (24) hours after Vendor receives written notification of such recall.
16.3 If mutually agreed upon, Vendor shall provide assistance to Client and cooperate fully in any such recall. Client shall pay to Vendor an amount equal to Vendor "s actual costs incurred with any such recall services. Such cost shall be in addition to the Fees described in Exhibit C to the Agreement. Such assistance shall include but not be limited to:
16.3.1 Working with Client to assist in the development of a recall strategy
16.3.2 Contacting consignees (wholesaler, customers) who may have received affected Product and requesting prompt quarantine of all affected lots pending further disposition instructions from Vendor or Client.
16.3.3 Storage and control of on-hand inventory of recalled Product.
16.3.4 Receipt, storage and control of returned recalled Product.
16.3.5 Documentation of recalled Product used, destroyed or returned to the distributor through established document systems at Vendor.
16.3.6 Preparing final Recall Report including a copy of all communications, if any, with FDA concerning the recall.
16.3.7 Shipment of samples of recalled Product to Client or a designated testing site for analysis, if applicable.
16.3.8 Vendor shall maintain appropriate cGMP SOPs, and to the extent that they are not in conflict with the Operating Guidelines or cGMPs, Vendor will follow its SOPs with regard to executing these requirements.
16.3.9 Vendor will be responsible for executing, or otherwise overseeing, the disposition of recalled Product in accordance with the decision set forth by Client's Recall Committee.
16.4 Vendor will provide the necessary recall reports within two hours of notification by Client. Reports will contain, but not be limited to, the following information for each recalled Product and lot number: all Customer shipments by date, item number, quantity, lot number, and ship to address.
16.5 Vendor shall provide Client Quality Assurance with signed and dated records documenting final disposition of the Product(s). In addition, Vendor will assist with the following information:
16.5.1 Name and location of distributors involved in the execution of the final disposition of the recalled Product
16.5.2 Name and location of drug destruction sites (if applicable)...
Recall Assistance. 9.1 CLIENT is responsible for management of a recall event, including but not limited to preparation of the letter of notification to customers, coordination and reporting with FDA, tracking of recalled product by customer, follow up letters to customers, and final disposition of product.
9.2 CORD will provide the necessary recall reports within two hours of notification by CLIENT. Reports will contain, but not be limited to, the following information for each recalled product and lot number: all customer shipments by date, item number, quantity, lot number, and ship to address.
9.3 CORD will provide a secure area for the receipt of recalled product. CORD will assist CLIENT with inventory reconciliation.
9.4 CORD will provide destruction services for recalled product as may be required by CLIENT.
Recall Assistance a. See Section 1.8 10. SYSTEMS
d. Portions of this exhibit have been omitted pursuant to a request for confidential treatment and have been filed separately with the Commission.
Recall Assistance. If there is a CANNABELLA product recall, the Stockist must:
