Recall Responsibilities. Haemacure shall conduct product recalls, withdrawals or quarantines as required by the FDA, or such voluntary recalls initiated by Haemacure's reasonable belief that the Products violate any provision of applicable law. BPL shall assist Haemacure in all recalls, withdrawals or quarantines relating to the Product. Haemacure and BPL shall share equally all expenses incurred in any such recall, provided however, (a) if such action is taken due to BPL's failure to manufacture the Products in accordance with the Specifications or in breach of its warranties pursuant to Section 6.5, then BPL shall bear all such expenses, including the cost of replacement Product, and (b) if such action is taken due to Haemacure's failure to comply with the Act or the breach of its responsibilities pursuant to this Agreement, then Haemacure shall bear all such expenses, including the cost of replacement Product.
Recall Responsibilities. (a) In accordance with the Quality Assurance Agreement to be entered into by the Parties according to Section 10.14, Delcath shall be the primary point of contact with FDA with respect to any recall of the PHP Systems incorporating the Product. The Parties agree, however, that any recall would be conducted and coordinated in full consultation with the other Party, with Delcath handling the logistics of such recall. The Parties agree that the cost of any recall (including without limitation the costs of notifying the customers, Product recovery, Product destruction, replacement Product and applicable freight, insurance, taxes, customs and duties for all of the above) shall be borne by Delcath unless and to the extent such recall relates to (i) Synerx/Bioniche’s breach of their representations, warranties, or obligations under this Agreement or applicable laws, (ii) Synerx/Bioniche’s negligence or willful misconduct, or (iii) the manufacturing and supply of the Product, in which case, to the extent the recall is related to or results from the events set forth in clauses (i), (ii) or (iii) above, the costs of such recall (including without limitation the costs of notifying the customers, Product recovery, Product destruction, replacement Product and applicable freight, insurance, taxes, customs and duties for all of the above) shall be borne by Synerx/Bioniche. For purposes of this Section, “recall” means any action by Delcath or any Affiliate of Xxxxxxx CONFIDENTIAL TREATMENT [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission. to recover title to or possession of any PHP System incorporating the Product sold or shipped including, but not limited to, market withdrawal.
Recall Responsibilities. Customer will handle all discussions with regulatory agencies regarding manufacturing defects or safety issues related to any Product and will be solely responsible for deciding the necessity, scope, and procedures for any Product recall. SCS will support Product recalls based on the Ad-Hoc rates stated in Exhibit B.
Recall Responsibilities. Each party will have written procedures covering field corrective actions and recall activities, and employees will have appropriate training on these procedures. Each party will promptly notify the other party of any recall or field correction affecting the Product. If a recall or field correction results from a defect in a Seller Product, Seller will be responsible for: (i) the investigation to determine the cause and extent of the problem, while Spacelabs will be responsible for: (iv) locating the Products in question; (v) communications with Customers; (vi) in the event of a recall, requiring that the recalled Products are returned; (vii) in the event of a Product shipment hold, initiating a shipment hold immediately upon notice by Seller; and (viii) requiring and performing field upgrades and/or repairs. If the Product provided by Seller is a finished medical device Product, Seller will be responsible for all regulatory authority contacts and (overall coordination of any corrective activities involving the Products. The Parties will cooperate fully with each other in effecting any recall of a Product. Seller will bear all costs and expenses of such field correction or recall, including, without limitation, the cost of notifying Spacelabs’ Customers and costs associated with sending a service engineer to perform field correction and/or shipment of recalled Products from Spacelabs’ Customers to Seller, as well as the costs associated with providing Spacelabs’ Customers with replacement or modified Products.
