Responsibility for Recall Costs. To the extent any Recall or Seizure of API or any Drug Product results from FFFC manufacturing defects in any API supplied by FFFC (for example, due to FFFC’s failure to manufacture a API included in such Drug Product in accordance with the API Specifications or cGMP), or otherwise arises out of, or is connected with any inaccuracy in, breach of, or non-fulfillment of, any representation, warranty, covenant or other obligation of FFFC under this Agreement, or any negligence, recklessness, willful misconduct, or failure to conform with the explicit quality standards or quality obligations imposed on FFFC in the Quality Agreement on the part of FFFC, its Affiliates, or its or its Affiliates’ directors, officers, employees, vendors or agents, then FFFC shall pay all the reasonable, documented, direct costs of such Recall or Seizure, including such costs incurred by Cempra, any Affiliate thereof, or any licensee of Cempra or any Affiliate with respect to the reasonable conduct of any such Recall or Seizure, including but not limited to shipping costs, repurchases, notification letters, direct shipping expenses, and the costs of disposal and/or destruction of the Recalled items, and other direct costs and expenses directly related to such Recall or Seizure (such as costs of administering any Recall), provided that if such Recall or Seizure results from negligence, intentional misconduct, or failure of both Parties, Cempra and FFFC shall bear such costs and expenses pro rata in accordance with their share of fault, which shall be discussed in mutual good-faith and reasonable consultations between the Parties (for purpose of clarification, API, supplied by FFFC under this Agreement, that (x) was not manufactured, stored, or released by or on behalf of FFFC in accordance with the API Specifications or cGMP or (y) did not conform with the explicit quality standards or quality obligations imposed on FFFC in the Quality Agreement with respect to such API, shall, solely for purposes of this proviso, constitute such negligence, intentional misconduct, or failure on the part of FFFC). Notwithstanding the foregoing, FFFC shall have no obligation to pay costs of a Recall or Seizure of any Drug Product to the extent such Recall or Seizure is: (a) due to defects in the Drug Product other than those arising out of (x) manufacturing defects in the API as supplied by FFFC or (y) any inaccuracy in, breach of, or non-fulfillment of, any representation, warranty, covenant or othe...
Responsibility for Recall Costs. (a) If Supplier conducts a Recall of any API, Supplier shall bear the costs of the Recall.
(b) If Customer conducts a Recall of any Recro Product containing API, or if a Regulatory Authority requests or conducts a recall of API or any Recro Product containing API, Customer shall each bear the costs of the Recall except to the extent that the Recall is due to or caused by any of the following:
(i) any breach of any of the representations or warranties of Supplier, or other breach of this Agreement by or on behalf of Supplier, including, without limitation, failure of the API or Recro Product incorporating such quantity of API to meet Agreed Quality; or
(ii) the negligence, recklessness or willful misconduct of, or a breach of a statutory duty by, Supplier and its respective Affiliates or agents.
(c) For purposes of this Agreement, such costs shall include the expenses of notification and destruction or return of the recalled or withdrawn API or Recro Product and all other documented out-of-pocket costs incurred in connection with such Recall but shall not include lost profits or opportunity costs of either Party. If Supplier is responsible for the Recall as set out above, Supplier shall also provide replacement API and/or reimburse Customer for costs as provided in Section 3.9. Any disputes between the Parties regarding responsibility for Recall costs shall be resolved in accordance with Section 12.15.
Responsibility for Recall Costs. In the event that it is ruled by arbitration or in a court of Law, or as otherwise agreed by the Parties, that a recall resulted from, arose out of, or is connected with any inaccuracy in, breach of, or non-fulfillment of, any representation, warranty, covenant or other obligation of Hovione, or any negligent, reckless or willful misconduct or omissions of Hovione, its directors, officers, employees, vendors or agents, Hovione shall reimburse Allos for: (a) any costs expended by Allos to effect the recall, including, but not limited to, all notification letters, all direct shipping expenses, and the costs of disposal and/or destruction of the recalled items; (b) any Production Fees for API involved in such recall and for any other API that cannot be shipped due to the recall; (c) shipping fees paid for the Product and/or API involved in such recall. Hovione’s obligation to reimburse Allos shall be subject to the arbitration and other dispute procedures set forth in Article 15. Hovione’s total aggregate liability for recalls costs associated with a recall shall not exceed a value equal to [ * ].
Responsibility for Recall Costs. (a) If Supplier conducts a Recall of any API, Supplier shall bear the costs of the Recall.
(b) If Customer conducts a Recall of any Recro Product containing API, or if a Regulatory Authority requests or conducts a recall of API or any Recro Product containing API, Customer shall each bear the costs of the Recall except to the extent that the Recall is due to or caused by any of the following:
(i) any breach of any of the representations or warranties of Supplier, or other breach of this Agreement by or on behalf of Supplier, including, without limitation, failure of the API or Recro Product incorporating such quantity of API to meet Agreed Quality; or THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(ii) the negligence, recklessness or willful misconduct of, or a breach of a statutory duty by, Supplier and its respective Affiliates or agents.
(c) For purposes of this Agreement, such costs shall include the expenses of notification and destruction or return of the recalled or withdrawn API or Recro Product and all other documented out-of-pocket costs incurred in connection with such Recall but shall not include lost profits or opportunity costs of either Party. If Supplier is responsible for the Recall as set out above, Supplier shall also provide replacement API and/or reimburse Customer for costs as provided in Section 3.9. Any disputes between the Parties regarding responsibility for Recall costs shall be resolved in accordance with Section 12.15.
Responsibility for Recall Costs. “Recall Costs” shall mean all reasonable direct, documented out-of-pocket costs associated with a Recall including the expenses of notifications and investigations, and destruction or return of the Product subject to the Recall and any costs associated with the distribution of the replacement Product. Recall Costs will be (a) the responsibility of [***], or (b) [***]; provided, however, that [***].
