Recall Costs Sample Clauses

Recall Costs. Unless otherwise specified in the SOP, CollaGenex shall be responsible for conducting any Recall in the Territory and the cost and expense of a Recall shall be allocated as follows: (a) if such Recall is a voluntary Recall or shall be due to tampering or other cause, other than a manufacturer's defect, but not due to the negligence or misconduct of the Parties, or the breach by a Party of its warranties or obligations hereunder, then CollaGenex and Altana shall each bear fifty percent (50%) of the costs and expenses incurred by CollaGenex in connection with such Recall, including, without limitation, all product credits and returns, freight and shipping costs and product disposal expenses. In such event, Altana agrees to pay CollaGenex within ten (10) days after its receipt from CollaGenex of any invoice(s) assessing Altana its 50% share of these said costs, as listed above; (b) if such Recall shall be due to Manufacturing defect or the negligence or the breach by Altana of its warranties or obligations hereunder or the misconduct of Altana, all such costs and expenses shall be borne and paid solely by Altana and Altana will reimburse CollaGenex for any such costs and expenses paid by CollaGenex within ten (10) days of receipt of an invoice for such costs and expenses from CollaGenex, and if not so paid CollaGenex shall have the right to offset such amounts against amounts otherwise due by CollaGenex to Altana hereunder; and (c) if such Recall is due to the negligence or the breach by CollaGenex of its warranties or obligations hereunder or the misconduct of CollaGenex, all such costs and expenses shall be borne and paid solely by CollaGenex and CollaGenex will reimburse Altana for any such costs and expenses paid by Altana within thirty (30) days of receipt of an invoice and appropriate documentation for such costs and expenses from Altana.

Recall Costs. 49 Section 16.03. Notification of Complaints............................................50 Section 16.04. Notification of Threatened Action.....................................50 ARTICLE XVII INSURANCE..................................................................50 Section 17.01. Insurance.............................................................50 ARTICLE XVIII

Recall Costs. The costs of a recall conducted pursuant to Section 3.7 of this Agreement will be (a) the responsibility of [***], or (b) [***]; provided, however, that [***].

Recall Costs. Notwithstanding anything else contained in this Agreement to the contrary, if a Recall, Withdrawal, Field Correction or other removal of any Licensed Product or any lot or lots thereof from the market in the Licensed Territory: 7.3.3.3. and

Recall Costs. Strata shall be responsible for conducting any Recall of the Product in the Territory and the cost and expense therefor shall be paid by Strata, unless such Recall is due to, prior to or during the Development: (i) any breach by Micrologix of its representations, warranties, covenants, obligations or agreements under this Agreement; or (ii) the negligence or willful misconduct of Micrologix and/or any of Micrologix’s Representatives under this Agreement, including violation of Applicable Laws in their performance under this Agreement; in which case all such costs and expenses, to the extent same are reasonable, shall be borne and paid solely by Micrologix. In such event, Micrologix will reimburse Strata for any such costs and expenses paid by Strata within thirty (30) days of its receipt of a reasonably detailed invoice(s) for such costs and expenses from Strata.

Recall Costs. If any recall, withdrawal or seizure of any Licensed Product occurs due to (a) the failure of BioMarin to comply in any respect with any applicable law, rule, regulation, standard, court order, decree or any directive of any relevant governmental authority, (b) the failure of BioMarin to comply with any of the terms of this Agreement, or (c) an order by a government authority that a Product bearing BioMarin’s NDC must be removed from the market, then BioMarin shall bear the full cost and expense of any such recall, withdrawal or seizure, subject to any agreement BioMarin may have with a third party requiring contribution to the cost of recall. If any recall, withdrawal or seizure of any Licensed Product occurs in North America for any other reason, then Alliant shall bear the full cost and expense of any such recall, withdrawal or seizure, subject to any agreement Alliant may have, on its own or as an assignee of BioMarin’s rights, with a third party requiring contribution to the cost of recall. If both BioMarin and Alliant contribute to the cause of a seizure, recall or withdrawal of any Licensed Product, the cost and expenses thereof will be shared in proportion to each party’s contribution to the problem.

Recall Costs. Nycomed shall be responsible for conducting any Recall in the Territory and the cost and expense of a Recall shall be allocated as follows:

Recall Costs. Fujisawa shall be responsible for conducting any Recall of the Product in Field in the Territory and the cost and expense therefor shall be paid by Fujisawa, unless such Recall is due to: (i) any breach by Cardiome of its representations, warranties, covenants, obligations or agreements under this Agreement; or (ii) the negligence or willful misconduct of Cardiome or any of Cardiome’s Representatives under this Agreement, including violation of Applicable Laws in their performance under this Agreement or prior to the Development; in which case all such costs and expenses, to the extent same are reasonable, shall be borne and paid solely by Cardiome. In such event, Fujisawa shall recover any such costs and expenses paid by Fujisawa solely by deducting them from any royalty payments or any other amounts payable to Cardiome hereunder in accordance with Section 4.5.

Recall Costs. All out-of-pocket expenses for the execution of any recall or withdrawal of a Licensed Product (“Recall Costs”) pursuant to Section 14.5(a) above shall be initially borne by the [***]. In the event that it is finally determined, or agreed between the Parties, that such recall or withdrawal is caused by: (i) [***]; (ii) [***]; (iii) [***].

Recall Costs. Yakult shall bear the Recall Costs of any recall of the Licensed Product in Japan described in Section 9.1.1 and 9.1.2; provided, however, that GPC Biotech shall bear the Recall Costs of a recall to the extent that such recall reasonably resulted from GPC Biotech’s breach of its obligations hereunder or under the Quality Agreement or its negligence or willful misconduct. GPC Biotech shall bear the Recall Costs of (a) any recall of the Licensed Product in Japan described in Section 9.1.3 and (b) any recall of the Licensed Product in the GPC Biotech Territory. “Recall Costs” means all reasonable (i) internal and external costs and expenses incurred to collect Licensed Product already on the market at whatever level (e.g. from wholesalers, distributors, pharmacists, medical doctors, patients, etc.), including handling and transportation costs, (ii) costs and expenses incurred to destroy or return to GPC Biotech (or GPC Biotech’s designee) defective quantities of Licensed Product (whether still stored at Yakult’s facilities or collected from the market), (iii) costs and expenses incurred to replace all defective quantities of Licensed Product at all levels of the market and (iv) credits or reimbursements extended to customers.