Patheon’s Responsibility. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon shall be responsible for the documented out-of- pocket expenses of such Recall or return and shall use its commercially reasonable efforts to replace the Recalled or returned Drug Product with new Drug Product, contingent upon the receipt from the Client of all Granulations (which shall be paid for by Patheon, subject to the limitations set out in herein) required for the manufacture of such replacement Drug Product. In the event that Patheon is unable to replace the Recalled or returned Drug Product (except where such inability results from a failure to receive the required Granulations), then the Client may request Patheon to reimburse the Client for: (i) the price that the Client paid to Patheon for manufacturing the affected Drug Product; and (ii) the cost of the Granulations. In all other circumstances, Recalls, returns or other corrective actions shall be made at the Client’s cost and expense. Patheon’s maximum liability associated with any Recall or return of a Drug Product shall be $5,000,000 per Recall or return event.
Patheon’s Responsibility. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Specifications and cGMPs, Patheon shall be responsible for the documented out-of-pocket expenses of such Recall or return and shall [ * ] to replace the Recalled or returned Product with new Product, contingent upon the receipt of all Active Materials required for the manufacture of such replacement Product. In the event that Patheon is unable to replace the Recalled or returned Product (except where such inability results from a failure to receive the required Active Materials due to the fault of Client), then at Client’s request, Patheon will reimburse the Client for the price that the Client paid to Patheon for manufacturing the affected Product. In either case, subject to the conditions and limitations set out in Section 10.2, Patheon shall pay all costs related to the Active Materials required for the manufacture of replacement Product. In all other circumstances, Recalls, returns or other corrective actions shall be made at the Client's cost and expense.
Patheon’s Responsibility. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Specifications and cGMPs, at Client's option, Patheon shall be responsible for the documented out-of-pocket expenses of such Recall or return and shall either (i) reimburse the Client for the price that the Client paid to Patheon for manufacturing the Recalled Products or (ii) use its commercially reasonable efforts to replace the Recalled or returned Products with new Products at no charge to the Client, contingent upon the receipt from the Client of all Active Material required for the manufacture of such replacement Products. If Client elects to have the Recalled Product replaced, subject to the limitations set out in Section 10.2, Patheon shall pay all costs related to the Active Material required for the manufacture of replacement Products in accordance with the procedures set forth in Section 2.3 hereof. In all other circumstances, Recalls, returns or other corrective actions shall be made at the Client's cost and expense. The parties acknowledge that time is of the essence in meeting their obligations under this Section 6.2(d).
Patheon’s Responsibility. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Specifications or cGMPs, Patheon shall be responsible for the documented out-of-pocket expenses of such Recall or return and shall promptly, at the Client’s election, either: (i) refund the invoice price for such Recalled or returned Products; (ii) offset such amount against other amounts due to Patheon hereunder; or (iii) use its commercially reasonable efforts to replace such Recalled or returned Products with conforming Products within [***] days’ of the Client’s election under this clause (d) without the Client being liable for payment therefor under Section 3.1; provided, however, that Patheon shall [***]. In all other circumstances, Recalls, returns or other corrective actions shall be made at the Client’s direction and cost and expense. In connection with the production of any replacement Products under this clause (d), Patheon’s cost for the procurement of any additional [***] required for the manufacture of such replacement Products shall be limited to the [***].
Patheon’s Responsibility. To the extent that a recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, such recall or return shall be made at Patheon’s cost and expense, and Patheon shall use commercially reasonable efforts to replace the recalled or returned Products with new Products within [**] days from the date that Sepracor definitively notifies Patheon about the recalled or returned Products, contingent upon the receipt or availability from Sepracor of all API. Patheon’s cost for such API shall be determined in accordance with Section 2.3 hereof. In the event that Patheon is unable to replace the recalled Products within this [**]-day period (except where such inability results from a failure to receive the required API), then Sepracor may request Patheon to reimburse Sepracor for the price that Sepracor paid to Patheon for manufacturing the affected Products. In all other circumstances, recalls, returns or other corrective actions shall be made at Sepracor’s cost and expense.
Patheon’s Responsibility. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon shall be responsible to New River for New River’s documented out of pocket expenses of such Recall or return. Patheon shall promptly, at New River’s election, either: (i) refund the invoice price for such Recalled or returned Products; (ii) offset such amount against other amounts due to Patheon hereunder or (iii) use [***] to replace the Recalled or returned Products with new Products [***], contingent upon the receipt from New River of all Active Materials and subject to the availability of Components required for the manufacture of such replacement Products. Subject to the limitations set out in Section 10.2, [***]. In all other circumstances, [***].
Patheon’s Responsibility. To the extent that a recall or return results from, or arises out of, a failure by Patheon to manufacture the Products in accordance with the Manufacturing Requirements, such recall or return shall be made at Patheon's cost and expense, and Patheon shall use its best efforts to replace the recalled or returned Products with new Products within 60 (sixty) days from the date that SciClone definitively notifies Patheon about the recalled or returned Products, contingent upon the receipt or availability from SciClone of all Active Pharmaceutical Ingredient. Subject to Section 10.2(b), Patheon's cost for such API shall be limited to [****] [****]
Patheon’s Responsibility. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Specifications and cGMPs, at Client's option, Patheon shall be responsible for the documented out-of-pocket expenses of such Recall or return and shall either (i) reimburse the Client for the price that the Client paid to Patheon for manufacturing the Recalled Products or (ii) use its commercially reasonable efforts to replace the Recalled or returned Products with new Products at no charge to the Client, contingent upon the receipt from the Client of all Tablet Cores required for the manufacture of such replacement Products. If Client elects to have the Recalled Product replaced, subject to the limitations set out in Section 10.2, Patheon shall pay all costs related to the Tablet Cores required for the manufacture of replacement Products in accordance with the procedures set forth in Section 2.3 hereof. In all other circumstances, Recalls, returns or other corrective actions shall be made at the Client's cost and expense. The parties acknowledge that time is of the essence in meeting their obligations under this Section 6.2(d).
Patheon’s Responsibility. To the extent that a recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, such recall or return shall be made at Patheon's cost and expense, and Patheon shall use its best efforts to replace the recalled or returned Products with new Products within 60 days from the date that Cephalon definitively notifies Patheon about the recalled or returned Products, contingent upon the receipt or availability from Cephalon of all Active Materials. Patheon's cost for such Active Materials shall be limited to the Active Materials Value thereof. In the event that Patheon is unable to replace the recalled Products within this 60-day period (except where such inability results from a failure to receive the required Active Materials), then Cephalon may request Patheon to reimburse Cephalon for the price that Cephalon paid to Patheon for manufacturing the affected Products. In all other circumstances, recalls, returns or other corrective actions shall be made at Cephalon's cost and expense.
Patheon’s Responsibility. To the extent that a recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Manufacturing Requirements, such recall or return shall be made at Patheon’s cost and expense, and Patheon shall use its commercially reasonable efforts to replace the recalled or returned Products with new Products [ ** ], contingent upon the receipt or availability from the Client of all Active Pharmaceutical Ingredient. In the event that Patheon is unable to replace the recalled Products [ ** ] (except where such inability results from a failure to receive the required Active Pharmaceutical Ingredient), then the Client may request patheon to reimburse the Client for the price that the Client paid to Patheon for manufacturing the affected Products. In all other circumstances, recalls, returns or other corrective actions shall be made at the Client’s cost and expense.
