Patheon Responsibility Clause Samples

Patheon Responsibility. In the event the Client rejects Product in accordance with this Section 6.1, and the deviation is determined to arise from Patheon’s failure to provide the Manufacturing Services in accordance with Specifications or cGMPs, Patheon will credit the Client’s account for Patheon’s invoice price to the Client for such defective Product. If the Client shall have previously paid for such defective Product, Patheon shall promptly, at the Client’s election, either: (i) refund the invoice price for such defective Product; (ii) offset such amount against other amounts due to Patheon hereunder; or (iii) replace such Product with conforming Product without the Client being liable for payment therefor under Section 3.1, contingent upon the receipt from the Client of all Active Material required for the manufacture of such replacement Product. Subject to the conditions and limitations set out in Section 10.2, Patheon shall be responsible for paying for any Active Material used for the rejected Product under this Section 6.1(c).

Patheon Responsibility. In the event Santarus rejects Finished Products in accordance with this Section 3.5 and the rejected Finished Product is determined not to conform to the Patheon Manufacturing Responsibilities, Patheon will credit Santarus' account for Patheon's invoice price to Santarus for such non-conforming Finished Products. If Santarus *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. shall have previously paid for such defective Finished Products, Patheon shall promptly, at Santarus' election, either: (i) refund the invoice price for such defective Finished Products; (ii) offset such amount against other amounts due to Patheon hereunder; or (iii) replace such Finished Products with conforming Finished Products as soon as reasonably possible without Santarus being liable for payment therefor under Section 6.3, contingent upon the receipt from Santarus of all API required for the manufacture of such replacement Finished Products. Further, Patheon shall reimburse Santarus for all reasonable shipping, handling and storage charges incurred in association with such non-conforming Finished Product and for the Bulk API utilized in such non-conforming Finished Product in accordance with Section 2.10. Nothing in this Section 3.5.3 shall be construed to limit the rights and remedies available to Santarus at law or in equity.

Patheon Responsibility. In the event the Client rejects Products in accordance with this Section 6.1 and the deviation is determined to arise from Patheon's failure to provide the Manufacturing Services in accordance with the Specifications and cGMPs, Patheon will credit the Client's account for Patheon's invoice price to the Client for such defective Products. -17- <PAGE> If the Client shall have previously paid for such defective Products, Patheon shall promptly, at the Client's election, either: (i) refund the invoice price for such defective Products; (ii) offset such amount against other amounts due to Patheon hereunder; or (iii) replace such Products with conforming Products without the Client being liable for payment therefor under Section 3.1, contingent upon the receipt from the Client of all Active Material required for the manufacture of such replacement Products. Subject to the limitations set out in Section 10.2, Patheon shall be responsible for paying for any Active Material needed under this Section 6.1(c) in accordance with the procedures set forth in Section 2.3 hereof. Further, if it is determined that there is a deviation with any part of the shipment of Product, at the Client's option, Patheon will take receipt of such shipment and perform an inspection of 100% of the Product in the shipment. The parties acknowledge that time is of the essence in meeting their obligations under this Section 6.1(c).

Patheon Responsibility. To the extent that a recall or return results from, or arises out of, a failure by Patheon to perform in accordance with this Agreement or to provide the Manufacturing Services in accordance with the 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. 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 Patheon shall 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 Responsibility. Except as otherwise provided in this Agreement or the applicable Product Agreement or as required to address any cGMP deficiencies attributable to Patheon or its agents, Patheon’s obligations for the accuracy or cost of any application for Regulatory Approval of the Product will be limited to [***].

Patheon Responsibility. In the event New River rejects Products in accordance with this Section 6.1, and the deviation is determined to arise from Patheon’s failure to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon will credit New River’s account for Patheon’s invoice price to New River for such defective Products. If New River shall have previously paid for such defective Products, Patheon shall promptly, at New River’s election, either: (i) refund the invoice price for such defective Products; (ii) offset such amount against other amounts due to Patheon hereunder; or (iii) replace such Products with conforming Products [***] without New River being liable for payment therefor under Section 3.1, 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. In any case in which New River rejects Products in accordance with this Section 6.1, Patheon shall, subject to the provisions of Section 2.4, reimburse New River for all costs incurred by New River with respect to Active Materials used in such non-compliant Products.

Patheon Responsibility. In the event the Client rejects Products in accordance with this Section 6.1 and the deviation is determined to arise from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications or cGMPs, Patheon will, at the Client’s election, either: (i) credit the Client’s account for Patheon’s invoice price to the Client for such defective Products or (ii) use its commercially reasonable efforts to replace such Products with conforming Products within [***] days’ of the Client’s rejection of the non-conforming Products; provided, however, that Patheon shall [***]. If the Client shall have previously paid for such defective Products, Patheon shall, at the Client’s election, either: (i) refund the invoice price for such defective Products within [***] days’ of the Client’s rejection of the non-conforming Products; (ii) offset such amount against other amounts due to Patheon hereunder; or (iii) use its commercially reasonable efforts to replace such Products with conforming Products within [***] days’ of the Client’s rejection of the non-conforming Products without the Client being liable for payment therefor under Section 3.1. In connection with the production of any replacement Products under this Section 6.1(c), Patheon’s cost for the procurement of any additional [***] required for the manufacture of such replacement Products shall be limited to the [***]. Nothing in this Section 6.1 shall be construed to limit the rights and remedies available to the Client at law or in equity.