Stability Testing. Patheon may be requested to conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail stability test data and results at Client’s request.
Appears in 3 contracts
Sources: Master Manufacturing Services Agreement (Osmotica Pharmaceuticals PLC), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD)
Stability Testing. Patheon may be requested to shall conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out specified in Schedule C to a Product Agreement. C. Patheon will shall not make any changes to these testing protocols without prior written approval from the Client. If a confirmed In the event that any batch of Products fails stability test failure occurstesting, Patheon will notify and the Client within one Business Day, after which Patheon and Client will shall jointly determine the proceedings and methods to be undertaken to investigate the cause causes of the such failure, including which party will shall bear the cost of the such investigation. , provided that Patheon will shall not be liable for these any such costs unless there has been a failure by it has failed to perform provide the Manufacturing Services in accordance with the Specifications, Specifications and cGMPs, and Applicable Laws. Patheon will give Client ail stability test provide any and all data and results at relating to the stability testing upon request by the Client’s request.
Appears in 3 contracts
Sources: Manufacturing Services Agreement, Manufacturing Services Agreement (Critical Therapeutics Inc), Manufacturing Services Agreement (Critical Therapeutics Inc)
Stability Testing. If applicable, Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly jointly, reasonably and in good faith, determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, withthe Specifications and Applicable LawscGMP. Patheon will give Client ail retain all stability test data and results will provide such data to Client at Client’s request.
Appears in 3 contracts
Sources: Master Manufacturing Services Agreement, Master Manufacturing Services Agreement (Baudax Bio, Inc.), Master Manufacturing Services Agreement (Recro Pharma, Inc.)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. C. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day[***], after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, Specifications and cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 3 contracts
Sources: Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a the relevant Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, and other requirements specified herein. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 2 contracts
Sources: Master Manufacturing Services Agreement (Jaguar Animal Health, Inc.), Master Manufacturing Services Agreement (Jaguar Animal Health, Inc.)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day[**], after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services or testing in accordance with the Specifications, Specifications and cGMPs, . Client shall own all stability test data and Applicable Laws. results and Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 2 contracts
Sources: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. C. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 2 contracts
Sources: Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.), Manufacturing Services Agreement (Raptor Pharmaceutical Corp)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. C. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, . Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 2 contracts
Sources: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day[…***…], after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 2 contracts
Sources: Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products Product in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C C, subject to a Product Agreementmutual written agreement of Patheon and Client. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable LawsManufacturing Requirements. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 2 contracts
Sources: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. C. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, . Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s 's request.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Horizon Pharma PLC)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. C. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail copies of all stability test data and results at Client’s request.
Appears in 1 contract
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in In the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. C. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it It has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s 's request.
Appears in 1 contract
Stability Testing. Patheon may be requested to will conduct stability testing on the Products Product in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. C. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day[**], after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, Specifications and cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Nabriva Therapeutics PLC)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly and in good faith determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, Specifications and cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 1 contract
Sources: Master Manufacturing Services Agreement (TESARO, Inc.)
Stability Testing. If applicable, Patheon may be requested to shall conduct stability testing on the Products in accordance with the protocols set out in the Specifications Schedule C for the separate fees and during the time periods set out specified in Schedule C to a Product Agreement. C. Patheon will shall not make any changes to these testing protocols without prior written approval from the Client. If In the event of a confirmed stability test failure occursfailure, Patheon will notify the Client within one Business Day****, after which Patheon and the Client will shall jointly determine the proceedings and methods to be undertaken to investigate the cause causes of the such failure, including which party will shall bear the cost of the such investigation****. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, promptly provide any and Applicable Laws. Patheon will give Client ail stability test all data and results at relating to the stability testing upon request by the Client’s request.
Appears in 1 contract
Sources: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Stability Testing. Patheon may be requested to will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party party, in accordance with this Agreement, will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, the Quality Agreement and cGMPs. Patheon will give Client ail all stability test data and results at Client’s request.
Appears in 1 contract
Sources: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)