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
Samples: 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 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
Samples: Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma 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
Samples: 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. 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
Samples: 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 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
Samples: 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 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
Samples: 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 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
Samples: 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 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
Samples: 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 request.
Appears in 2 contracts
Samples: 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 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
Samples: 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. 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
Samples: 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 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
Samples: Master Manufacturing Services Agreement (TESARO, Inc.)
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 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
Samples: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)