Common use of Stability Testing Clause in Contracts

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: Product Agreement (Osmotica Pharmaceuticals PLC), Product Agreement (Osmotica Pharmaceuticals LTD), Product Agreement (Osmotica Pharmaceuticals LTD)

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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: Product 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 Master Manufacturing Services Agreement 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: Product Agreement (La Jolla Pharmaceutical Co), Product 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. 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: Product Agreement (Horizon Pharma, Inc.), Product 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

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, Specifications and cGMPs, and Applicable Laws. Patheon will give Client ail all stability test data and results at Client’s request.

Appears in 2 contracts

Samples: Services Agreement (Evoke Pharma Inc), 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 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. 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 2 contracts

Samples: Master Manufacturing Services Agreement, Product 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 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: Product 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

Samples: Manufacturing Services Agreement (Egalet Corp)

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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 ***Confidential Treatment Requested 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 ***Confidential Treatment Requested Standard Form (PPI, April 2, 2010) 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 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 [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED Standard Form (PPI, April 2, 2010) 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 1 contract

Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)

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.. Manufacturing Services Agreement

Appears in 1 contract

Samples: 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 Master Manufacturing Services Agreement 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/)

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)

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