Common use of Stability Testing Clause in Contracts

Stability Testing. If applicable, Patheon 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, 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 withthe Specifications and cGMP. Patheon will retain all stability test data and 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. If applicable, Patheon will 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, cGMPs, and cGMPApplicable Laws. Patheon will retain all give Client ail stability test data and will provide such data to Client 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. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, cGMPs, Applicable Laws, and cGMPother requirements specified herein. Patheon will retain give Client all stability test data and will provide such data to Client 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. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, cGMPs, and cGMPApplicable Laws. Patheon will retain give Client all stability test data and will provide such data to Client 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. If applicable, Patheon 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, reasonably and in good faith, 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 withthe with the Specifications and cGMPcGMPs. Patheon will retain Client shall own all stability test data and results and Patheon will provide such give Client all stability test data to Client 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. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications and cGMPwith the Manufacturing Requirements. Patheon will retain give Client all stability test data and will provide such data to Client results at Client’s request.

Appears in 2 contracts

Sources: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)

Stability Testing. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, cGMPs, and cGMPApplicable Laws. Patheon will retain give Client all stability test data and will provide such data to Client 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. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, cGMPs, and cGMPApplicable Laws. Patheon will retain give Client all stability test data and will provide such data to Client 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. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, Applicable Laws, the Quality Agreement and cGMPcGMPs. Patheon will retain give Client all stability test data and will provide such data to Client results at Client’s request.

Appears in 1 contract

Sources: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)

Stability Testing. If applicable, Patheon 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, reasonably jointly and in good faith, 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 withthe with the Specifications and cGMPcGMPs. Patheon will retain give Client all stability test data and will provide such data to Client results at Client’s request.

Appears in 1 contract

Sources: Master Manufacturing Services Agreement (TESARO, Inc.)

Stability Testing. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, cGMPs, and cGMPApplicable Laws. Patheon will retain give Client copies of all stability test data and will provide such data to Client results at Client’s request.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Pozen Inc /Nc)

Stability Testing. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, cGMPs, and cGMPApplicable Laws. Patheon will retain give Client all stability test data and will provide such data to Client results at Client’s 's request.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Egalet Corp)

Stability Testing. If applicable, Patheon 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, reasonably and in good faith, 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 withthe Specifications with the Specifications, cGMPs, and cGMPApplicable Laws. Patheon will retain give Client all stability test data and will provide such data to Client results at Client’s 's request.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Horizon Pharma PLC)

Stability Testing. If applicable, Patheon will conduct stability testing on the Products as part of the Manufacturing Services provided hereunder. Patheon will perform such testing 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 AgreementC, if applicable. 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, reasonably and in good faith, 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 withthe Specifications and cGMPwith the Specifications, cGMPs, or Applicable Laws. Patheon will retain give Client all stability test data and will provide such data to Client results (including a final approved report) at Client’s requestrequest and promptly upon completion of such testing.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Optimer Pharmaceuticals Inc)