Common use of Stability Testing Clause in Contracts

Stability Testing. Patheon shall conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees specified in Schedule C. Patheon shall not make any changes to these testing protocols without prior written approval from the Client. In the event that any batch of Products fails stability testing, Patheon and the Client shall jointly determine the proceedings and methods to be undertaken to investigate the causes of such failure, including which party shall bear the cost of such investigation, provided that Patheon shall not be liable for any such costs unless there has been a failure by it to provide the Manufacturing Services in accordance with the Specifications and cGMPs. Patheon will provide any and all data and results relating to the stability testing upon request by the Client.

Appears in 3 contracts

Sources: Manufacturing Services Agreement, Manufacturing Services Agreement (Critical Therapeutics Inc), Manufacturing Services Agreement (Critical Therapeutics Inc)

Stability Testing. Patheon shall will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees specified and during the time periods set out in Schedule C. Patheon shall will not make any changes to these testing protocols without prior written approval from the Client. In the event that any batch of Products fails If a confirmed stability testingtest failure occurs, Patheon will notify Client within [***], after which Patheon and the Client shall will jointly determine the proceedings and methods to be undertaken to investigate the causes cause of such the failure, including which party shall will bear the cost of such the investigation, provided that . Patheon shall will not be liable for any such these costs unless there it has been a failure by it failed to provide perform the Manufacturing Services in accordance with the Specifications and cGMPs. Patheon will provide any and give Client all stability test data and results relating to the stability testing upon request by the 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 shall will conduct stability testing on the Products Product in accordance with the protocols set out in the Specifications for the separate fees specified and during the time periods set out in Schedule C. Patheon shall will not make any changes to these testing protocols without prior written approval from the Client. In the event that any batch of Products fails If a confirmed stability testingtest failure occurs, Patheon will notify Client within [**], after which Patheon and the Client shall will jointly determine the proceedings and methods to be undertaken to investigate the causes cause of such the failure, including which party shall will bear the cost of such the investigation, provided that . Patheon shall will not be liable for any such these costs unless there it has been a failure by it failed to provide perform the Manufacturing Services in accordance with the Specifications and cGMPs. Patheon will provide any and give Client all stability test data and results relating to the stability testing upon request by the at Client’s request.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Nabriva Therapeutics PLC)

Stability Testing. If applicable, Patheon shall conduct stability testing on the Products in accordance with the protocols set out in the Specifications Schedule C for the separate fees specified in Schedule C. Patheon shall not make any changes to these testing protocols without prior written approval from the Client. In the event that any batch of Products fails a confirmed stability testingtest failure, Patheon will notify the Client within ****, after which Patheon and the Client shall jointly determine the proceedings and methods to be undertaken to investigate the causes of such failure, including which party shall bear the cost of such investigation, provided that Patheon shall not be liable for any such costs unless there has been a failure by it to provide the Manufacturing Services in accordance with the Specifications and cGMPs****. Patheon will promptly provide any and all data and results relating to the stability testing upon request by the Client.

Appears in 1 contract

Sources: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)

Stability Testing. Patheon shall conduct stability testing on the Products in accordance with the protocols set out in the Specifications Schedule C for the separate fees specified in Schedule C. Patheon shall not make any changes to these testing protocols without prior written approval from the Client. In the event that any batch of Products fails a confirmed stability testingtest failure, Patheon will notify the Client within ****, after which Patheon and the Client shall jointly determine the proceedings and methods to be undertaken to investigate the causes of such failure, including which party shall bear the cost of such investigation, provided that Patheon shall not be liable for any such costs unless there has been a failure by it to provide the Manufacturing Services in accordance with the Specifications and cGMPs; ****. Patheon will promptly provide any and all data and results relating to the stability testing upon request by the Client.

Appears in 1 contract

Sources: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)