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 2 contracts
Samples: Manufacturing Services Agreement (Critical Therapeutics Inc), Manufacturing Services Agreement (Critical Therapeutics Inc)
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.. (e)
Appears in 1 contract
Samples: Manufacturing Services Agreement
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
Samples: 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
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)