Common use of Stability Studies and Protocol Clause in Contracts

Stability Studies and Protocol. The Client will develop and validate stability indicating assay(s) before process validation. If required, Patheon may assist at Client’s cost. If applicable, Patheon will conduct stability studies in accordance with the agreed and validated stability testing analytical methods at the agreed upon testing points in accordance with the approved stability protocol. Patheon will perform the stability testing described in a stability protocol agreed to by both Patheon and the Client. Patheon will give the Client the stability data on an ongoing basis as agreed to by both parties.

Appears in 3 contracts

Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC), Product Agreement (Horizon Pharma, Inc.)

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Stability Studies and Protocol. The Client will develop and validate stability indicating assay(s) before prior to process validation. If required, Patheon may assist at Client’s costwith [***]. If applicable, Patheon will conduct stability studies in accordance with the agreed and validated stability testing analytical methods at the agreed upon testing points in accordance with the approved stability protocol. Patheon will perform the stability testing described in a stability protocol agreed to by both Patheon and the Client. Stability data will be provided by Patheon will give to the Client the stability data on an ongoing basis as agreed to by both parties.

Appears in 2 contracts

Samples: Supply Agreement (Relypsa Inc), Supply Agreement (Relypsa Inc)

Stability Studies and Protocol. The Client will develop and validate stability indicating assay(s) before prior to process validation. If required, Patheon may assist at with the cost being borne by the Client’s cost. If applicable, Patheon will conduct stability studies in accordance with the agreed and validated stability testing analytical methods at the agreed upon testing points in accordance with the approved stability protocol. Patheon will perform the stability testing described in a stability protocol agreed to by both Patheon and the Client. Stability data will be provided by Patheon will give to the Client the stability data on an ongoing basis as agreed to by both parties.

Appears in 1 contract

Samples: Avanir Pharmaceuticals, Inc.

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Stability Studies and Protocol. The Client will develop and validate stability indicating assay(s) before process validation. If required, Patheon may assist at Client’s costcost at Client’s written request. If applicable, Patheon will conduct stability studies in accordance with the agreed and validated stability testing analytical methods at the agreed upon testing points in accordance with the approved stability protocol. Patheon will perform the stability testing described in a stability protocol agreed to by both Patheon and the Client. Patheon will give the Client the stability data on an ongoing basis as agreed to by both parties.

Appears in 1 contract

Samples: Quality Agreement (Jaguar Animal Health, Inc.)

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