Stability Testing. At Celator’s expense, Baxter shall perform all stability testing in compliance with the International Conference on Harmonization for Registration of Pharmaceuticals for Human Use (ICH) requirements performed on clinical, development, conformance and/or commercial Production Batches of Product. Such testing shall be performed in accordance with the procedures set out in the Product specific Xxxxxx SOPs for the stability protocol and Product Master Plan. Prior to any stability testing, Celator shall have the right to review and approve the stability testing protocol and Celator shall receive a summary report of the data generated from the stability tests. All stability data shall be forwarded to Celator within thirty (30) days of the scheduled test date.
Appears in 4 contracts
Samples: Clinical and Commercial Manufacturing and Supply Agreement, Clinical and Commercial Manufacturing and Supply Agreement (Jazz Pharmaceuticals PLC), Clinical and Commercial Manufacturing and Supply Agreement (Celator Pharmaceuticals Inc)
