Clinical Quality Agreement. Within [*] days from the Effective Date of this Agreement, the Parties shall enter into a quality agreement that shall address and govern issues related to the quality of clinical Compounds to be supplied by the Parties for use in the Study (“Clinical Quality Agreement”). The Clinical Quality Agreement shall, among other things: (i) detail classification of any Compound found to have a Non-Conformance; (ii) include criteria for Manufacturer’s Release and related certificates and documentation; (iii) include criteria and timeframes for acceptance of Merck Compound; (iv) include procedures for the resolution of disputes regarding any Compounds found to have a Non-Conformance; and (v) include provisions governing the recall of Compounds.
Appears in 3 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.), Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.), Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.)