Suspension of Clinical Development Activities. Any Party shall have the right to immediately suspend the relevant clinical development activities with respect to a Product or Compound for a particular indication, formulation or dosage form in the event that such Party, in good faith, determines that there exists significant and urgent concerns relating to patient safety with respect to such clinical studies. The Party making the determination to suspend such clinical activities shall notify the other Parties in writing immediately of any such suspension and the reasons therefor. The PDC shall then promptly determine what actions should be taken with respect to such clinical activities. Once a determination is made by the PDC with respect to the appropriate actions to be taken, the PDC shall review and re-evaluate the relevant Clinical Development Plan and the Clinical Budget and make any changes necessary to implement such actions.
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Samples: Development, Promotion, Distribution and Supply Agreement, Development, Promotion, Distribution and Supply Agreement (Bristol Myers Squibb Co), Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc/De)