Common use of Manufacturing Process Clause in Contracts

Manufacturing Process. If any process event occurs during the manufacturing of any Finished Product, which event is likely materially to affect the safety, efficacy or regulatory status of the Finished Product, then Patheon shall promptly notify Santarus. Further, Patheon shall fully and appropriately investigate and report to Santarus on all complaints and notices of quality issues concerning the Finished Products from the FDA, any Foreign Regulatory Authority or Government Authority of which Santarus shall have given Patheon notice. Santarus and Patheon shall consult with each other as to the disposition of all affected batches of such Finished Product. Patheon shall report to Santarus in writing any other atypical process event that is unlikely to materially affect the safety, efficacy or regulatory status of the Finished Product within a reasonable time after occurrence. No Bulk API or Finished Product may be reprocessed without the prior written consent of Santarus.

Manufacturing Process. If any process event occurs during the manufacturing of any Finished Product, which event is likely materially to affect the safety, efficacy or regulatory status of the Finished Product, then Patheon Manufacturer shall promptly notify Santarus. Further, Patheon Manufacturer shall fully and appropriately investigate and report to Santarus on all complaints and notices of quality issues concerning the Finished Products from the FDA, any Foreign Regulatory Authority or Government Authority of which Santarus shall have given Patheon Manufacturer notice. Santarus and Patheon Manufacturer shall consult with each other as to the disposition of all affected batches of such Finished Product. Patheon Manufacturer shall report to Santarus in writing any other atypical process event that is unlikely to materially affect the safety, efficacy or regulatory status of the Finished Product within a reasonable time after occurrence. No Bulk API or Finished Product may be reprocessed without the prior written consent of Santarus.

Manufacturing Process. If any process event occurs during the manufacturing of any Finished Product, which event is likely materially to affect the safety, efficacy or regulatory status of the Finished Product, then Patheon shall promptly notify Santarus. Further, Patheon shall fully and appropriately investigate and report to Santarus on all complaints and notices of quality issues concerning the Finished Products from the FDA, any Foreign Regulatory Authority or Government Authority of which Santarus shall have given Patheon notice. Santarus and Patheon shall consult with each other as to the disposition of all affected batches of such Finished Product. Patheon shall report to Santarus in writing any other atypical process event that is unlikely to materially affect the safety, efficacy or regulatory status of the Finished Product within a reasonable time after occurrence. No Bulk API OME or Finished Product may be reprocessed without the prior written consent of Santarus.