Common use of Drug Application Documentation Clause in Contracts

Drug Application Documentation. Prometheus shall maintain all United States Drug Applications with respect to the Products, including, without limitation, Phase IV post approval commitments (such as Patient Surveys), semi-annual reports of FDA commitments and Adverse Event reporting and shall take all actions, pay all fees and conduct all communications with the appropriate Governmental Authority and Regulatory Authorities required by Applicable Laws in respect of each Product. For the avoidance of doubt, Prometheus shall bear all costs incurred in connection with compliance with this Section 7.3.

Appears in 5 contracts

Samples: Supply Agreement (Prometheus Laboratories Inc), Asset Purchase and Sale Agreement (Prometheus Laboratories Inc), Asset Purchase and Sale Agreement (Prometheus Laboratories Inc)

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