Definition of Post-Approval Study

  1. Post-Approval Study means any Phase 4 Study that is not required by the applicable Regulatory Authorities, such as any studies conducted in support of pricing or reimbursement for the Licensed Product (such as health economic studies, epidemiological studies, modeling and pharmacoeconomic studies), post-marketing surveillance studies, investigator sponsored studies and health economics studies.

Definition of Post-Approval Study in Collaboration and License Agreement

Post-Approval Study means any Phase 4 Study that is not required by the applicable Regulatory Authorities, such as any studies conducted in support of pricing or reimbursement for the Licensed Product (such as health economic studies, epidemiological studies, modeling and pharmacoeconomic studies), post-marketing surveillance studies, investigator sponsored studies and health economics studies.


Definition of Post-Approval Study in License and Collaboration Agreement

Post-Approval Study means a non-human or human clinical study of a product initiated after receipt of Regulatory Approval for such product in a country or territory. 1.74.


Definition of Post-Approval Study in License Agreement

Post-Approval Study means a clinical study of Licensed Product Initiated after receipt of Regulatory Approval for a Licensed Product in the China Company Territory.