Approval Application

Approval Application. Means any application for Regulatory Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a pharmaceutical product in any country or jurisdiction in the Territory, including, without limitation, any NDA or MAA or any equivalent application filed with the FDA or any Foreign Regulatory Authority for Regulatory Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a pharmaceutical product in any... country or jurisdiction in the Territory. View More

Approval Application. Shall mean an application for Regulatory Approval required before commercial sale or use of the Commercial Materials in combination with any of Purchaser's Products in any applicable regulatory jurisdiction