FDA Approval Date

FDA Approval Date. Means the date that Collegium receives final notice from the FDA that the Product can be sold in the Territory.

FDA Approval Date. The earlier of: (i) the date on which a Project Catheter receives approval for marketing or selling from the United States Food and Drug Administration or any successor agency; (ii) the date on which Spectranetics or anyone on its behalf commences marketing a Project Catheter in the United States; (iii) the date on which Spectranetics or anyone on its behalf completes the first commercial sale of any Project Catheter in the United States; or (iv) the date on which Spectranetics or anyone on its... behalf accomplishes sales of Project Catheters outside the United States for an amount equal to $5 million in the aggregate in the preceding 12-month period View More