Governmental Approvals; FDA Action. (a) Any Governmental Approval shall have been revoked, rescinded, suspended, modified in an adverse manner, or not renewed in the ordinary course for a full term and such revocation, rescission, suspension, modification or non‑renewal has resulted in or could reasonably be expected to result in a Material Adverse Change; or (b) (i) the FDA, DOJ or other Governmental Authority initiates a Regulatory Action or any other enforcement action against Borrower or any of its Subsidiaries or any supplier of Borrower or any of its Subsidiaries that causes Borrower or any of its Subsidiaries to recall, withdraw, remove or discontinue manufacturing, distributing, and/or marketing any of its products, even if such action is based on previously disclosed conduct, which Regulatory Action or other enforcement action results in a decrease of 5% or more in total revenues (under GAAP) from the sale in the ordinary course of business to third party customers of ILUVIEN or any other products at the end of each month for the six months following the occurrence of such Regulatory Action or other enforcement action, measured on a trailing three (3) month basis, compared to the trailing three (3) month revenue as measured on the month end immediately prior to the occurrence of such Regulatory Action or other enforcement action and each month end during such six (6) month period (with each period being adjusted for customary seasonality, if applicable, solely in a manner consistent with documented seasonality for such revenues from the same period in the immediately prior fiscal year of Borrower); (ii) the FDA issues a warning letter to Borrower or any of its Subsidiaries with respect to any of its activities or products which could reasonably be expected to result in a Material Adverse Change; (iii) Borrower or any of its Subsidiaries conducts a mandatory or voluntary recall which could reasonably be expected to result in liability and expense to Borrower or any of its Subsidiaries of Five Hundred Thousand Dollars ($500,000) or more and such recall has resulted in a decrease of 5% or more in total revenues (under GAAP) from the sale in the ordinary course of business to third party customers of ILUVIEN or any other products at the end of each month for the six months following the occurrence of such recall, measured on a trailing three (3) month basis, compared to the trailing three (3) month revenue as measured on the month end immediately prior to the occurrence of such recall a...
Governmental Approvals; FDA Action. Any Governmental Approval shall have been revoked, rescinded, suspended, modified in an adverse manner, or not renewed in the ordinary course for a full term and such revocation, rescission, suspension, modification or non-renewal has resulted in or could reasonably be expected to result in a Material Adverse Change.
