Material Products Sample Clauses

Material Products. (i) The FDA shall revoke, withdraw, suspend, cancel, materially limit, terminate or materially adversely modify any approved Key Permit related to any Material Product; or (ii) any Governmental Authority (other than the FDA) shall revoke, withdraw, suspend, cancel, materially limit, terminate or materially modify any approved Key Permit related to any Material Product (in each case, a “Non-FDA Governmental Action”) and, in any such case, Consolidated Revenues shall decrease by greater than ten percent (10%), as assessed as at the end of each of the four Fiscal Quarters immediately following such Non-FDA Governmental Action by comparing Consolidated Revenues for the four Fiscal Quarter period most recently ended prior to such Non-FDA Governmental Action for which the Issuer was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter period ending on the applicable date of assessment; or (iii) subject to Section 9.01(p), any Safety Notice is issued or initiated in connection with any Material Product after approval by the FDA or any other Governmental Authority and Consolidated Revenues shall decrease by greater than ten percent (10%), as assessed as at the end of each of the four Fiscal Quarters immediately following the issuance or initiation of such Safety Notice by comparing Consolidated Revenues for the four Fiscal Quarter period most recently ended prior to the issuance or initiation of such Safety Notice for which the Issuer was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter period ending on the applicable date of assessment; or