Common use of Material Products Clause in Contracts

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 Net Product Sales shall decrease by greater than [***] percent ([***]%), as assessed as at the end of each of the four fiscal quarters immediately following such Non-FDA Governmental Action, in each case, by comparing Consolidated Net Product Sales for such fiscal quarter against Consolidated Net Product Sales for the corresponding fiscal quarter of the prior fiscal year of the Issuer; or (iii) 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 Net Product Sales shall decrease by greater than [***] percent ([***]%), as assessed as at the end of each of the four fiscal quarters immediately following the issuance or initiation of such Safety Notice, in each case, by comparing Consolidated Net Product Sales for such fiscal quarter against Consolidated Net Product Sales for the corresponding fiscal quarter of the prior fiscal year of the Issuer; or

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 Net Product Sales shall decrease by greater than [***] percent ([***]%), as assessed as at the end of each of the four fiscal quarters immediately following such Non-FDA Governmental Action, in each case, by comparing Consolidated Net Product Sales for such fiscal quarter against Consolidated Net Product Sales for the corresponding fiscal quarter of the prior fiscal year of the Issuer; or (iii) 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 Net Product Sales shall decrease by greater than [***] percent ([***]%), as assessed as at the end of each of the four fiscal quarters immediately following the issuance or initiation of such Safety Notice, in each case, by comparing Consolidated Net Product Sales for such fiscal quarter against Consolidated Net Product Sales for the corresponding fiscal quarter of the prior fiscal year of the Issuer; oror (o)