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
Appears in 2 contracts
Samples: Note Purchase Agreement (RVL Pharmaceuticals PLC), Note Purchase Agreement (Osmotica Pharmaceuticals PLC)
Material Products. If any of the following occurs: (i) The the FDA shall revoke, withdraw, suspend, cancel, materially adversely limit, terminate or materially adversely modify any approved Key Required 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 Required 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 fiscal quarters immediately following such Non-FDA Governmental Action by comparing Consolidated Revenues for the four Fiscal Quarter fiscal quarter period most recently ended prior to such Non-FDA Governmental Action for which the Issuer Borrower was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter 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 fiscal quarters immediately following the issuance or initiation of such Safety Notice by comparing Consolidated Revenues for the four Fiscal Quarter fiscal quarter period most recently ended prior to the issuance or initiation of such Safety Notice for which the Issuer Borrower was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter fiscal quarter period ending on the applicable date of assessment; or;
Appears in 2 contracts
Samples: Credit Agreement (Biocryst Pharmaceuticals Inc), Credit Agreement (Biocryst Pharmaceuticals Inc)
Material Products. (i) The FDA shall revoke, withdraw, suspend, cancel, materially adversely 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 twenty-five percent (1025%), as assessed as at the end of each of the four Fiscal Quarters fiscal quarters immediately following such Non-FDA Governmental Action by comparing Consolidated Revenues for the four Fiscal Quarter fiscal quarter period most recently ended prior to such Non-FDA Governmental Action for which the Issuer Borrower was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter 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 twenty-five percent (1025%), as assessed as at the end of each of the four Fiscal Quarters fiscal quarters immediately following the issuance or initiation of such Safety Notice by comparing Consolidated Revenues for the four Fiscal Quarter fiscal quarter period most recently ended prior to the issuance or initiation of such Safety Notice for which the Issuer Borrower was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter fiscal quarter period ending on the applicable date of assessment; or
Appears in 2 contracts
Samples: Credit Agreement (Dermira, Inc.), Credit Agreement (Kala Pharmaceuticals, Inc.)
Material Products. At any time, (i) The the FDA shall revoke, withdraw, suspend, cancel, materially limit, terminate or materially adversely modify any approved Key Required Permit related to any Material 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 Required Permit related to any Material material Product (in each case, a “Non-FDA Governmental Action”) and, in any such case, Consolidated Revenues shall decrease by greater than ten twenty percent (1020%), as assessed as at the end of each of the four Fiscal Quarters fiscal quarters immediately following such Non-FDA Governmental Action by comparing Consolidated Revenues for the four Fiscal Quarter fiscal quarter period most recently ended prior to such Non-FDA Governmental Action for which the Issuer was Loan Parties were required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter 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 material Product after approval by the FDA or any other Governmental Authority and Consolidated Revenues shall decrease by greater than ten twenty percent (1020%), as assessed as at the end of each of the four Fiscal Quarters fiscal quarters immediately following the issuance or initiation of such Safety Notice by comparing Consolidated Revenues for the four Fiscal Quarter fiscal quarter period most recently ended prior to the issuance or initiation of such Safety Notice for which the Issuer was Loan Parties were required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter fiscal quarter period ending on the applicable date of assessment; or
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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 twenty-five percent (1025%), as assessed as at the end of each of the four Fiscal Quarters fiscal quarters immediately following such Non-FDA Governmental Action by comparing Consolidated Revenues for the four Fiscal Quarter fiscal quarter period most recently ended prior to such Non-FDA Governmental Action for which the Issuer was Loan Parties were required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter 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 twenty-five percent (1025%), as assessed as at the end of each of the four Fiscal Quarters fiscal quarters immediately following the issuance or initiation of such Safety Notice by comparing Consolidated Revenues for the four Fiscal Quarter fiscal quarter period most recently ended prior to the issuance or initiation of such Safety Notice for which the Issuer was Loan Parties were required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter fiscal quarter period ending on the applicable date of assessment; provided, however, that, any event, occurrence, fact, condition or change, directly or indirectly, arising out of or attributable to the KP1077 Phase 2 Trial or the non-occurrence of the Arimoclomol FDA Approval, in each case, shall not give rise to an Event of Default under this Section 9.01(o); or
Appears in 1 contract
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 Borrower 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 Borrower 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
Appears in 1 contract
Samples: Term Loan Credit Agreement (RVL Pharmaceuticals PLC)
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 twenty percent (1020%), as assessed as at the end of each of the four Fiscal Quarters fiscal quarters immediately following such Non-FDA Governmental Action by comparing Consolidated Revenues for the four Fiscal Quarter 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 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 twenty percent (1020%), as assessed as at the end of each of the four Fiscal Quarters fiscal quarters immediately following the issuance or initiation of such Safety Notice by comparing Consolidated Revenues for the four Fiscal Quarter 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 fiscal quarter period ending on the applicable date of assessment; or
Appears in 1 contract
