Common use of FDA Approvals Clause in Contracts

FDA Approvals. To Semnur’s knowledge, it possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur nor, to ▇▇▇▇▇▇’s knowledge, any officer, employee or agent of Semnur has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (i) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entities, (ii) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, or (iii) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entities. Neither Semnur nor any of its officers, employees, or, to Semnur’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. Neither Semnur nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur nor any of its officers, employees, or to Semnur’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it (a) The Company possesses all required permits, licenses, registrations, certificates, authorizations, orders orders, exemptions, clearances and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals business as required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it . (b) The Company has not received any notice of proceedings relating to the suspension, material modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇the Company’s knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (i) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b)335a, or disqualification under any similar law, rule or regulation of any other governmental entities, (ii) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, or (iii) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entities. . (c) Neither Semnur the Company nor any of its officers, employees, or, to Semnurthe Company’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September October 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. . (d) Neither Semnur nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur Company nor any of its officers, employees, or to Semnurthe Company’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entityentity that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

FDA Approvals. To Semnur’s knowledge, it The Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇the Company’s knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entities. Neither Semnur the Company nor any of its officers, employees, or, to Semnurthe Company’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. Neither Semnur the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur the Company nor any of its officers, employees, or to Semnurthe Company’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it The Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇the Company’s knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entities. Neither Semnur the Company nor any of its officers, employees, orofficers nor , to Semnurthe Company’s knowledge, any of its employees, contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. Neither Semnur the Company nor any of its officersofficers nor, to the Company’s knowledge, any of its employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur the Company nor any of its officersofficers nor, employees, or to Semnurthe Company’s knowledge, any of its contractors employees, contractors, or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it Parent possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it Parent has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur Parent nor, to ▇▇▇▇▇▇’s knowledge, any officer, employee or agent of Semnur Parent has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (i) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entities, (ii) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, or (iii) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entities. Neither Semnur Parent nor any of its officers, employees, or, to SemnurParent’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) Policy and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. Neither Semnur Parent nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur Parent nor any of its officers, employees, or to SemnurParent’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s the Company's knowledge, it the Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA U.S. Food and Drug Administration ("FDA") or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any notice of proceedings relating to the suspension, modification, revocation revocation, or cancellation of any such permit, license, registration, certificate, authorization, order order, or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇’s the Company's knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Entities. Neither Semnur the Company nor any of its officers, employees, or, or to Semnur’s knowledgethe Knowledge of seller, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “"Fraud, Untrue Statements of Material Facts, Bribery, and Illegal illegal Gratuities” " policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “"FDA Application Integrity Policy”") and any amendments thereto, or by any other similar governmental entity Governmental Entity pursuant to any similar policy. Neither Semnur the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur the Company nor any of its officers, employees, or to Semnur’s the Company's knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledgeExcept as set forth in Subsection 2.27 of the Disclosure Schedule, it the Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA U.S. Food and Drug Administration (“FDA”) or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇the Company’s knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Entities. Neither Semnur the Company nor any of its officers, employees, or, or to Semnur’s knowledgethe Knowledge of the Company, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity Governmental Entity pursuant to any similar policy. Neither Semnur the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur the Company nor any of its officers, employees, or to Semnurthe Company’s knowledgeKnowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledgeExcept as would not be, it individually or in the aggregate, reasonably likely to have a Company Material Adverse Effect, the Company and its Subsidiaries possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it has The Company and its Subsidiaries have not received any written notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor its Subsidiaries nor, to ▇▇▇▇▇▇’s knowledgethe knowledge of the Company, any officer, employee employee, or agent of Semnur the Company or its Subsidiaries has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (ia) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Authority, (iib) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, Administration or (iiic) exclusion under 42 U.S.C. Section 1320a-7 or any similar lawLaw, rule or regulation of any governmental entitiesGovernmental Authority. Neither Semnur the Company nor any of its officersSubsidiaries, employees, ornor, to Semnur’s knowledgethe knowledge of the Company, any officer, employee, or agent of the Company its contractors or agents Subsidiaries, is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity Governmental Authority pursuant to any similar policy. Neither Semnur the Company nor its Subsidiaries, nor, to the knowledge of the Company, any officer, employee, or agent of the Company its officersSubsidiaries, employeeshas (a) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, contractors(b) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority, and agents has or (c) committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity Governmental Authority to invoke a similar policy. Neither Semnur nor any of its officers, employees, or to Semnur’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it The Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted (collectively, including all “Permits”), except where the failure to possess such permitsPermits would not, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA individually or any other federal, state or foreign agencies or bodies engaged in the regulation of drugsaggregate, pharmaceuticals, medical devices or biohazardous materialsreasonably be expected to have a Material Adverse Effect. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approvalmaterial Permit. Neither Semnur the Company nor, to ▇▇▇▇▇▇the Company’s knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entities. Neither Semnur the Company nor any of its officers, employees, or, to Semnurthe Company’s knowledge, any of its contractors or agents is the subject of any pending or or, to the Company’s knowledge, threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. Neither Semnur nor the Company nor, to the Company’s knowledge, any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur nor any of its officers, employees, or to Semnur’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it The Company possesses all material permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇’s the Company's knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Entities. Neither Semnur the Company nor any of its officers, employees, or, or to Semnur’s knowledgethe Knowledge of the Company, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. Neither Semnur the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur the Company nor any of its officers, employees, or to Semnurthe Company’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it The Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA U.S. Food and Drug Administration (“FDA”) or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any notice of proceedings relating to the suspension, material modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇the Company’s knowledgeKnowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a335a(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Authorities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Authorities. Neither Semnur nor the Company nor, to the Company’s Knowledge, any of its officers, employees, or, or to Semnur’s knowledgethe Knowledge of the Company, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity Governmental Authority pursuant to any similar policy. Neither Semnur nor the Company nor, to the Company’s Knowledge, any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity Governmental Authority to invoke a similar policy. Neither Semnur nor the Company nor, to the Company’s Knowledge, any of its officers, employees, or to Semnurthe Company’s knowledgeKnowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entityGovernmental Authority.

FDA Approvals. To Semnur’s knowledge, it The Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA U.S. Food and Drug Administration (“FDA”) or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇’s the Company's knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Entities. Neither Semnur the Company nor any of its officers, employees, or, or to Semnur’s knowledgethe Knowledge of the Company, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity Governmental Entity pursuant to any similar policy. Neither Semnur the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur the Company nor any of its officers, employees, or to Semnurthe Company’s knowledgeKnowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it Eliem possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it Eliem has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur Eliem nor, to ▇▇▇▇▇▇the Eliem’s knowledge, any officer, employee or agent of Semnur Eliem has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Entities. Neither Semnur Eliem nor any of its officers, employees, or, or to Semnur’s knowledgethe Knowledge of Eliem, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) Policy and any amendments thereto, or by any other similar governmental entity Governmental Entity pursuant to any similar policy. Neither Semnur Eliem nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur Eliem nor any of its officers, employees, or to SemnurEliem’s knowledgeKnowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it Inhibrx possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as presently conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA U.S. Food and Drug Administration (“FDA”) or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it Inhibrx has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur Inhibrx nor, to ▇▇▇▇▇▇Inhibrx’s knowledge, any officer, employee or agent of Semnur Inhibrx has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entities. Neither Semnur Inhibrx nor any of its officers, employees, or, or to Semnur’s knowledgethe knowledge of Inhibrx, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. Neither Semnur Inhibrx nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur Inhibrx nor any of its officers, employees, or to SemnurInhibrx’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledge, it Athenen possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA U.S. Food and Drug Administration (“FDA”) or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it Athenen has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur Athenen nor, to ▇▇▇▇▇▇the Athenen’s knowledge, any officer, employee or agent of Semnur Athenen has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Entities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. U. S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Entities. Neither Semnur Athenen nor any of its officers, employees, or, or to Semnur’s knowledgethe Knowledge of Athenen, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity Governmental Entity pursuant to any similar policy. Neither Semnur Athenen nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither Semnur Athenen nor any of its officers, employees, or to SemnurAthenen’s knowledgeKnowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.

FDA Approvals. To Semnur’s knowledgeExcept as would not be, it individually or in the aggregate, reasonably likely to have a Material Adverse Effect, the Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA U.S. Food and Drug Administration (“FDA”) or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company has not received any written notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company nor, to ▇▇▇▇▇▇the Company’s knowledge, any officer, employee or agent of Semnur the Company has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesAuthorities, (iiB) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, or (iiiC) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesAuthorities. Neither Semnur the Company nor to the knowledge of the Company, any of its officers, employees, or, to Semnur’s knowledge, any of its contractors or agents agents, is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity Authority pursuant to any similar policy. Neither Semnur nor the Company nor, to the Company’s knowledge, any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity Authority to invoke a similar policy. Neither Semnur the Company nor to the Company’s knowledge, any of its officers, employees, or to Semnur’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entityAuthority.

FDA Approvals. To Semnur’s knowledge, it Genezen possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals (“FDA Permits”) from the appropriate FDA or similar federal, state or foreign regulatory authorities necessary to conduct its businessbusiness as now conducted, including all such permitsexcept where failures to so comply, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA whether individually or any other federal, state or foreign agencies or bodies engaged in the regulation of drugsaggregate, pharmaceuticalswould not reasonably be expected to have a Purchaser Material Adverse Effect, medical devices or biohazardous materialstaken as a whole. To ▇▇▇▇▇▇’s knowledgeIn the past [***] years, it Genezen has not received any written notice of proceedings relating to of the suspension, material modification, revocation or cancellation of any such permitFDA Permit, licenseexcept where failures to so comply, registrationwhether individually or in the aggregate, certificatewould not reasonably be expected to have a Purchaser Material Adverse Effect, authorization, order or approvaltaken as a whole. Neither Semnur Genezen nor, to ▇▇▇▇▇▇’s knowledgethe Knowledge of Purchaser, any officer, employee or agent of Semnur Genezen has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (iA) material disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Entities, (iiB) material debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, or (iiiC) material exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Entities. Neither Semnur nor Genezen nor, to the Knowledge of Purchaser, any of its officers, employees, or, to Semnur’s knowledge, any of its contractors or agents is the subject of any pending or or, to the Knowledge of ​ ​ Purchaser, threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity Governmental Entity pursuant to any similar policy. Neither Semnur nor Genezen nor, to the Knowledge of Purchaser, any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity Governmental Entity to invoke a similar policy. Neither Semnur nor Genezen nor, to the Knowledge of Purchaser, any of its officers, employees, or to Semnur’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entityGovernmental Entity as of the date of submission, except where such notification, application, approval, report or other submission was corrected in or supplemented by a subsequent notification, application, approval, report or other submission, except where failures to so comply, whether individually or in the aggregate, would not reasonably be expected to have a Purchaser Material Adverse Effect, taken as a whole.

FDA Approvals. To Semnur’s knowledgeExcept as would not be, it individually or in the aggregate, reasonably likely to have a Material Adverse Effect, the Company Group possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its businessthe Business as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA U.S. Food and Drug Administration (“FDA”) or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. To ▇▇▇▇▇▇’s knowledge, it The Company Group has not received any written notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Semnur the Company Group nor, to ▇▇▇▇▇▇the Company Group’s knowledge, any officer, employee employee, or agent of Semnur the Company Group has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (ia) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entitiesGovernmental Authorities, (iib) debarment, suspension, or exclusion under any federal healthcare programs Federal Healthcare Programs or by the General Services Administration, Administration or (iiic) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entitiesGovernmental Authorities. Neither Semnur the Company Group nor to the knowledge of the Company Group, any of its officers, employees, oror agents, to Semnur’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity Authority pursuant to any similar policy. Neither Semnur nor the Company Group nor, to the Company Group’s knowledge, any of its officers, employees, contractors, and agents has (a) failed to disclose a material fact required to be disclosed to the FDA or any other Authority, (b) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Authority, or (c) committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity Authority to invoke a similar policy. Neither Semnur nor any of its officers, employees, or to Semnur’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.