Common use of Regulatory Clause in Contracts

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicable, the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement Statement, the Time of Sale Disclosure Package and the Final Prospectus, as applicable, the Company and its Subsidiaries : (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Laws Regulations (as defined below) or any Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or Authorizations and that all such reportsother authority, documentsbody or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, forms, notices, applications, records, claims, submissions and supplements assets or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityoperations.

Regulatory. Except as described in the Registration Statement Statement, the Time of Sale Disclosure Package and the Final Prospectus, as applicable, : (A) the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Laws Regulations (as defined below) or any Authorizations (as defined below); (B) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (C) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or Authorizations and that all such reportsother authority, documentsbody or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, forms, notices, applications, records, claims, submissions and supplements assets or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityoperations.

Regulatory. Except as described in the Registration Statement Statement, the Time of Sale Disclosure Package and the Final Prospectus, as applicable, the Company and its Subsidiaries : (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, neither the “Applicable Laws”); (ii) have not Company nor any subsidiary has received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Laws Regulations (as defined below) or any Authorizations (as defined below); (ii) the Company and each subsidiary is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company and each subsidiary possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company and each subsidiary is not in violation of any term of any such Authorizations; (iv) have not neither the Company nor any subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company or any subsidiary that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have not neither the Company nor any subsidiary has received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor any subsidiary, suspensionnor to the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or Authorizations and that all such reportsother authority, documentsbody or agency (whether foreign or domestic) having jurisdiction over the Company or its subsidiaries or any of its properties, forms, notices, applications, records, claims, submissions and supplements assets or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityoperations.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) the Company possesses all material licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and to the Company’s knowledge, such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described disclosed in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) the Company possesses all material licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and to the Company’s knowledge, such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described in the Registration Statement Statement, the Time of Sale Disclosure Package and the Final Prospectus, as applicable, the Company and its Subsidiaries : (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, neither the “Applicable Laws”); (ii) have not Company nor any subsidiary has received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Laws Regulations (as defined below) or any Authorizations (as defined below); (ii) the Company and each subsidiary is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company and each subsidiary possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company and each subsidiary is not in violation of any term of any such Authorizations; (iv) have not neither the Company nor any subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company or any subsidiary that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have not neither the Company nor any subsidiary has received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor any subsidiary, suspensionnor to the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or Authorizations and that all such reportsother authority, documentsbody or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, forms, notices, applications, records, claims, submissions and supplements assets or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityoperations.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Prospectus and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is conducting and has conducted its business and operations in compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action or any other action that would result in a Material Adverse Change. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws. All initial patient studies and testing conducted by or on behalf of the Company were and, if still ongoing, are being conducted in material compliance with all Applicable Laws in the jurisdictions in which they are being conducted. Except as disclosed in the Registration Statement, the Pricing Prospectus and the Prospectus, the Company has not received any written notices or Authorizations statements from the U.S. Food and Drug Administration, the European Medicines Agency or any other governmental agency or authority requiring, requesting or suggesting that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are Lumega-Z is not a party to regulated medical food or that MapcatSF is not a Class I medical device. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, product as it is currently marketed and sold. The Company has no knowledge of any regulatory actions that will adversely impact the manufacturer of its products or similar agreements with or imposed by any governmental or regulatory authorityits products.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws Regulations (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company's knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityRegulations.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws Regulations (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityRegulations.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicable, the The Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement Offering Statement, the Pricing Disclosure Materials and the ProspectusFinal Offering Circular or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are the Company is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to its business the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iviii) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by a Governmental Entity; and (viv) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitation, suspension, modification Governmental Entity has threatened or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all is considering such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityaction.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Prospectus and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company's knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicableSEC Reports, the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business the Company including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement Statement, the Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are the Company is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to its business the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iviii) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (viv) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agent has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described in the Registration Statement Statement, the Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are the Company is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to its business the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iviii) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (viv) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described in the Registration Statement SEC Reports and the Prospectus, as applicableon Schedule 3.1(f), the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business the Company including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are the Company is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to its business the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iviii) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by a Governmental Entity; and (viv) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitation, suspension, modification Governmental Entity has threatened or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all is considering such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityaction.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have has not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess possesses all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials in all material respects; and (vii) the descriptions in the SEC Documents of the results of such clinical trials are not a party consistent in all material respects with such results and to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, the Company’s knowledge there are no other studies or similar agreements other clinical trials whose results are materially inconsistent with or imposed otherwise materially call into question the results described or referred to in the SEC Documents. The Company uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials that are described in the SEC Documents and, based upon (i) the information provided to the Company by any governmental or regulatory authoritythe third parties conducting such studies, tests, preclinical studies and clinical trials and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement Statement, the Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are the Company is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to its business the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iviii) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (viv) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company's knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described in the Registration Statement SEC Reports and the Prospectus, as applicableon Schedule 3.1(f), the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business the Company including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. Sec. 1320a-7b(b)), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Prospectus and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described would not reasonably be expected to result, individually or in the Registration Statement and the Prospectusaggregate, as applicable, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court governmental agency or arbitrator court, domestic or governmental foreign, having jurisdiction over the Company or regulatory authority any of its assets or third party business (each, a “Governmental Entity”) alleging or asserting noncompliance with any Applicable Laws Regulations (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, permitsqualifications, registrations registrations, permits and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitation, suspension, modification Governmental Entity has threatened or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all is considering such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityaction.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Prospectus and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) to the Company’s knowledge, the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) to the Company’s knowledge, the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described in the Registration Statement Statement, the Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are the Company is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to its business the Company (collectively, the “Applicable Laws”); (iiiii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitation, suspension, modification Governmental Entity has threatened or revocation threatenedis considering such action; and (vi) have the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete complete, correct and accurate not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party . Neither the Company nor, to the Company’s knowledge, any corporate integrity agreementsof its directors, monitoring agreementsofficers, consent decrees, settlement orders, employees or similar agreements with or imposed by agents has been convicted of any governmental or regulatory authoritycrime under any Applicable Laws.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicableSEC Reports , the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business the Company including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Prospectus and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) to the Company’s knowledge, the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) to the Company’s knowledge, the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company's knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and rules, or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; and (vii) the descriptions in the SEC Documents of the results of such clinical trials are not a party consistent in all material respects with such results and to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, the Company’s knowledge there are no other studies or similar agreements other clinical trials whose results are materially inconsistent with or imposed otherwise materially call into question the results described or referred to in the SEC Documents. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials and, based upon (i) the information provided to the Company by any governmental or regulatory authoritythe third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, in a Material Adverse Change, the Company and its Subsidiaries Company: (iA) are is and at all times have has been in material compliance with all statutes, rules and rules, or regulations applicable to its business the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (iiB) have has not received any notice of adverse finding, warning letter, or other similar correspondence or notice from any court or arbitrator or governmental or regulatory authority or third party other Governmental Entity alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in material violation of any term of any such Authorizations, in each case except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor and has no knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatenedAuthorizations; (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct on the date filed (or were corrected or supplemented by a subsequent submission); and (viiG) are not a party to any corporate integrity agreementshas not, monitoring agreementseither voluntarily or involuntarily, consent decreesinitiated, settlement ordersconducted, or similar agreements with issued or imposed by caused to be initiated, conducted or issued, any governmental recall, market withdrawal or regulatory authorityreplacement, safety alert, or other notice or action relating to the alleged lack of safety of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate any such notice or action.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicable, or as would not constitute a Material Adverse Effect, the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were conducted, and, if still pending, are, in all material respects, being conducted, in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act or any; the descriptions of the top-line results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the top-line data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the top-line results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authority.preclinical studies and clinical trials are accurate and complete in all material respects

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableOTC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are was and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and rules, or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any court federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement Statement, the Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws Regulations (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company's knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityRegulations.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). To the Company's knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except Since August 31, 2019, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and its Subsidiaries Subsidiary: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiary (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any court federal, state, or arbitrator or foreign governmental or regulatory quasi-governmental authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Since August 31, 2019, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiary. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and its Subsidiaries Company: (iA) are was and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and rules, or regulations applicable to its business Company (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have has not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess possesses all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials in all material respects; and (vii) the descriptions in the SEC Documents of the results of such clinical trials are not a party consistent in all material respects with such results and to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, the Company’s knowledge there are no other studies or similar agreements other clinical trials whose results are materially inconsistent with or imposed otherwise materially call into question the results described or referred to in the SEC Documents. The Company uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials that are described in the SEC Documents and, based upon (i) the information provided to the Company by any governmental or regulatory authoritythe third parties conducting such studies, tests, preclinical studies and clinical trials and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and rules, or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other applicable regulation of a xxxxxxx, xxxxxxxxxx, xxxxx, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation and to the extent applicable, the United States Public Health Service Act, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement and Statement, the Disclosure Package, the Prospectus, and the SEC Reports or as applicablewould not reasonably be expected to result, individually or in the Company and its Subsidiaries aggregate, in a Material Adverse Change: (i) are the Company is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to its business the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iviii) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by a Governmental Entity; and (viv) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitation, suspension, modification Governmental Entity has threatened or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all is considering such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityaction.

Regulatory. Except Since August 31, 2019, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and its Subsidiaries Subsidiary: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiary (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Since August 31, 2019, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiary. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); . During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws. The Company has not received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (viiii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityaccurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are was and at all times have has been in material compliance with all applicable U.S., Irish and other foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials in all material respects; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and except as described in the SEC documents, the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company's knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except as described in the Registration Statement and SEC Reports or as would not reasonably be expected to result, individually or in the Prospectusaggregate, as applicablein a Material Adverse Change, the Company and its Subsidiaries Company: (iA) are is and at all times have has been in material compliance with all statutes, rules and rules, or regulations applicable to its business the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (iiB) have has not received any notice of adverse finding, warning letter, or other similar correspondence or notice from any court or arbitrator or governmental or regulatory authority or third party other Governmental Entity alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess possesses all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in material violation of any term of any such Authorizations, in each case except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor and has no knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatenedAuthorizations; (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct on the date filed (or were corrected or supplemented by a subsequent submission); and (viiG) are not a party to any corporate integrity agreementshas not, monitoring agreementseither voluntarily or involuntarily, consent decreesinitiated, settlement ordersconducted, or similar agreements with issued or imposed by caused to be initiated, conducted or issued, any governmental recall, market withdrawal or regulatory authorityreplacement, safety alert, or other notice or action relating to the alleged lack of safety of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate any such notice or action.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have has not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess possesses all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies and tests contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies and tests in all material respects; and (vii) to the Company’s knowledge there are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements no other studies whose results are materially inconsistent with or imposed otherwise materially call into question the results described or referred to in the SEC Documents. The Company uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical studies that are described in the SEC Documents and, based upon (i) the information provided to the Company by any governmental or regulatory authoritythe third parties conducting such studies, tests, and preclinical studies and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, and preclinical studies are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement Statement, the Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are the Company is and at all times have has been in material compliance with all statutes, laws, ordinances, rules and regulations applicable to its business the Company (collectively, the “Applicable Laws”); (iiiii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitation, suspension, modification Governmental Entity has threatened or revocation threatenedis considering such action; and (vi) have the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete complete, correct and accurate not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party . Neither the Company nor, to the Company's knowledge, any corporate integrity agreementsof its directors, monitoring agreementsofficers, consent decrees, settlement orders, employees or similar agreements with or imposed by agents has been convicted of any governmental or regulatory authoritycrime under any Applicable Laws.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). To the Company's knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are was and at all times have has been in material compliance with all applicable U.S., England, Wales and other foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials in all material respects; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and except as described in the SEC documents, the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement Offering Statement, the Pricing Disclosure Package and the ProspectusFinal Offering Circular or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws Regulations (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, permitsqualifications, registrations registrations, permits and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitation, suspension, modification Governmental Entity has threatened or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all is considering such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityaction.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement Offering Statement, the Pricing Disclosure Package and the ProspectusFinal Offering Circular or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws Regulations (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company's knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityRegulations.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and its Subsidiaries Company: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to its business Company (collectively, the “Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any court federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). To the Company's knowledge, all studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been to the Company’s knowledge in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and each of its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiAuthorizations”);(C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions in the SEC Document of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and rules, or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filednot failed to file, obtainedobtain, maintained maintain or submitted all submit any material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations that would, individually or in the aggregate constitute a Material Adverse Effect, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement Offering Statement, the Pricing Disclosure Package and the ProspectusFinal Offering Circular or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws Regulations (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws Regulations and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company’s knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityRegulations.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any court federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except as described in the Registration Statement and SEC Documents, during the Prospectus, as applicable12-month period immediately preceding the date hereof, the Company and each of its Subsidiaries Subsidiaries: (iA) are was and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and rules, or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; and (vii) the descriptions in the SEC Documents of the results of such clinical trials are not a party consistent in all material respects with such results and to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, the Company’s knowledge there are no other studies or similar agreements other clinical trials whose results are materially inconsistent with or imposed otherwise materially call into question the results described or referred to in the SEC Documents. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials and, based upon (i) the information provided to the Company by any governmental or regulatory authoritythe third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been to the Company’s knowledge in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and each of its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions in the SEC Document of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are was and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and rules, or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any court federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s actual knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and regulations rules, regulations, or guidance applicable to Company and its business Subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any material claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). To the Company's knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the Prospectuses are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the Prospectuses; and (vii) are the Company has not a party to received any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, notices or similar agreements with or imposed by correspondence from any governmental authority requiring the termination, suspension or regulatory authoritymaterial modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the Prospectuses and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, as applicableindividually or in the aggregate, the Company and its Subsidiaries in a Material Adverse Change: (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the “Applicable Laws”); (ii) have Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging or asserting noncompliance with any Applicable Laws (as defined in clause (ii) below) or any Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Laws”); (iii) the Company possesses all licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws and/or to carry on its businesses as now conducted (“Authorizations”); (iii) possess all material Authorizations and to the Company’s knowledge, such Authorizations are valid and in full force and effect and are the Company is not in violation of any term of any such Authorizations; (iv) have the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) have the Company has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Entity has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitationGovernmental Entity has threatened or is considering such action. Neither the Company nor, suspensionto the Company's knowledge, modification any of its directors, officers, employees or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by agents has been convicted of any crime under any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration Statement and the Prospectus, as applicableSEC Documents, the Company and each of its Subsidiaries Subsidiaries: (iA) are is and at all times have has been in material compliance with all applicable U.S. and foreign statutes, rules and rules, or regulations applicable to Company and its business Subsidiaries (collectively, the “Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiB) have not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any court other federal, state, or arbitrator or foreign governmental or regulatory authority or third party having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iiiC) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority Governmental Authority or third party alleging that any product product, operation or activity is in violation of any Applicable Laws or Authorizations nor and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (vE) have not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is and the Company has no knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; and (viF) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). During the 12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other applicable regulation of a federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials and, based upon (viii) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are not a party to any corporate integrity agreementsdescribed in the SEC Documents and the Company’s review of such information, monitoring agreementsand (ii) the Company’s knowledge, consent decreesthe Company reasonably believes that the descriptions of the results of such studies, settlement orderstests, or similar agreements with or imposed by any governmental or regulatory authoritypreclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement and the Prospectus, as applicableSEC Reports, the Company and its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business the Company and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable Laws”)) except for such noncompliance which in the aggregate would not reasonably be expected to have a Material Adverse Effect; (ii) have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (iv) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action overtly threatened; (v) have not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation overtly threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed field (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.