Common use of Compliance with Regulatory Laws Clause in Contracts

Compliance with Regulatory Laws. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company: (A) is and at all times has been in compliance with all statutes, rules or regulations of the FDA and other comparable Governmental Entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), to the extent such activities are undertaken by the Company, except for any noncompliance that would not have a Material Adverse Effect; (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any Governmental Authority is considering such action; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

Compliance with Regulatory Laws. Except as described in the Registration Statement, the General Disclosure Package Package, the Prospectus and the French Listing Prospectus, the Company: (A) is and at all times has been in compliance with all statutes, rules or regulations of the FDA and other comparable Governmental Entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), to the extent such activities are undertaken by the Company, except for any noncompliance that would not have a Material Adverse Effect; (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any Governmental Authority is considering such action; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

Compliance with Regulatory Laws. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA FDA, the United States Department of Agriculture, the United States Department of Health and Human Services, the European Commission, the EMA, the Competent Authorities of the Member States of the European Economic Area or other comparable Governmental Entities federal, state, local or foreign governmental and regulatory authorities (collectively, the “Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product or product candidate under development, manufactured or distributed by the Company (“Applicable Laws”), to the extent such activities are undertaken by the Company, except for any noncompliance that would not have a Material Adverse Effect; (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental other Regulatory Authority alleging or asserting material noncompliance with any Applicable Laws or any permits, licenses, certificatesfranchises, exemptions, approvals, certifications, clearances, exemptionsconsents and other authorizations issued by Regulatory Authorities necessary to conduct the business now operated by the Company (collectively, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“AuthorizationsGovernmental Licenses”); (C) possesses all material Authorizations Governmental Licenses and such Authorizations Governmental Licenses are valid and in full force and effect, except where the invalidity of such Governmental Licenses or the failure of such Governmental Licenses to be in full force and effect would not, singly or in the aggregate, result in a Material Adverse Effect, and the Company is not in material violation of any term of any such AuthorizationsGovernmental Licenses; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Governmental Regulatory Authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations Governmental Licenses and has no knowledge that the FDA or any Governmental Regulatory Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any Governmental Regulatory Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations Governmental Licenses which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would result in a Material Adverse Effect, and has no knowledge that the FDA or any Governmental Regulatory Authority is considering such action; and (F) 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 Governmental Licenses and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

Compliance with Regulatory Laws. Except as described where the failure to comply would not, individually or in the Registration Statementaggregate, reasonably be expected to have a Material Adverse Effect, each of the Corporation, the General Disclosure Package Subsidiaries and their respective directors, officers and employees acting on behalf of the Prospectus, the CompanyCorporation or any Subsidiary: (A) is and at all times has been in compliance with all applicable federal, provincial, state, municipal, local, or foreign statutes, rules or regulations of rules, regulations, ordinances, orders, decrees and guidances including, without limitation, the FDA Food and other comparable Governmental Entities applicable to Drugs Act R.S.C. 1985, c. F-27, the ownershipCannabis Act, testingand the Controlled Drugs and Substances Act S.C. 1996, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”), to the extent such activities are undertaken by the Company, except for any noncompliance that would not have a Material Adverse Effectc. 19; (B) has not received any FDA Form 483correspondence, inspection report, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Authority alleging or asserting material noncompliance non-compliance with any Applicable Laws applicable laws or any licenseslicences, certificates, approvals, consents, clearances, exemptionsregistrations, qualifications, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws applicable laws (collectively, “Authorizations”); (C) possesses all material Authorizations required for the conduct of its business, and such Authorizations are valid and in full force and effect effect, and the Company is Corporation, the Subsidiaries and all directors, officers and employees of each acting on behalf of the Corporation or any Subsidiary are not in material violation of any term of any such AuthorizationsAuthorization; (D) has not received notice of any pending or threatened claim, action, suit, proceeding, charge, hearing, enforcement, audit, investigation, inspection, arbitration or other action from the FDA or any Governmental Authority or third party alleging that any product operation or activity of the Corporation, the Subsidiaries or any of their directors, officers and/or employees acting on behalf of the Corporation or any Subsidiary is in material violation of any Applicable Laws applicable laws or Authorizations and, except as disclosed in the Registration Statement and the Prospectuses, has no knowledge or reason to believe that the FDA or any such Governmental Authority or third party is considering or would have reasonable grounds to consider any such claim, litigation, arbitration, action, suit, investigation proceeding, charge, hearing, enforcement, audit, investigation, arbitration or proceedingother action; (E) has not received notice that the FDA or any Governmental Authority has taken, is taking taking, or intends to take action to limit, suspend, modify or revoke any material Authorizations and, except as disclosed in the Registration Statement, the Prospectuses and the Disclosure Package, has no knowledge or reason to believe that the FDA or any such Governmental Authority is considering taking or would have reasonable grounds to take such action; and (F) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, renewals, records, claims, submissions and supplements or amendments as required by any Applicable Laws applicable laws or Authorizations and to keep its Authorizations that are described or referred to in the Registration Statement, the Prospectuses and the Disclosure Package in good standing and that all such reports, documents, forms, notices, applications, renewals, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (G) has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning or other notice or action relating to the alleged safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the Corporation, there is no basis for any such notice or action.