(m) Non-Contravention of Existing Instruments. The Company is not in violation of its certificate of incorporation or by-laws, and is not in default (nor would it be, with the giving of notice or lapse of time, in default) under any indenture, mortgage, loan or credit agreement, note, guarantee, contract, franchise, lease or other instrument to which the Company is a party or by which it is bound (including, without limitation, any credit agreement, guarantee, indenture, pledge agreement, security agreement or other instrument or agreement evidencing, guaranteeing, securing or relating to indebtedness of the Company, if any), or to which any of the property or assets of the Company is subject (each, an Existing Instrument), except for such defaults as would not be reasonably expected to, individually or in the aggregate, result in any change or effect in the business, operations, results of operations, assets, capitalization, financial condition, rights or liabilities of the Company which is materially adverse to the business, operations or financial condition of the Company (a Material Adverse Effect). The Companys execution, delivery and performance of this Agreement, the consummation of the transactions contemplated hereby and by the Prospectus and the issuance and sale of the Public Shares (i) will not result in any violation of the provisions of the constitutive documents or the by-laws of the Company, (ii) will not conflict with or constitute a breach of, or default or a Debt Repayment Triggering Event (as defined below) under, or result in the creation or imposition of any lien, charge or encumbrance upon any property or assets of the Company pursuant to, or require the consent of any other party to, any Existing Instrument except for such conflicts, breaches, defaults or a Debt Repayment Triggering Event as would not be reasonably expected to, individually or in the aggregate, result in a Material Adverse Effect and (iii) will not result in any material violation of any law, administrative regulation or administrative or court decree applicable to the Company. As used herein, a Debt Repayment Triggering Event means any event or condition which gives, or with the giving of notice or lapse of time would give, the holder of any note, debenture or other evidence of indebtedness (or any person acting on such holders behalf) the right to require the repurchase, redemption or repayment of all or a portion of such indebtedness by the Company.
(n) Change in Legislation. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any legislation, or proposed legislation, which it reasonably expects will materially and adversely affect the business, affairs, operations, assets, liabilities (contingent or otherwise) or prospects of the Company.
(i) FDA, and Other Regulatory Authorities. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company holds all licenses, certificates, approvals and permits from all provincial, federal, state, United States, foreign and other regulatory authorities, including but not limited to the United States Food and Drug Administration (the FDA), the European Medicines Agency (the EMA) and any foreign regulatory authorities performing functions similar to those performed by the FDA and the EMA, that are material to the conduct of the business of the Company as such business is now conducted as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, all of which are valid and in full force and effect and there is no proceeding pending or, to the knowledge of the Company, threatened which may cause any such license, certificate, approval or permit to be withdrawn, cancelled, suspended or not renewed.
(ii) No filing or submission to the FDA, the EMA or any other regulatory body, that was or is intended to be the basis for any approval of the Companys products or product candidates, to the knowledge of the Company, contains any material omission or material false information.
(iii) The Company is not in violation in any material respect, of any material law, order, rule, regulation, writ, injunction or decree of any court or governmental agency or body, applicable to the investigation of new drugs in humans and animals, including, but not limited to, those promulgated by the FDA or the EMA.
(o) Medical Devices. The Company is in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (FDC Act) and the Radiation Control for Safety and Health Act of 1968 (the Safety Act) relating to medical devices. Each device that the Company manufactures, causes to be manufactured and distributes or causes to be distributed for sale (the Company Devices) is the subject of a 510(k) premarket notification which resulted in a finding of substantial equivalence by FDA or such device qualifies for exemption from 510(k) premarket notification requirements or is subject to a Pre-Market Approval (PMA) by the FDA. None of the Company Devices found substantially equivalent by the FDA have been modified in such a manner as to require the submission of a new 510(k) premarket notification. The Company believes that none of the Company Devices have been labeled or promoted in such a manner as to require the submission of a new 510(k) notification or a new PMA. All the Company Devices being commercialized are listed with the FDA and have been manufactured in a facility registered by the Company with FDA. The Company has obtained the necessary regulatory approvals for its manufacturing facility, and the facility currently has no outstanding adverse inspections or audits. All Company Devices manufactured by the Company or which the Company causes to be manufactured