contemplated hereby or by the Registration Statement and the Prospectus (including the issuance and sale of the Placement Shares and the use of the proceeds from the sale of the Placement Shares
as described in the Prospectus under the caption Use of Proceeds) will not (A) result in a material breach or violation of any of the terms and provisions of, or constitute a default under, any law, order, rule or regulation to
which the Company or any subsidiary is subject (including, without limitation, those promulgated by the Food and Drug Administration of the U.S. Department of Health and Human Services (the FDA) or by any foreign, federal,
state or local regulatory authority performing functions similar to those performed by the FDA), or by which any property or asset of the Company or any subsidiary is bound or affected, (B) conflict with, result in any violation or breach of,
or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or give to others any right of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) (a
Default Acceleration Event) of, any agreement, lease, credit facility, debt, note, bond, mortgage, indenture or other instrument (Contract) or obligation or other understanding to which the Company
or any subsidiary is a party or by which any property or asset of the Company or any subsidiary is bound or affected, except to the extent that such conflict, default, or Default Acceleration Event is not reasonably likely to result in a Material
Adverse Change, or (C) result in a breach or violation of any of the terms and provisions of, or constitute a default under, the Companys articles of incorporation (as the same may be amended or restated from time to time) or bylaws (as
the same may be amended or restated from time to time). Except as set forth in the Registration Statement and the Prospectus, neither the Company nor any of its subsidiaries is in violation, breach or default under its articles of incorporation (as
the same may be amended or restated from time to time), bylaws (as the same may be amended or restated from time to time) or other equivalent organizational or governing documents. Neither the Company nor any its subsidiaries nor, to its knowledge,
any other party is in violation, breach or default of any Contract that has resulted in or could reasonably be expected to result in a Material Adverse Change. Each approval, consent, order, authorization, designation, declaration or filing by or
with any regulatory, administrative or other governmental body necessary in connection with the execution and delivery by the Company of this Agreement and the performance of the Company of the transactions herein contemplated has been obtained or
made and is in full force and effect, except (i) with respect to any Applicable Time at which the Sales Agent would not be able to rely on Rule 5110(b)(7)(C)(i) of the Financial Industry Regulatory Authority, Inc.
(FINRA), such additional steps as may be required by FINRA, (ii) filings with the Commission required under the Securities Act or the Exchange Act, or filings or notice with the Exchange pursuant to the rules and
regulations of the Exchange, in each case that are contemplated by this Agreement to be made after the date of this Agreement, and (iii) such additional steps as may be necessary to qualify the Common Shares for sale by the Sales Agent under
state securities or Blue Sky laws.
(q) No Material Actions or Proceedings. There is no action, suit, proceeding, inquiry,
arbitration, investigation, litigation or governmental proceeding pending or, to the Companys knowledge, threatened against, or involving the Company or, to the Companys knowledge, any executive officer or director of the Company
including any proceeding before the FDA or any federal, state, local or foreign governmental bodies (it being understood that the interaction between the Company and the FDA and such comparable governmental bodies relating to the clinical
development and product approval process shall not be deemed proceedings for purposes of this representation), which is required to be disclosed and has not been disclosed in the Registration Statement or the Prospectus, except as would not,
individually or in the aggregate, reasonably be expected to have a Material Adverse Change.
(r) Labor Disputes. Except as set
forth in the Registration Statement and the Prospectus, there is not pending or, to the knowledge of the Company, threatened, any action, suit or proceeding to which the Company or any of its subsidiaries is a party or of which any property or
assets of the Company or any of its subsidiaries is the subject before or by any court or governmental agency, authority or body, or any arbitrator or mediator, except as would not, individually or in the aggregate, reasonably be expected to have a
Material Adverse Change.
(s) Compliance with Certain Applicable Laws. The Company: (A) is and at all times has been in
compliance, in all respects, with any and all applicable United States and Canadian federal, state, provincial, local and foreign laws, rules, regulations, treaties, statutes and codes promulgated by any and all governmental 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 manufactured or distributed by the Company
(Applicable Laws), except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (B) has not received any warning letter, untitled letter or other
correspondence or notice from any governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any
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