Company Material Adverse Effect means any (x) termination of the Commercial Supply Agreement, dated as of October 9, 2013, by and between the Company and LTS Xxxxxxx Therapy Systems Corp. or the Interim Supply Agreement, dated as of October 9, 2013, by and between the Company, LTS Xxxxxxx Therapy Systems Corp. and LTS Xxxxxxx Therapy Systems Corp. or (y) change, effect, event, occurrence, state of facts or development which individually or in the aggregate (i) results in any change or effect that is materially adverse to the business, financial condition, properties, assets, liabilities (contingent or otherwise) or results of operations of the Company, taken as a whole, (ii) prevents or materially impedes, interferes with, hinders or delays the consummation by the Company of the Merger or the other transactions contemplated by this Agreement, or (iii) results in the inability of the Company to manufacture at least 500,000 units of the Core Product per year; provided that none of the following shall be deemed, either alone or in combination, to constitute a Company Material Adverse Effect: (A) any change relating to the economy or securities markets in general, (B) any adverse change, effect, event, occurrence, state of facts or development attributable to conditions affecting the industry in which the Company participates, including any changes to reimbursement rates related to any Products, (C) any failure, in and of itself, by the Company to meet any internal or published projections, forecasts or revenue or earnings predictions for any period ending on or after the date of this Agreement (provided, that the underlying causes of such failure may be considered in determining whether a Company Material Adverse Effect has occurred), (D) the effect of any change in any applicable Law or GAAP or (E) any change, effect, event, occurrence, state of facts or development resulting from the execution, pendency or pursuit of the transactions contemplated hereby, including any Litigation resulting therefrom, or any action required pursuant to the terms of this Agreement; except, in the cases of clauses (A), (B) or (D) above, if such change, effect, event, occurrence, state of facts or development disproportionately affects the Company, in a material respect, as compared to other participants in the industry in which the Company participates.