Section 3.8 hereof, Knowledge, including the phrase to the Companys knowledge shall mean the actual knowledge of any Key Employee, F. Nicholas Franano and Marco Wong.
Major Investor means each of (i) MPM; (ii) TVM LSV VI GmbH and TVM LSV VI LP collectively, except that for purposes of Section 5.1(m) each of TVM LSV VI GmbH and TVM LSV VI LP individually shall be considered a Major Investor; (iii) Skyline IV; (iv) Prism V LP and Prism V-A LP, collectively; (v) Intersouth; (vi) Devon Park; (vii) Bessemer; (viii) Abingworth; (ix) Pharmstandard; and (x) Deerfield.
Management Rights Letter means the agreement between the Company and each Major Investor, dated as of the Initial Tranche Closing, in the form of Exhibit E attached to this Agreement or such other form as the Company and a Major Investor shall agree upon.
Material Adverse Effect means a material adverse effect on the business, assets (including intangible assets), liabilities, financial condition, property, prospects or results of operations of the Company; provided, however, that none of the following shall be deemed in themselves, either alone or in combination, to constitute, and none of the following shall be taken into account in determining whether there has been or will be, a Material Adverse Effect: (a) any failure by the Company to meet internal projections, forecasts or predictions on or after the date of this Agreement (provided that the underlying causes of such failure shall not be excluded from the determination of whether a Material Adverse Effect has occurred); (b) any adverse change, effect, event, occurrence, state of facts or development attributable to conditions affecting the industries in which Company participates as a whole or the U.S. economy as a whole, unless such change, effect, event, occurrence, state of facts or development affects the Company in a disproportionate manner; (c) any adverse change, effect, event, occurrence, state of facts or development attributable or relating to (i) out-of-pocket fees and expenses (including legal, accounting, investment banking and other fees and expenses) incurred in connection with the transactions contemplated by any of the Transaction Agreements or (ii) the payment of any amounts due to, or the provision of any other benefits (including benefits relating to acceleration of stock options) to, any officers or employees under employment contracts, non-competition agreements, employee benefit plans, severance arrangements or other arrangements in existence as of the date of this Agreement; (d) any adverse change, effect, event, occurrence, state of facts or development resulting from or relating to compliance with the terms of, or the taking of any action required by, any of the Transaction Agreements; or (e) any adverse change or effect on the business, assets, liabilities, financial condition or results of operations of the Company resulting from the conduct of the Companys business in the ordinary course of business in accordance with budgets approved by the Board of Directors of the Company from time to time, including, without limitation, (1) any reduction of the Companys cash balance as a result of incurring expenses in the ordinary course of business and the reduction of the Companys cash balance, (2) any increase in the Companys liabilities in the ordinary course of business or (3) any deterioration of the financial condition of the Company as a result of the activities contemplated in the foregoing clauses (1) and (2).
Milestones means the following milestones achieved in a Phase 3 clinical trial with NCT No. 02110901, enrolling no less than 285 patients, and which has been designed based upon FDAs guidance in the end-of-Phase 2 meeting with the Company to satisfy FDAs requirements of an adequate, well-controlled trial in support of a BLA filing: (i) statistically