|ARRAY BIOPHARMA INC filed this Form 10-K on 08/11/2017|
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
court of competent jurisdiction; (b) if a voluntary or involuntary petition in bankruptcy is filed in any court of competent jurisdiction against such other Party and such petition is not dismissed within ninety (90) days after filing; (c) if such other Party shall make or execute an assignment of substantially all of its assets for the benefit of creditors; or (d) substantially all of the assets of such other Party are seized or attached and not released within ninety (90) days thereafter.
13.5 Termination for Safety Reasons and Efficacy Reason.
(a) Ono shall have the right to terminate this Agreement, on a Product-by-Product basis, for Safety Reasons upon thirty (30) days written notice to Array or within a shorter period if required under applicable Law, but only after consulting with Array and obtaining Array’s agreement with Ono’s assessment with respect to such Safety Reasons (or as provided for below, the agreement of the Experts). Ono shall have the right to terminate this Agreement for Efficacy Reasons upon one hundred and eighty (180) days written notice to Array.
(b) If Array disagrees with Ono’s assessment with respect to Safety Reasons, such matter shall be resolved in accordance with the procedures set forth in Section 17.2, which shall apply mutatis mutandis, which Experts shall determine whether the Safety Reasons are justified and are unlikely to be reversed, within a reasonable period of time with a commercially reasonable level of investment. The opinion of the majority of the Experts shall be finally binding on the Parties.
(c) “Safety Reasons” shall mean that, based upon all relevant scientific data, there are safety and public health issues relating to the Product such that the medical benefit/risk ratio of such Product is sufficiently unfavorable as to materially compromise the welfare of patients so that the use in patients is no longer justifiable and that such issues are unlikely to be reversed within a reasonable period of time with a commercially reasonable level of investment.
(d) “Efficacy Reasons” shall mean that either (i) there is no efficacy or lower efficacy of the Products in comparison with control arm in COLUMBUS Clinical Study as well as BEACON Clinical Study (neither triplet therapy nor doublet therapy demonstrates statistically significant efficacy in comparison with control arm), or (ii) as of the fifth anniversary of the Effective Date, neither BRAF-mutant Melanoma and Marketing Approval nor BRAF-mutant colorectal cancer have received Marketing Approval from MHLW.
EFFECT OF TERMINATION