SEC Filings

10-K
ARRAY BIOPHARMA INC filed this Form 10-K on 08/11/2017
Entire Document
 
[ * ] = 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.


(D)    if the Party that is not conducting a Declined Clinical Study (the “Non-Performing Party”) determines reasonably and in good faith that the Declined Clinical Study is reasonably likely to adversely affect the Development or Commercialization of the Products in the Field, then the Party performing such Declined Clinical Study (the “Performing Party”) shall not undertake such Declined Clinical Study unless and until the JDRC determines that such Declined Clinical Study should be permitted; and
(E)    The Performing Party shall provide formal written reports of the results of the Declined Clinical Study and the costs of such Declined Clinical to the Non-Performing Party when such written reports are available, and the JDRC during meetings of the JDRC, upon request of the other Party but not more than twice a year during the period in which any study within the Declined Clinical Study is being performed. For clarity, Section 18.11 shall apply with respect to Declined Clinical Studies undertaken by either Party in accordance with this Section 4.4(c).
(ii)    Costs of Declined Clinical Studies and Use of related Data. The Performing Party shall bear all costs associated with Declined Clinical Studies it undertakes. If Ono (or an Ono Affiliate or Sublicensee) submits to a Regulatory Authority in Ono Territory Data generated by Array (including its Affiliates) or a Third Party Partner pursuant to a Declined Clinical Study (either directly or by reference under Section 4.8 below) for purposes of obtaining new or expanded Marketing Approval for the Product for the same Indication that was the subject of study in such Declined Clinical Study, Ono shall reimburse Array an amount equal to [ * ] of the costs incurred by Array (including by its Affiliates) and/or such Third Party Partner for the Declined Clinical Study. If Array (including its Affiliates) and/or PFM submits to a Regulatory Authority in the Array Territory Data generated by Ono pursuant to a Declined Clinical Study (either directly or by reference under Section 4.8 below) for purposes of obtaining new or expanded Marketing Approval for the Product for the same Indication that was the subject of study in such Declined Clinical Study, Array shall reimburse Ono an amount equal to [ * ] of the costs incurred by Ono (including by its Affiliates) for the Declined Clinical Study. Notwithstanding the foregoing, in the event that Ono is the Non-Performing Party and the PMDA (or MHLW), based on the fact that the Declined Clinical Study utilized clinical sites in Japan, compels Ono to file for a new or expanded Marketing Approval for the Product based on the Data generated by Array pursuant to a Declined Clinical Study, then the foregoing obligation to reimburse Array [ * ] of the costs of the Declined Clinical Study shall be waived.
(d)    Except for Investigator Sponsored Clinical Studies included in the Existing Clinical Studies, neither Party shall authorize or support an Investigator Sponsored Clinical Study or any Post-Approval Marketing Clinical Study in the other Party’s territory without obtaining prior written consent.
(e)    Development Efforts; Manner of Performance; Reports.

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