|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.
shall have the opportunity to comment on the progress of the BEACON study through the JDRC. As between the Parties: (and subject to applicable agreements and consent requirements) Array shall have the right to implement modifications to any Existing Clinical Study(ies), provided that Array shall not implement any modification to any Existing Clinical Study(ies) that would prejudice Ono as regards safety or reputational issues, or the intended objectives for such Clinical Studies, or cause a material delay in such Existing Clinical Study(ies), and provided further that Array shall use Diligent Efforts to keep Ono informed through the JDRC of any material modification to any Existing Clinical Study(ies) being conducted in the Ono Territory.
(d) Investigator Sponsored Clinical Studies. Notwithstanding Section 3.1(b)(viii) above, Ono shall have the right to authorize the protocol for Investigator Sponsored Clinical Study in the Ono Territory and support such Clinical Study at Ono’s own discretion so long as such study does not fall within one of the categories listed in the IST Guidelines, however Ono agrees to inform Array of all such Investigator Sponsored Clinical Study(ies) in order to allow Array to provide Ono comments with respect to such proposed Investigator Sponsored Clinical Study(ies) in a timely manner. For clarity, in the event that a proposed Investigator Sponsored Clinical Study falls within one of the categories listed in the IST Guidelines, then authorization of such Investigator Sponsored Clinical Study shall require the agreement between the Parties through the JDRC.
4.2 Development Plan; Amendments.
(a) Initial Development Plan. Promptly following the Effective Date, and in any event within one hundred and twenty (120) days following the Effective Date, Ono shall prepare a plan detailing the Development activities (“Development Plan”), if any, that are necessary for obtaining Marketing Approval in the Ono Territory of (i) a Binimetinib Product and an Encorafenib Product for BRAF-mutant melanoma and (ii) a Binimetinib Product and an Encorafenib Product for BRAF-mutant colorectal cancer for review, discussion and approval (or rejection) by the JDRC. The initial Development Plan shall outline all of the regulatory activities, as well as of the Development activities, if any, planned to be conducted in order to obtain Marketing Approval in each country in the Ono Territory for the Products and Indications described in (i) and (ii) above and shall set out a more detailed description of the designs for any (A) all Clinical Studies, (B) pre-clinical studies and (C) other Development activities, that may be are necessary for obtaining the above referenced Marketing Approval and which are planned to be conducted during the first twelve (12) month period covered by such plan.
(b) Updates and Changes to the Development Plan. Ono shall provide to the JDRC, for its review, discussion and approval (or rejection), an updated version of the Development Plan at least once each Fiscal Year, at the first JDRC meeting in each Fiscal Year; and such updated Development Plan shall include at least the level of detail regarding Ono’s Development and