|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.
(iv) review, discuss and accept or reject Joint Clinical Study Proposals submitted by either Party;
(v) prepare any Joint Development Plans with respect to any Joint Clinical Study Proposals agreed by the Parties as well as any changes to such Joint Development Plans;
(vi) review, discuss and accept or reject any changes to the Joint Development Plans;
(vii) oversee both Parties’ implementation of the Joint Development Plans, allocate responsibilities to each Party in connection with executing such Joint Development Plans and review Ono’s execution of its responsibilities under the Development Plan
(viii) review, discuss and accept or reject clinical study design and protocols for Clinical Studies included in the Development Plan or within any Joint Development Plan, including clinical study endpoints, clinical methodology and monitoring requirements for such Clinical Studies;
(ix) establish, review and update the IST Guidelines; review and discuss plans for any proposed Investigator Sponsored Clinical Studies that are not expressly authorized in the IST Guidelines;
(x) discuss clinical supply and CMC activity;
(xi) review and discuss the regulatory strategy and Market Access strategies for the Product in the Ono Territory (and substantive amendments and updates thereto);
(xii) provide a forum for the Parties: (A) to discuss and agree upon, material issues pertaining to the Development of the Product for the Ono Territory, and matters pertaining to Regulatory Filings for the Product in the Ono Territory; and (B) to coordinate their respective activities with respect to the foregoing matters;
(xiii) provide a forum for resolving disputing and other matters referred to the JDRC under this Agreement, pursuant to the procedures set out in Section 3.5 below; and
(xiv) perform such other duties as are specifically assigned to the JDRC in this Agreement.