|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.
JCC, as applicable. It is also understood that no Committee shall have any authority to take any decision over activities related to the registration and/or commercialization of the Product for use in the Array Territory.
3.9 Cost of Governance. The Parties agree that the costs incurred by each Party in connection with its participation at any meetings under this Article 3 shall be borne solely by such Party.
DEVELOPMENT AND REGULATORY ACTIVITIES
(a) General. Except as otherwise expressly provided in a Joint Development Plan, Ono (itself or through its Affiliates or respective licensees or sublicensees) shall be responsible for the Development of the Products for the Ono Territory. All Development activities conducted by or on behalf of Ono hereunder shall be conducted in accordance with the Development Plan or Joint Development Plan(s), as applicable, and in compliance with applicable Law, including laws regarding environmental, safety and industrial hygiene, Good Laboratory Practice and Good Clinical Practice, current standards for pharmacovigilance practice, and all applicable requirements relating to the protection of human subjects. Except as otherwise set forth in a Joint Development Plan, Ono shall bear all of the costs and expenses which it incurs in connection with any of the activities it performs in the course of the Development of the Products for the Ono Territory.
(b) Collaborative Development. The Parties recognize that since the Products will be developed both in the Ono Territory and the Array Territory, regulatory and budget efficiencies can be achieved through the Parties’ coordination and worldwide use of preclinical and clinical data and in cooperatively conducting certain joint Clinical Studies. Accordingly, the Parties agree that it is their mutual interest to cooperatively conduct the Approved Clinical Studies to be agreed upon and set forth in Joint Development Plans as described in Section 4.4 below.
(c) Current Development Status. Prior to the Effective Date, Novartis AG (“Novartis”) and/or Array have independently initiated the following Clinical Studies of the Products: (i) a Phase III clinical trial in NRAS Melanoma (“NEMO Clinical Study”), (ii) a Phase III clinical trial in BRAF Melanoma (“COLUMBUS Clinical Study”), (iii) a Phase III clinical trial in BRAF Colorectal Cancer (“BEACON Clinical Study”), and (iv) those additional Phase 1 and Phase 2 Clinical Studies and Investigator Sponsored Clinical Studies set forth in Exhibit 4.1 (collectively, the “Existing Clinical Studies”). Array shall use Diligent Efforts to complete, at its expense, the Existing Clinical Studies (including all pharmacovigilance aspects), including contracting and managing any contract research organization(s) that may be involved in such Existing Clinical Studies, and Array shall keep the JDRC informed of the status thereof and Ono