|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.
Ono Territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Product in the Ono Territory). Each Party shall promptly notify the other Party with respect to any material changes or material issues that may arise in connection with any IND for the Product filed by or under the authority of such Party as the sponsor, and/or any Marketing Approvals for the Product, in any country within such Party’s territory.
(b) The Parties shall enter into pharmacovigilance agreements on reasonable and customary terms no less stringent than those required by applicable ICH Guidelines, including: (i) providing detailed procedures regarding the responsibilities for the creation and maintenance of core safety information (e.g.,: Core Data Sheet, Risk Management Plan, Local Product Safety Labeling, Development and Product Safety Updates); (ii) the exchange of safety data relating to the Product within and outside the Ono Territory within appropriate time frames and in an appropriate format to enable each Party to meet its expedited and periodic regulatory reporting requirements; and (iii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of safety data in accordance with all applicable legal and regulatory requirements regarding the management of safety data. Promptly following the Effective Date but no later than sixty (60) days before Ono’s IND filing for the first Clinical Study in the Ono Territory, the Parties shall enter into such a pharmacovigilance agreement, which shall be applicable to such pre-marketing safety information that will be available from Clinical Studies. As soon as practicable following the Effective Date, the Parties shall initiate negotiation of a post-marketing safety data exchange agreement, and shall enter into such agreement no later than sixty (60) days before approval of such MAA by Regulatory Authority (or as otherwise agreed by the Parties), which shall be applicable to such post-marketing safety information that will be available from post-marketing experiences with the Product.
COMMERCIALIZATION AND PROMOTION
5.1 Ono Commercialization.
(a) Ono’s Responsibility. Except as provided below, Ono shall be responsible for, and shall control the conduct of, the Commercialization of the Products in the Ono Territory, at its expense, in accordance with Section 8.1.
(b) Commercialization Plan.
(i) No later than one hundred eighty (180) days prior to the anticipated filing of the first MAA in the Ono Territory, Ono shall provide Array with the plan for Commercialization of the Product in the Ono Territory (“Commercialization Plan”) through JCC. Further, Array shall also provide Ono with Array’s plan for commercialization of the Product in USA and, to the extent it is able to do so