|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.
(c) Ownership of Marketing Approvals. Ono or an Ono Affiliate shall own and maintain Marketing Approvals for the Products in the Field in the Ono Territory including all regulatory submissions and applications, provided that Ono may assign Marketing Approvals for the Product to its Affiliates or permitted Sublicensees to the extent that such Affiliates or permitted Sublicensees have been delegated primary responsibility for the commercialization of the Product in such countries. As between the Parties, Array or an Array Affiliate shall own all regulatory submissions, including all applications, for Marketing Approvals for the Products in the Field in the Array Territory.
(d) Regulatory Cooperation. Except with respect to (i) the Existing Clinical Studies, (ii) any Approved Clinical Studies for which Array is the owner of the IND in a given country in the Ono Territory, and/or (iii) with respect to Clinical Studies conducted by Array in one or more countries of the Ono Territory pursuant to Section 4.5 above, Ono shall be responsible for liaising with and managing all interactions with Regulatory Authorities in the Ono Territory, including with respect to all Regulatory Filings for the Product in the Ono Territory (other than the Array Regulatory Filings) and Array shall cooperate with Ono in such regulatory interactions (e.g. Ono’s correspondence to matters of inquiry from Regulatory Authorities) in a timely manner. Array shall be entitled to participate in such interactions as provided in this Section 4.6(d) subject to receipt of any required permissions of such Regulatory Authorities in the Ono Territory. Ono shall be entitled to participate in interactions with Regulatory Authorities in Korea with respect to the Existing Clinical Studies as provided in this Section 4.6(d) subject to receipt of any required permissions of such Regulatory Authorities in Korea. Ono shall also be entitled to attend selected material meetings with the FDA as an observer.
(i) To the extent relating to a Product within the Ono Territory or activities under this Agreement, Ono shall provide Array with:
(A) reasonable advanced notice of substantive meetings (or telephone or similar substantive interactions) that are either scheduled or initiated by or under the authority of Ono with a Regulatory Authority in the Ono Territory and immediate notice of any unscheduled substantive interactions that are initiated by such a Regulatory Authority (including, the PMDA or MHLW or any committee to whom the PMDA or MHLW have delegated activities relating to the review or approval of MAAs filed with the PMDA) other than meetings or interactions with any such Regulatory Authority pertaining to Pricing and Reimbursement Approval of the Product in the applicable country, and advance copies of all related documents and other relevant information relating to such meetings or other contact except where the provision of advance copies is not possible as in the case of unscheduled substantive interactions that are initiated by a Regulatory Authority.
(B) an opportunity to have up to two (2) representatives attend all substantive meetings and interactions with Regulatory Authorities in the Ono Territory, subject to receipt of any required permissions of such Regulatory Authorities in the Ono Territory, and if requested by Ono or required