|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.
Encorafenib combination the highest priority in case Array intends to sponsor any Clinical Study of Binimetinib and/or Encorafenib in combination with a [ * ] in the Ono Territory.
For clarity, it is understood and agreed that (w) nothing in this Section 4.5 shall prevent Array from supplying Third Parties with Binimetinib, Encorafenib or Products for use by such Third Party in Combination Studies so long as such Combination Studies are not Local Studies, (x) in the event Array determines to supply any Third Party with Binimetinib, Encorafenib or Products for use by such Third Party in any global Combination Studies sponsored by such Third Party that includes the Ono Territory, Array shall notify Ono of such supply of Binimetinib, Encorafenib or Products to such Third party promptly following Array’s decision to supply such Third Party, (y) Array shall have no obligation to prevent Third Parties from acquiring Product on the open market for use in conducting Local Studies, and (z) the restrictions in this Section 4.5(b) shall not apply to PFM, and shall immediately terminate upon a Change in Control of Array; provided however that, any Combination Study shall be conducted subject to appropriate firewall procedures as described in Section 18.10 to segregate such activities (and the personnel conducting such activities) from the activities performed by or on behalf of Array pursuant to this Agreement, to ensure that [ * ] is used in connection with such Combination Study in case of Change in Control of Array.
(c) Ono acknowledges that under the PFM Agreement, PFM has a right under certain circumstances to conduct Clinical Studies in the Ono Territory. Without limiting PFM’s rights under the PFM Agreement, Array agrees that in the event that PFM submits an Additional Development Proposal (as defined in the PFM Agreement) that would utilize clinical sites in the Ono Territory, Array shall submit such proposal to the JDRC as a Joint Clinical Study Proposal under Section 4.4(a) and provide Ono the opportunity to include the Clinical Study described in such Additional Development Proposal as an Approved Clinical Study under this Agreement.
4.6 Regulatory Submissions and Marketing Approvals.
(a) Regulatory Responsibilities. Ono or its Affiliates shall be responsible for seeking and attempting to obtain all Marketing Approvals for the Products in the Field in the Ono Territory, and Array or its Affiliate or licensees shall be responsible for seeking and attempting to obtain all Marketing Approvals for the Products in the Field in the Array Territory.
(b) INDs. Except for any INDs filed by Array in the Ono Territory (i) with respect to an Approved Clinical Study for which the Parties agree in the applicable Joint Development Plan that the applicable Regulatory Filing will be owned by Array, and/or (ii) with respect to Clinical Studies conducted by Array in one or more countries of the Ono Territory pursuant to Section 4.5 above, which Regulatory Filings, the “Array Regulatory Filings”, shall be owned by Array, Ono shall be responsible, at its expense, for filing, obtaining and maintaining, and shall own, all INDs for the Product in the Ono Territory.