|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.
shall exercise such rights, at Ono’s expense, on behalf of Ono and fully report the results thereof to Ono.
9.4 Commercial Supply.
(a) Ono shall have the right (but not the obligation) to Manufacture and/or package, or engage a Subcontractor to Manufacture, Ono’s requirements of particular Materials (e.g., Ono’s requirements of Drug Substance or Ono’s requirements of Drug Product of a particular Product) related to any Product for the Ono Territory. Promptly following Ono’s request, Array shall transfer, or cause to be transferred, to Ono or such Subcontractor all Array’s Know-How that is necessary, useful or actually used for such Manufacture, packaging and/ or testing and release of Materials (and the cost of such transfer of Array Know-How shall be borne by Ono), and shall make personnel of Array reasonably available to assist Ono and/or its contractor in implementing the Array Know-How necessary to Manufacture and/or control and release such Materials. Upon completion of the technology transfer enabling Ono to Manufacture the Materials for the Ono Territory under the Marketing Approval, Array’s supply obligations under Sections 9.2 and 9.3(b) with respect to such Materials shall terminate and Ono shall assume all supply-related liability with respect to such Materials which it Manufactures or sources from Subcontractor.
(b) Without limiting the foregoing, Ono shall have the right to obtain from Array Ono’s commercial requirements of Materials for the Ono Territory. Upon Ono’s request, the Parties shall enter into a commercial supply agreement (a “Supply Agreement”) and commercial quality agreement (a “Quality Agreement”) on commercially reasonable terms documenting the arrangement pursuant to which:
(i) Array shall supply Ono’s reasonable requirements for Materials for the Ono Territory, which Supply Agreement shall contain forecasting and ordering procedures (including lead times), product specifications, delivery terms and other appropriate provisions mutually acceptable, and any customary terms, which terms shall in all cases be consistent with Array’s contractual arrangements with its Subcontractors, and taking into account the regulatory requirements imposed on Ono as the holder of the Marketing Approval.
(ii) Array has made arrangements with Novartis to transfer and validate at no cost to Ono all technology reasonably necessary for the manufacturing and analytical testing of the Materials by [ * ] so that commercial quantities of Materials and can be supplied to Ono and released for the Ono Territory;
(iii) Materials supplied by Array to Ono for commercial sale of the Products shall be charged to Ono in an amount equal to (A) [ * ] of Array’s manufacturing cost to the extent that Array or its