|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.
(b) For purposes of this Article 9, “Drug Substance” shall mean active ingredient containing Binimetinib or Encorafenib that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient; and “Drug Product” shall mean a finished dosage form containing Drug Substance.
9.2 Related Substance Supply. Upon Ono’s written request, Array agrees to supply to Ono from available quantities in its possession (i.e., quantities not otherwise required by Array in its own development and commercialization efforts) certain related materials (e.g., reference standard, internal standard and impurities) necessary for Ono to conduct non-clinical studies, clinical studies, including, but not limited to analytical test method development and/or validation, for regulatory submissions or Commercialization in the Ono Territory, at Array’s manufacturing cost or the purchase price of Array from Array’s Subcontractors. For clarity, the forgoing supply obligations not apply to materials that are generally commercially available.
9.3 Clinical Supply. The Parties shall establish as soon as practicable following the Effective Date procedures for the supply of Materials to Ono for use in performing Ono’s Development activities under Development Plan and any Joint Development Plans that may subsequently be agreed to by the Parties, and the Parties shall enter into a clinical supply agreement and quality agreement within three (3) months of the Effective Date pursuant to which:
(a) Array shall procure Materials on behalf of and as reasonably requested in writing by Ono, which Materials will be supplied to Ono at transfer price equal to: (i) Array’s manufacturing cost to the extent that Array or its Affiliate(s) Manufacture such Materials itself, or (ii) the purchase price paid by Array for such Materials to the extent that Array elects to have such Materials Manufactured by a Subcontractor. The clinical supply agreement shall contain forecasting and ordering procedures (including lead times), product specifications, delivery terms and other customary terms, which terms shall in all cases be consistent with Array’s contractual arrangements with its Subcontractors;
(b) Array may place orders for Materials with its Subcontractors on Ono’s behalf, or, subject to Ono and the Subcontractors entering into an agreement or other arrangement therefor, Array shall arrange with such Subcontractors for Ono to place such orders, for shipment to Ono and for Ono to pay for such Materials directly to the particular supplier. Array shall not require Ono to place orders directly with a Subcontractor if such Subcontractor is unwilling to fulfill such orders on terms as favorable to Ono as the terms such Subcontractors have extended to Array.
(c) Array shall use Diligent Efforts to secure for Ono the inspection rights from Array’s Subcontractors for Materials. In the event Array is unable to secure such inspection rights from any of its Subcontractors, Array agrees to secure such rights for itself and, if requested by Ono, Array