|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.
1.44 “Party” means Array or Ono, individually; and “Parties” means Array and Ono, collectively.
1.45 “Patent(s)” means any patents and patent applications, together with all additions, divisions, continuations, continuations-in-part, substitutions, reissues, re-examinations, registrations, patent term extensions, supplemental protection certificates, and renewals of any of the foregoing.
1.46 “Ono Know-How” means all scientific, medical, technical, marketing, regulatory, market access and other information (including clinical data and other related information generated in compliance with CDISC standards) relating to Binimetinib, Encorafenib and/or a Product (including the Data), that (a) exists as of the Effective Date or is developed, acquired or otherwise comes within the Control of Ono during the term of this Agreement and (b) in each case is actually used by Ono in the Development, Manufacturing or Commercialization of a Product, and is needed by or reasonably useful to Array in order for Array to exercise its rights (including the conduct of activities directed towards Developing the Product for Commercialization outside the Ono Territory and/or the Commercialization of the Product outside the Ono Territory) or perform its obligations under this Agreement. Notwithstanding the foregoing or Section 1.18 (Data) above, Ono Know-How shall in any case include all such items that are generated by or under authority of Ono, or any of its Affiliates or Sublicensees, in connection with Development, Manufacturing and/or Commercialization of the Product during the term of this Agreement.
1.47 “Ono Territory” means Japan and Republic of Korea (“Korea”).
1.48 “Post-Approval Marketing Clinical Study” means a Clinical Study that is a marketing study, epidemiological study, pharmacoeconomic study, or post-marketing surveillance study of a Product, in each case that is conducted after Marketing Approval has been obtained in the applicable territory and that is not intended for use as a basis for obtaining Marketing Approval (e.g., for a further Indication, label expansion or otherwise) with respect to the Product and that is not being conducted as a commitment made to a Regulatory Authority as a condition of, or in connection with obtaining or maintaining, a Marketing Approval).
1.49 “Pricing and Reimbursement Approval” means, with respect to any country or jurisdiction in the Ono Territory in which Governmental Authorities determine the pricing at which the Product will be reimbursed, the approval, agreement, determination or decision by the applicable Governmental Authorities establishing the pricing and reimbursement status for the Product.
1.50 “Product” means shall mean any pharmaceutical product containing, as an active ingredient, one or more of Binimetinib or Encorafenib, including, without limitation, any Combination Product.