A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.
1.101 Regulatory Exclusivity means, with respect to each Product in any jurisdiction in the Territory, any period of data, market or other regulatory exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such jurisdiction that confers exclusive marketing rights with respect to such Product in such jurisdiction or prevents another Person from using or otherwise relying on any data supporting the approval of the Marketing Authorization Application with respect to such Product in such jurisdiction without the prior written consent of the Marketing Authorization Application-holder, as applicable, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.
1.102 Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, discussion/meeting minutes, registrations, Regulatory Approvals and/or other filings made or related to, received from or otherwise conducted with a Regulatory Authority that are necessary in order to Develop, Manufacture, Package, obtain marketing authorization, market, sell or otherwise Commercialize the Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, presentations, responses, and applications for other Regulatory Approvals.
1.103 Remedial Action has the meaning set forth in Section 5.7 (Remedial Actions).
1.104 Respective Territory means, in the case of KHK, the Territory, and in the case of MEI, all countries of the world outside the Territory.
1.105 Royalty Term has the meaning set forth in Section 8.4(b) (Royalty Term).
1.106 r/r has the meaning set forth in Section 4.3(a) (Development Diligence).
1.107 Sole Inventions has the meaning set forth in Section 9.1(b) (Ownership of Inventions).
1.108 Sublicense means a license or sublicense to Develop, make, use, import, promote, offer for sale or sell any Compound or Product.
1.109 Sublicensee means a Third Party or Affiliate to whom KHK has granted a Sublicense in accordance with the terms of this Agreement.
1.110 Supply Items has the meaning set forth in Section 6.1 (Development Supply).
1.111 Tax or Taxes means any (a) all federal, provincial, territorial, state, municipal, local, foreign or other taxes, imposts, rates, levies, assessments and other charges in the nature of a tax (and all interest and penalties thereon and additions thereto imposed by any Government Authority), including without limitation all income, excise, franchise, gains, capital, real property, goods and services, transfer, value added, gross receipts, windfall profits, severance, ad valorem, personal property, production, sales, use, license, stamp, documentary stamp, mortgage recording,