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|Confidential || ||EXECUTION VERSION|
1.3 Affiliate means, with respect to a Party, any Person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with that Party, but for only so long as such control exists. For the purpose of this definition, control (including, with correlative meaning, the terms controlled by and under common control) means (a) to possess, directly or indirectly, the power to direct the management or policies of an
entity, whether through ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) direct or indirect beneficial ownership of more than fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital or other equity interest in such entity.
1.4 Aggregate Annual Net Sales has the meaning set forth in Section 8.4(a) (Royalty Payments).
1.5 Applicable Laws means the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative codes, guidances, ordinances, judgments, decrees, directives, injunctions, orders, permits (including MAAs) of or from any court, arbitrator, Regulatory Authority or Governmental Authority having jurisdiction over or related to the subject item.
1.6 Auditor has the meaning set forth in Section 8.11 (Audit Dispute).
1.7 Business Day means a day other than a Saturday, Sunday or a bank or other public holiday in Basel or New York.
1.8 Calendar Quarter means each respective period of three (3) consecutive months ending on March 31, June 30, September 30, and December 31.
1.9 Calendar Year means each respective period of twelve (12) consecutive months ending on December 31.
1.10 CFR means the U.S. Code of Federal Regulations.
1.11 CIOMS means the Council for International Organizations of Medical Sciences.
1.12 Claims means all Third Party demands, claims, actions, proceedings and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, legal costs and other expenses of any nature.
1.13 CMC means chemistry, manufacturing, and controls.
1.14 CMO means contract manufacturing organization.
1.15 Combination Product means any Licensed Product comprising a fixed-dose combination of: (a) a Proprietary Drug and (b) at least one Other Active.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.