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|EXECUTION VERSION || ||Confidential|
1.20 Government Authority means any federal, state, national, state, provincial or local government, or political subdivision thereof, or any multinational organization or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body).
1.21 IND means any investigational new drug application, clinical trial application, clinical trial exemption or similar or equivalent application or submission for approval to conduct human clinical investigation filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
1.22 Invention shall mean any process, method, composition of matter, article of manufacture, discovery or finding, patentable or otherwise, that is invented as a result of a Party exercising its rights or carrying out its obligations under this Agreement, whether directly or via its Affiliates, agents or independent contractors, including all rights, title and interest in and to the intellectual property rights therein.
1.23 Know-How means any non-public information in any tangible or intangible form, including discoveries, improvements, modifications, processes, methods, protocols, formulas, data, inventions, know-how and trade secrets, patentable or otherwise.
1.24 Law means any federal, state, local, foreign or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order by any Government Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.
1.25 Licensed Know-How means all Know-How that (a) is Controlled by Eisai or its Affiliates as of the Effective Date or thereafter during the Term of this Agreement, and (b) relates to the Compound and/or Product and (c) (i) is necessary for the Development, manufacture and/or Commercialization of the Compound and/or Product, (ii) was generated and used by or on behalf of Eisai in the course of developing or manufacturing the Compound and/or Product and/or (iii) was provided by Eisai to Roivant in writing (including anything provided electronically in the data room or otherwise) in connection with Roivants diligence of the Compound and/or Product prior to the Effective Date.
1.26 Licensed Patents means (a) the patent applications and patents set forth in Exhibit B attached hereto, and (b) any and all corresponding foreign patents and patent application to the foregoing patents or patent applications, whether now existing or hereafter filed; (c) any provisionals, substitutions, divisionals, reissues, reexaminations, renewals, continuations, continuations-in-part, substitute applications, inventors certificates, extensions, and supplemental certificates arising from, claiming priority to, claiming priority from, or based upon, any of the foregoing patents or patent applications, and (d) any patents issuing from any of the foregoing patent applications; in each case that are related to the Compound or Product and are Controlled by Eisai or its Affiliates as of the Effective Date or thereafter during the Term.
1.27 Licensed Technology means the Licensed Know-How and Licensed Patents.
1.28 MAA or Marketing Authorization Application means an application to the appropriate Regulatory Authority for approval to market a Product (but excluding Pricing Approval) in any particular jurisdiction and all amendments and supplements thereto, including NDA filed with the FDA in the U.S.
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.