preparation or administration), or that would be necessary or reasonably useful for the Development, manufacture, use and/or Commercialization of Compound and/or Products in the Field as permitted under this Agreement. Subject to and to the extent as provided in Section 17.8 (Assignment), the use of Affiliate in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Partys or such Third Partys Affiliates acquisition of RAPT in a Change of Control Transaction. As of the Effective Date, the RAPT Patent Rights in the Territory include the Patents listed in Exhibit B.
1.106 RAPT Technology means the RAPT Patent Rights, RAPT Know-How and RAPT Materials.
1.107 Receiving Party has the meaning set forth in Section 12.1 (Confidentiality).
1.108 Regulatory Approval means with respect to a country, extra-national territory, province, state, or other regulatory jurisdiction, any and all approvals, licenses, registrations or authorizations of any Governmental Authority necessary in order to commercially distribute, sell, manufacture, import, export or market a product in such country, state, province, or some or all of such extra-national territory or regulatory jurisdiction[***].
1.109 Regulatory Authority means any Governmental Authority, including any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, MFDS and NMPA, in each case involved in the granting of Regulatory Approval or Pricing Approval for the Product.
1.110 Regulatory Data means any and all research data, pharmacology data, CMC Data, Safety Data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with Regulatory Filings and Regulatory Approvals for the Product (including any applicable drug master files or similar documentation).
1.111 Regulatory Filings means, with respect to the Product, any submission to a Regulatory Authority of any appropriate regulatory application specific to Products, including all INDs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents. Regulatory Filings includes any Marketing Approval Application and application for Pricing Approval.
1.112 Regulatory Materials means regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Governmental Authority that are necessary or reasonably desirable in order to Develop, manufacture or Commercialize a Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, MAAs and NDAs.
1.113 Related Party shall mean Hanmi and its Affiliates and their respective Sublicensees (and such Sublicensees Affiliates) of one or more Products. For clarity, Related Party shall not include any distributors (other than Sublicensees), wholesalers or the like unless such entity is an Affiliate of Hanmi.
1.114 Research Plan has the meaning set forth in Section 3.1(a) (Research Program Costs).
1.115 Research Program has the meaning set forth in Section 3.1(a).
1.116 Right of Reference means the right of reference or use defined in 21 CFR 314.3(b), or its equivalents outside the United States, and includes the right to allow the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Filings (and any data contained or referenced therein) filed with such Regulatory Authority.
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