definiens: ( as thatterm is defined in 21 C.F.R. § 314.3(b ), as amended from time to time ), and any non - United States equivalents ( includingArticle 10c of Directive 2001/83 / EC, as amended ), to any and all data contained or referenced in- 16 - any Regulatory Approvals and other Regulatory Documentation relating to all Licensed Products, including all reports, correspondence and conversation logs, and Licensor shall provide appropriate notification of Licensee ’s access and referencerights to the Regulatory Authorities, including an informed consent letter under Article 10c of Directive 2001/83 / EC asamended ; 2.1.6 subject to Section 4.10, a non - exclusive license, with the right to grant sublicenses in accordance with Section 2.3,under the Licensor Patents, the Licensor Know - How, the Joint Patents ( to the extent Controlled by Licensor ) and the JointKnow - How ( to the extent Controlled by Licensor ) to Manufacture or, subject to Section 2.3 hereof, to have Manufactured theLicensed Compound and the Licensed Products anywhere in the world for sale in the Licensee Territory ; and 2.1.7 a non - exclusive license, with the right to grant sublicenses in accordance with Section 2.3, under the LicensorPatents, the Licensor Know - How, the Joint Patents ( to the extent Controlled by Licensor ) and the Joint Know - How ( to theextent Controlled by Licensor ) to Develop the Licensed Compound and the Licensed Products anywhere in the world for salein the Licensee Territory