1.1.12 “Royalty Period” shall mean each calendar year during the Royalty Term; provided that the first Royalty Period of this Agreement shall begin on the date of the first commercial sale and end on the last day of the calendar year in which the first commercial sale occurs.
1.1.13 “Royalty Term” shall mean, on a Licensed Product-by-Licensed Product and country-by-country basis, the period commencing on the first commercial sale of such Licensed Product in such country in the Licensed Territory and ending on the last to occur of: (a) the last to expire of the Licensed Patents covering such Licensed Product in such country; or (b) the expiration of Market Exclusivity (as defined below).
1.1.14 “Technical Information” shall mean: (a) research and development information, unpatented inventions, and know-how pertaining to the Licensed Patents created by the Innovators of the Research Institute known as of the Effective Date or learned or developed during the Term of this Agreement; and (b) tangible materials pertaining to the Licensed Patents made by the Innovators in amounts selected by Research Institute in consultation with the Licensee and in amounts not so little as to unduly burden Licensee in its performance under this Agreement; each solely to the extent Research Institute has determined, in its sole discretion, to provide to Licensee hereunder.
1.1.15 “Term” shall have the meaning set forth in Section 11.1.
1.1.16 “Market Exclusivity” shall mean any orphan drug-based exclusive marketing rights conferred by any Regulatory Authority with respect to a Licensed Product in a country in the Licensed Territory, including orphan drug exclusivity rights conferred by the U.S. Food and Drug Administration (FDA) or any rights equivalent thereto conferred by any Regulatory Authority in any other country in the Licensed Territory.
1.2 Interpretation. Each definition in this Agreement includes the singular and the plural. References to any statute or regulation mean such statute or regulation, as amended from time to time, and include any successor legislation, regulations, guidelines and policies promulgated therefrom. The headings to the Articles and Sections are for convenience of reference and shall not affect the meaning or interpretation of this Agreement. The Exhibits attached hereto are hereby incorporated by reference into and shall be deemed a part of this Agreement. The term “including” shall mean “including but not limited to.”
LICENSE GRANTS AND RESERVATION OF RIGHTS
2.1.1 Patent License. Subject to the terms and conditions of this Agreement and Licensee’s compliance therewith, Research Institute and Ludwig grant to Licensee an exclusive, non-transferable (except a transfer to an Affiliate or as otherwise permitted herein), sublicensable through multiple tiers (in accordance with Section 2.1.4) license in the Field of Use in the Licensed Territory under the Licensed Patents to make, have made (only Licensed Products of Licensee, its Affiliates and sublicensees for sale by or on behalf of Licensee, its Affiliates