1.1.3 “Field of Use” shall mean for therapies and treatment of Rett Syndrome (“Rett”) in human use only.
1.1.4 “Net Sales” shall mean the gross amount received by Licensee or any sublicensee, including its Affiliates, for the sale, transfer or other disposition of Licensed Products to a third party for end use (including where the Affiliate or sublicensee is the end user) less the following to the extent documented as attributable to the Licensed Products: ****. In the event Licensed Products are put into use, sold, transferred or otherwise disposed of other than in an arms-length transaction, or if Licensee, including its Affiliates or its sublicensees, receive consideration other than cash for Licensed Products, then the invoiced amount shall be calculated ****.
1.1.5 “Innovators” shall mean ****.
1.1.6 “License Year” shall mean each calendar year in which this Agreement is in effect, provided that the first License Year shall begin on the Effective Date of this Agreement and run until December 31 of the same calendar year and the final License Year shall end on the date of expiration or termination of this Agreement.
1.1.7 “Licensed Patents” shall mean those patents and/or patent applications identified in Exhibit A, all U.S., PCT, and foreign applications claiming priority thereto, including divisionals, continuations, or continuations-in-part (to the extent that the claimed subject matter of such continuations-in-part is disclosed in the parent Licensed Patent) all patents issuing thereon, reissues, reexaminations, and any extensions thereof or supplementary protection certificates allowed thereon; provided, however, in each case only to the extent of subject matter claimed that is fully disclosed and enabled by the disclosures in Exhibit A to satisfy 35 U.S.C. §112.
1.1.8 “Licensed Products” shall mean any product or process, including a service: (a) that is claimed in whole or in part by the Licensed Patents, or the use or manufacture is claimed in whole or in part by the Licensed Patents; (b) the development, manufacture, use, sale or importation of which incorporates or is derived from the Technical Information; or (c) that meets the criteria of both (a) and (b).
1.1.9 “Licensed Technology” shall mean the Licensed Patents and the Technical Information.
1.1.10 “Licensed Territory” shall mean worldwide.
1.1.11 “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.
1.1.12 “Party” shall mean either Licensee or Children’s, and “Parties” shall mean both Licensee and Children’s.
1.1.13 “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.
1.1.14 “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