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of bipolar depression associated with bipolar and related disorders and/or depressive disorders as defined in DSM-V in effect as of the Effective Date, or (b) D-cycloserine (including metabolites and structural variants thereof) for treatment of all types of bipolar, depressive, and/or anxiety disorders as defined in DSM-V in effect as of the Effective Date, and/or symptoms thereof.
For the avoidance of doubt, fixed dose combination of D-cycloserine and Lurasidone, such as “NRX-101”, is a product within the Field under sub-sections (a) and (b) above.
1.4 “Herzog Hospital Study” shall mean the investigator (Prof. Uriel Heresco-Levy) -initiated randomized add-on trial of high-dose D-cycloserine for treatment-resistant depression carried out at Herzog Hospital.
1.5 “Licensed Intellectual Property” shall mean the Licensed Patents and the Licensed Know-How.
1.6 “Licensed Know-How” shall mean the de-identified data collected in the course of the Herzog Hospital Study (the “Study Data”) at least a portion of which has been supplied to the Licensee, to the extent located by Licensor prior to the execution of this Agreement, and all scientific, clinical or other information, knowledge and know-how and materials that may be developed in Licensor’s laboratories or facilities or by any employee or contractor of Licensor prior to, on or after the Effective Date and during the Term that have specific application to the development of any Licensed Product and/or to the Licensed Patents, including but not limited to data, reports, and materials from preclinical or clinical studies, know-how and information necessary and/ or useful for the research, development, manufacture or commercialization of Licensed Product, in each case owned or controlled by Licensor or any of its Affiliates.
1.7 “Licensed Patents” shall include those patents and patent applications set forth in Part I of APPENDIX A hereto (the “Existing Patents”), and such additional patents and patent applications as may from time to time be added to APPENDIX A via an amendment thereto as provided under Paragraph 13.2 hereof.
1.8 “Licensed Product” shall mean any Product as specified in (a) or (b) in the definition of Field herein.
1.9 “Milestone Payments” shall mean the payments payable by Licensee to Licensor pursuant to paragraph 3.2(a) below.
1.10 “Products” shall mean any article, composition, apparatus, device, kit, substance, chemical, composition or formulation or any other material, process or service.
1.11 “Revenues” shall mean income of Licensee from sales of Licensed Products by Licensee and its Affiliates (but not by Sublicensees), calculated as gross receipts from sales of Licensed Products in the Territory during the Term less the sum of the following:
(a) discounts actually allowed and granted (including, without limitation, cash
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