definiens: as used in this Paragraph 3.01 is meant@.B 's determination that continued clinical development of PRODUCT for treatment of traumatic brain injury is wam.n§it outlined in the OUTLINE DEVELOPMENT PLAN ( as such may be modified by SB in accordance with Paragraph S.Ol ) ; ( e ) by the terms and as used in this Pangraph 3.01 is meant the FDA 's acceptance of an NDA filed by or on behalf of SB for approval to market PRODUCT in the U.S' . A. for the specified indication ; ( f ) by the terms and as used in this Paragraph 3.01 is meant the filing by or on behalf of SB of a Marketing Authorization Application ( MAA ) or its equivalent outside of Europe for approval to market PRODUCT in the first of Japan, the United Kingdom, France, Germany, Spain or Italy ( Major Market ) of the treatmenfof the specified indication ; ( g ) by the terms and as used in this Paragraph 3.01 is meant the FDA 's approval of an NDA filed by or on behalf of SB for marketing of PRODUCT in the U.S.A. for the treatment of the specified indication ; ( h ) by the terms and as used in this Paragraph 3.01 is meant the first receipt by SB of all requisite marketing and pricing approvals required to market PRODUcr for the specified indication in a Major Market ; and ( i ) in the event SB decides to develop PRODUCT for the treatment andlor prophylaxis of an indication unrelated to the treatment andlor prophylaxis of any neurological disorder, SB shall pay to CORTECH an additional sum of money in installment payments within thirty ( 30 ) days of the occurrence of the First MAA Filing in Major Market for such indication and NDA u:\data\c : ortc : ch.doc ( execution ~ Indicates portions of text that have been omitted . A separate filin2 of such omitted text has been made with the Commission as P : lge 6 Acceptance for such indication, the amount of such installment payments to be : negotiated by the parties, in good faith, prior to the start of Phase ill clinical development of PRODUCT for such indication, provided that in no event shall the treatment and/or prophyla:'(is of migraine or spinal cord injury be deemed to be a neurological disorder