definiens: means ( a ) the FDA in t he United States or ( b ) any equivalent agency or governmental authority in any country or other juri sdiction outside the United States that has respons ibility for granting any licenses or approvals necessary for th e marketing and/or sale of a Licensed Product in su ch country or other jurisdiction ( including, without limitatio n, any supra - national agency such as the ( EMA ) ) . ” 3 . Section 3.4(b ) of the Agreement is hereby deleted a nd restated in its entirety as follows : ( b ) If LICENSEE fails to perform any of its obligations specified in Paragraphs 3.4(a)(i)- ( vii ), then : ( i ) UNIVERSITY shall have the right and option to either terminate this Agreement or change LICENSEE ’s exclusive license to a nonexclusive lice nse ; ( ii ) Notwithstanding Paragraph 3.4(b)(i ), in the event that LICENSEE believes in good faith that there exists a significant issue related to the saf ety and/or efficacy of a Licensed Product for treat ment of any indication, or that further development of a Licens ed Product is not commercially viable in such indic ation, then LICENSEE shall so notify UNIVERSITY in writing, and upon University ’s written agreement, LICENSEE shal l have the right to delay or discontinue development of such Licensed Product for the treatment of such indication for up to six ( 6 ) months . In the event that LICENSE E does not receive a response from UNIVERSITY withi n thirty ( 30 ) days of LICENSEE ’s written notice, UNIV ERSITY shall be deemed to have provided its written agreement upon the end of such thirty ( 30 ) day peri od . If, after six ( 6 ) months, LICENSEE does not res ume development of such Licensed Product for that parti cular indication ( e.g., cystinosis ), UNIVERSITY sha ll have the right and option, from and after the date of wr itten notice from UNIVERSITY : ( A ) to terminate this Agreement solely with respect to such indication, i n which event, such indication shall be deemed to b e excluded from the definition of ; or ( B ) to change LI CENSEE ’s exclusive license to a non - exclusive licen se solely with respect to such indication ; and ( iii ) Notwithstanding Paragraph 3.4(b)(i ), from and after the date on which LICENSEE first obtains regulatory approval from a Regulatory Autho rity for any indication ( e.g., cystinosis ), UNIVERS ITY would not exercise its rights under Paragraph 3.4(b ) ( i ) with respect to such indication, or to change LICENSEE ’s exclusive license to a non - exclusive license for su ch indication, as a result of LICENSEE ’s failure to satisfy its obligations under Paragraph 3.4(a ) with respect to a different indication, which is not yet approved f or sale . ” These rights, if exercised by UNIVERSITY, supersede the rights granted in Article 2