Reversion Right. 6.1 Durata shall use reasonable efforts to file, or to have its Affiliate, licensee or designee file, a Regulatory Approval Application for the Product in Japan within [**] months after the later of (a) the filing by Durata, its Affiliate, licensee or designee of a Regulatory Approval Application for the Product with the FDA and (b) the filing by Durata, its Affiliate, licensee or designee of a Regulatory Approval Application for the Product with the EMA (the “Reversion Term”); provided, however, that (1) the obligations under this Sections 6.1 and Sections 4, 6.2, 6.3 and 6.4 shall terminate and Durata shall have no obligation to file or have filed a Regulatory Approval Application for the Product in Japan if, at any time, an External Termination Factor or Safety Concern arises, and (2) if, at any time, an External Delay Factor arises, the period set forth in this Section 6.1 shall be automatically extended by the number of days between the date on which such External Delay Factor arises and the date on which such External Delay Factor has been completely eliminated or resolved. For the avoidance of doubt, the Parties agree and acknowledge that Durata shall be under no obligation to seek or obtain Regulatory Approval for the Product in Japan. 6.2 If Durata fails to fulfill its obligation pursuant to Section 6.1, then, as RaQualia’s sole remedy and Durata’s exclusive liability, RaQualia may regain the rights to the Product in Japan on substantially the same terms as in the Marketing Rights Agreement and the Parties shall negotiate in good faith the terms of such an agreement (including any necessary amendments to this Agreement), and, upon RaQualia’s written request to regain such rights, Durata’s obligations under Sections 4, 6.1, 6.3 and 6.4 shall automatically terminate. 6.3 If, at any time, Durata notifies RaQualia in writing that Durata desires to terminate its obligations and RaQualia’s rights under Sections 4, 6.1, 6.2 and 6.4, then, as RaQualia’s sole remedy and Durata’s exclusive liability, RaQualia may regain the rights to the Product in Japan on substantially the same terms as in the Marketing Rights Agreement and the Parties shall negotiate in good faith the terms of such agreement (including any necessary amendments to this Agreement), and, upon RaQualia’s receipt of Durata’s notice of such termination, RaQualia’s rights and Durata’s obligations pursuant to Sections 4, 6.1, 6.2 and 6.4 shall automatically terminate. 6.4 Once each calendar year, starting in 2011 and prior to the filing by Durata, its Affiliate, licensee or designee of a Regulatory Approval Application for the Product in Japan, RaQualia shall have the right to require Durata to provide an annual report on the status of development of the Product for Commercialization in Japan, including an estimated development schedule.
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Sources: Rights Transfer Agreement, Rights Transfer Agreement (Durata Therapeutics, Inc.)