Common use of For Safety or Regulatory Concerns Clause in Contracts

For Safety or Regulatory Concerns. Astellas may terminate this Agreement on a Product-by-Product basis effective upon thirty (30) days’ prior written notice to Ambit at any time referencing this Section 9.2.2 and providing Ambit with all clinical data supporting such termination together with a detailed written explanation of why Astellas believes that the Adverse Safety/Tox Results (as defined below) justify discontinuing all development and Commercialization hereunder. For purposes of the foregoing, “Adverse Safety/Tox Results” means, with respect to a particular Product, results from activities hereunder that provide a reasonable basis for the discontinuance by Astellas of all further development or Commercialization of such Products for use in the Field because the risk profile of such Product makes it unlikely that Regulatory Approval within the Field can be obtained or maintained for such Product in any of the U.S., EU or Japan. In the event that Ambit disputes Astellas’s decision to terminate in accordance with this Section 9.2.2, the Parties shall promptly refer such dispute for resolution pursuant to Section 10.7 and, if Astellas desires to terminate this Agreement for convenience regardless of the outcome of the dispute resolution procedure, Astellas shall provide Ambit with written notice of such intent, in which case Astellas shall be deemed to have provided Ambit with notice of termination pursuant to Section 9.2.1 as of the date that Astellas provided notice of its intent to terminate pursuant to this Section 9.2.2. Termination of this Agreement shall be effective upon the earlier to occur of (A) the expiration of the notice period provided in Section 9.2.1 and (B) conclusion of the dispute resolution process in Astellas’s favor. Without limitation of the foregoing, in the event that Astellas terminates this Agreement pursuant to this Section 9.2.2 with respect to the Lead Product, it shall have the right to terminate this Agreement simultaneously with respect to all Products by so specifying in writing to Ambit.