Common use of Safety or Efficacy Clause in Contracts

Safety or Efficacy. If at any time during the Term: (i) the Party with responsibility for filing an application for Regulatory Approval hereunder ("Filing Party") decides not to file an application for Regulatory Approval in any Major Subterritory or decides to withdraw such application due to documented adverse reactions or other safety issues with the Product or the Product's lack of efficacy or limited efficacy (collectively, "Safety or Efficacy Issues"); (ii) the Filing Party's application(s) for Regulatory Approval in any Major Subterritory is rejected due to Safety or Efficacy Issues; (iii) the Filing Party's application(s) for Regulatory Approval in any Major Subterritory is subsequently withdrawn because of Safety or Efficacy Issues; (iv) the Product is withdrawn or recalled from the market in any Major Subterritory because of Safety or Efficacy Issues; or (v) at any time during the period from the Effective Date to the effective date of API's assignment of the U.S. NDA for the Product to Abboxx, Xxboxx xxxsonably believes documented Safety or Efficacy Issues exist and Abbott has so notified API in writing, then Abbott may, at its option, terminate this Agreement upon thirty (30) days prior written notice to API. Abbott may, at its option, exercise its right of termination under this Section 16.4(a) on a country-by-country basis, and, if Abbott does so, Abboxx'x xxxmination notice shall specify the country or countries of the Territory affected.

Safety or Efficacy. If at any time during the Term: (i) the Party with responsibility for filing an application for Regulatory Approval hereunder ("Filing Party") decides not to file an application for Regulatory Approval in any Major Subterritory or decides to withdraw such application due to documented adverse reactions or other safety issues with the Product or the Product's lack of efficacy or limited efficacy (collectively, "Safety or Efficacy Issues"); (ii) the Filing Party's application(s) for Regulatory Approval in any Major Subterritory is rejected due to Safety or Efficacy Issues; (iii) the Filing Party's application(s) for Regulatory Approval in any Major Subterritory is subsequently withdrawn because of Safety or Efficacy Issues; (iv) the Product is withdrawn or recalled from the market in any Major Subterritory because of Safety or Efficacy Issues; or (v) at any time during the period from the Effective Date to the effective date of API's assignment of the U.S. NDA for the Product to AbboxxXxxxxx, Xxboxx xxxsonably Xxxxxx reasonably believes documented Safety or Efficacy Issues exist and Abbott has so notified API in writing, then Abbott may, at its option, terminate this Agreement upon thirty (30) days prior written notice to API. Abbott may, at its option, exercise its right of termination under this Section 16.4(a) on a country-by-country basis, and, if Abbott does so, Abboxx'x xxxmination Xxxxxx'x termination notice shall specify the country or countries of the Territory affected.