Definition of Post-Approval Failure


Post-Approval Failure means: (a) a mandatory withdrawal or recall of a Product by a Regulatory Authority, or (b) any voluntary withdrawal or recall of a Product in a Major Ex-U.S. Market country that arises from risks associated with a serious adverse health consequence or death reported to a Regulatory Authority anywhere in the Territory. Notwithstanding the foregoing, any such recall that results primarily from Licensee's or its Affiliate's or Sublicensee's gross negligence, willful misconduct, or failure to comply with Applicable Law in the Development, Manufacture or Commercialization of a Product in the Territory shall not be considered a Post-Approval Failure for purposes of this Agreement.

Examples of Post-Approval Failure in a sentence

If a Post-Approval Failure occurs in the Territory, Licensee may, at its option, terminate the Agreement in its entirety; provided, that written notice of termination must be delivered to POZEN within ***(***) days following such Post-Approval Failure.
If a Post-Approval Failure occurs anywhere in the Territory, Licensee may, at its option, terminate the Agreement either in its entirety, or in the country where the Post-Termination Failure occurred only, or on a country-by-country basis with respect to one or more countries of the Territory; provided, that written notice of termination must be delivered to POZEN within *** (***) days following such Post-Approval Failure.
If a Post-Approval Failure occurs in the Territory, Licensee may, at its option, terminate the Agreement in its entirety; provided, that written notice of termination must be delivered to POZEN within [ *** ] ([ *** ]) days following such Post-Approval Failure.
If a Post-Approval Failure occurs in the Territory, Licensee may, at its option, terminate the Agreement in its entirety; provided, that written notice of termination must be delivered to POZEN within sixty (60) days following such Post-Approval Failure.