Cessation of Supply; Supply Failure; Backup Supplier. In the event that ENDOCEUTICS intends to cease Manufacturing PRODUCT (i.e., ENDOCEUTICS no longer intends to Manufacture PRODUCT, itself or through a CMO, for itself or its customers for sale anywhere in the world), then ENDOCEUTICS shall notify AMAG in writing at least [***] in advance (or such shorter period of time as the Parties may mutually agree) (the “Cessation Notice”). In the event that a Supply Failure occurs or ENDOCEUTICS reasonably believes that a Supply Failure could occur, or if ENDOCEUTICS anticipates a delay or shortfall in the [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED Manufacture and supply of PRODUCT hereunder due to a Force Majeure, CMO failure or implementation of a new regulatory requirement, ENDOCEUTICS shall promptly notify AMAG in writing of the circumstances involved in such actual or anticipated Supply Failure, delay or shortfall, which notice shall include: (a) the underlying reasons for such anticipated interruption or failure to the extent known, any proposed remedial measures and, to the extent it can be reasonably determined, the date such interruption or failure is expected to end; and (b) any facts or circumstances that ENDOCEUTICS reasonably expects to affect its ability to Manufacture and supply PRODUCT in accordance with the terms of this Agreement. Such matter shall be discussed in good faith by the JSC. In the event of receipt of a Cessation Notice or the occurrence of a Supply Failure that is caused by an Uncontrollable Failure (as defined below), the Parties will work together to remedy those failures that are capable of remedy as appropriate through the application of commercially reasonable efforts or to identify a new manufacturer to remedy such failure, which manufacturer ENDOCEUTICS shall use commercially reasonable efforts to validate and appoint in accordance with Section 2.4, which manufacturer ENDOCEUTICS will control. For purposes of this Agreement, an “Uncontrollable Failure” means [***]. In the event of receipt of a Cessation Notice or the occurrence of a Supply Failure that is not caused by an Uncontrollable Failure, AMAG may elect, by written notice to ENDOCEUTICS given within [***] of AMAG’s receipt of the Cessation Notice or date of the Supply Failure (the “Election No...
