Additional Phase III Studies Sample Clauses

Additional Phase III Studies. Notwithstanding anything in this Agreement (including Section 5.6(d)(v)) to the contrary, if, after the completion of all Phase III Clinical Studies and other Development activities set forth in a then-current Joint Phase III Plan, any Regulatory Authority recommends or requires that an additional Phase III Clinical Study(ies) (or other additional Development activity(ies)) be conducted in order to obtain and prior to obtaining, Regulatory Approval for a Joint Product in an Indication in the applicable Profit Share Region, either Party may propose to the applicable JDC an amendment to such Joint Phase III Plan to add such additional Phase III Clinical Study(ies) (or other additional Development activity(ies)). If such JDC cannot agree on any such proposed amendment within a [***]-day period, then such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within a [***]-day period, then such matter shall be referred to the Parties’ Senior Officers for resolution. If such Senior Officers cannot resolve such matter within a [***]-day period [***]. Any Product containing such Product Candidate shall thereafter be deemed a Unilateral Product (with the Party continuing with such Development as the Participating Party) and the other Party shall be entitled to receive royalties on such Unilateral Product pursuant to Section 11.4(a)(i).