Common use of Updating and Amending Development Plan and Development Budget; Additional Development Activities Clause in Contracts

Updating and Amending Development Plan and Development Budget; Additional Development Activities. (a) On or before September 30th of each year during the Term, the JSC shall review, update and approve the Development Plan (including the Development Budget contained therein) which shall cover the Development Activities to be conducted during the upcoming calendar year, and the JSC shall, on at least a quarterly basis, review and update, as appropriate, the then-current Development Plan (including the Development Budget) to reflect any changes, reprioritizations of, or additions to the Development Plan; provided, however, that any disputes with respect thereto shall be resolved pursuant to Section 3.4. (b) From time to time during the Term, either Party may submit to the JSC any proposed expansion or other amendment of the Development Plan to cover additional Development Activities (or otherwise amend the Development Activities) with respect to the Product for use in the Field in the Territory for the JSC’s review and approval; provided, however, that any disputes with respect thereto shall be resolved pursuant to Section 3.4. Once approved by the JSC (or otherwise resolved pursuant to Section 3.4), each amended Development Plan (including the Development Budget contained therein) shall become effective and supersede the previous Development Plan and Development Budget as of the date of such approval or at such other time as decided by the JSC. (c) The Development Plan shall provide for, and Auxilium shall conduct under its General Development Activities, the Phase III Clinical program for Peyronie’s Disease for which the Parties have sought CHMP advice in the EU and FDA advice in the U.S. and that takes into account such guidance.