Common use of Development Plan: Additional Activities Within Development Plan Clause in Contracts

Development Plan: Additional Activities Within Development Plan. (i) During the Term, if (x) either Party reasonably concludes that additional Development activities are reasonably necessary in connection with the implementation of the Development Plan, and such activities are within the scope of the Development Plan, or (y) the costs and expenses set forth in the Development Budget are insufficient to allow for a proper implementation of the activities and goals set forth in the Development Plan, the Parties shall negotiate in good faith to reach resolution regarding appropriate amendments to the Development Plan and the Development Budget which will address such additional Development activities or Development Budget shortfall, as the case may be. If the Parties are able to reach written agreement on such amendments to the Development Plan and the Development Budget, all additional costs in respect thereof shall be ***. In the event that the Parties cannot agree on appropriate amendments to the Development Plan and the Development Budget, within *** days following such time as the Parties began such negotiations (or were obligated to enter into such negotiations), either Party shall have the right to submit the matter for resolution in accordance with the arbitration procedure set forth in Section 3.1.3(e) below. Following resolution of any matter so submitted for resolution in accordance with such arbitration procedures, (x) those amendments and supplements to the Development Plan and the Development Budget that were submitted to the Expert Arbitrator by the Prevailing Party *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. shall automatically be deemed to amend and supplement the Development Plan and the Development Budget, and (y) all additional costs and expenses associated with the Development activities contemplated by such amendments and supplements *** by the Parties. (ii) In addition, *** shall have the right, in its sole discretion, to submit additional amendments and supplements to the Development Plan and the Development Budget which reflect any proposed amendments or supplements that were made by either Party pursuant to clause (i) above, which additional amendments and supplements shall automatically be deemed to amend and supplement the Development Plan and the Development Budget; provided, that (i) any additional costs and expenses associated with such Development activities shall be borne by *** and (ii) *** shall use Commercially Reasonable Efforts to ensure that the additional activities related to such amendments and supplements do not unnecessarily extend the timeline or cost required to achieve the Primary Regulatory Approval Goals.