Development Plan: New Activities Sample Clauses

Development Plan: New Activities. (i) During the Term, either Party can propose that additional Development activities that are outside the scope of the Development Plan and not covered by the provisions of clause (c)(i) above, including any new Trials for new indications, be conducted under the Development Plan and the Development Budget. If such Party and the other Party agree in writing upon such additional Development activities, the Development Plan and the Development Budget shall be amended in writing by the Parties to reflect such agreement of the Parties, and all additional costs and expenses associated with such Development activities shall, unless the Parties otherwise agree, ***. (ii) In the event that the Parties do not reach agreement with any such additional Development activities described in clause (i) above, *** shall have the right, in its sole discretion, to complete the activities at its own cost and expense, provided any such new activities shall not interfere with the ability of the Parties ability to timely achieve the Primary Regulatory Approval Goals.