Common use of Development Plan and Budget Clause in Contracts

Development Plan and Budget. If either Party (or its licensees or Sublicensees) wishes to Conduct one or more Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product in a Licensed Indication in the Licensee Territory and the United States or related Party Development Activities (other than the Initial Development Activities, or, in the case of a Collaboration Compound, other than the Development activities under the applicable Collaboration Candidate Development Plan and Budget), then such Party, through its representatives on the JDC, shall provide the other Party with a written summary of such proposed Clinical Study and related Party Development Activities and any Information with respect thereto. Each Party shall only propose such Clinical Studies that it believes in good faith are scientifically reasonable. If both Parties are interested in conducting such Clinical Studies and related Party Development Activities, then the Parties, through their representatives on the JDC, shall use good faith efforts to agree on a Development Plan and Budget with respect thereto, which plan shall assign responsibility for such Clinical Studies and related Party Development Activities between the Parties (such activities, “Joint Development Activities”). It is contemplated that all Joint Development Activities shall be structured so as to support the filing of Drug Approval Applications for the Licensed Product both in the Major Markets and the United States. The Parties shall Conduct Joint Development Activities in accordance with the terms and conditions of this Agreement and the applicable Development Plan and Budget. If only one Party is interested in Conducting specific Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product in the Licensee Territory or the United States or related Party Development Activities, or the Parties are not able to agree on a Development Plan and Budget with respect thereto, then the interested Party, or in the absence of agreement each Party, shall have the right to Conduct such Clinical Studies or related Party Development Activities as Unilateral Activities as and to the extent provided in Section 3.7.1.

Development Plan and Budget. If either Party (or its licensees or Sublicensees) wishes to Conduct one or more Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product in a Licensed Indication in the Licensee Territory and the United States or related Party Development Activities (other than the Initial Development Activities, or, in the case of a Collaboration Compound, other than the Development activities under the applicable Collaboration Candidate Development Plan and Budget), then such Party, through its representatives on the JDC, shall provide the other Party with a written summary of such proposed Clinical Study and related Party Development Activities and any Information with respect thereto. Each Party shall only propose such Clinical Studies that it believes in good faith are scientifically reasonable. If both Parties are interested in conducting such Clinical Studies and related Party Development Activities, then the Parties, through their representatives on the JDC, shall use good faith efforts to agree on a Development Plan and Budget with respect thereto, which plan shall assign responsibility for such Clinical Studies and related Party Development Activities between the Parties (such activities, ““ Joint Development ActivitiesActivities ”). It is contemplated that all Joint Development Activities shall be structured so as to support the filing of Drug Approval Applications for the Licensed Product both in the Major Markets and the United States. The Parties shall Conduct Joint Development Activities in accordance with the terms and conditions of this Agreement and the applicable Development Plan and Budget. If only one Party Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. is interested in Conducting specific Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product in the Licensee Territory or the United States or related Party Development Activities, or the Parties are not able to agree on a Development Plan and Budget with respect thereto, then the interested Party, or in the absence of agreement each Party, shall have the right to Conduct such Clinical Studies or related Party Development Activities as Unilateral Activities as and to the extent provided in Section 3.7.1.