Cancer Development Plan Clause Samples

Cancer Development Plan. The Development of Cancer Product in the Cancer Field shall be conducted pursuant to a development plan (the “Cancer Development Plan”). The Cancer Development Plan, prepared as set forth below, shall provide an overview of key activities projected for the Development of the applicable Cancer Product in the Cancer Field from the then-current date through Regulatory Approval(s) of such Product in [***], including an outline of significant [***] and [***] in the Cancer Field in [***]. In the case of the Co-Developed Product, the Cancer Development Plan (i.e., the Joint Cancer Development Plan) will also specify for each activity in the Joint Cancer Development Plan the Party responsible for carrying out the activity (or that the Parties are jointly responsible) consistent with the principles set forth in Section 3.4 and the Development Costs the Parties expect to incur for each activity in the Joint Cancer Development Plan (which is referred to herein as the “Cancer Development Budget”). Accordingly, in the case of the Co-Developed Product, the Joint Cancer Development Plan will also include the Cancer Development Budget. In addition, the Joint Cancer Development Plan shall clearly indicate whether a Clinical Trial in the plan (i) is approved in accordance with Section 3.6 to be conducted without any contingencies or success criteria needing to be previously met (such approved Clinical Trial being an “Approved Study”), (ii) is approved to be conducted subject to certain contingencies or success criteria previously being met or (iii) is proposed or projected but not yet approved to be conducted. For clarity, a Clinical Trial for the Co-Developed Product which is not an Approved Study would not be undertaken, and the Cancer Development Costs would not include the costs for any Clinical Trial which is not an Approved Study, except in accordance with Section 3.6 or unless the Parties otherwise agree in writing. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.