Study Plans Clause Samples

Study Plans. The Sponsor shall not make any use of this Contract, or any parts of the Study Plan prepared or supplied by Histologix or any related documents for any purpose other than, in advance of subscribing to the terms herein, deciding whether to enter into a business relationship with Histologix or, after subscribing to the terms herein, determining and enforcing or executing its rights and obligations conferred herein without the prior written approval of Histologix. The Sponsor shall not be entitled to assign or sub-Contract this Contract in whole or in part without the written consent of Histologix, which shall not be unreasonably withheld.

Study Plans. The Study Plans shall set forth in a level of detail consistent with industry practice the development activities and timelines for those activities to be performed as further set out below, including developing data and a common technical dossier as may be required by any applicable Regulatory Authority to obtain and maintain Marketing Approvals for the Product for the Field in the Territory. The Study Plans shall contain the following information: 4.5.1 the applicable design and scope for each Study Plan; 4.5.2 the budget for each Study Plan; 4.5.3 regulatory matters including Regulatory Materials to be filed with Regulatory Authorities, including estimated timing of meetings with Regulatory Authorities in support of activities described in this Article 4; 4.5.4 completion of the evidence generation for both the assessment and training elements of the RAG Offering; 4.5.5 a process through which the Parties may obtain input from Regulatory Authorities with respect to the design and success criteria of any clinical trials, including participation in the FDA’s Q-Submission Program; 4.5.6 a mechanism designed to address concerns that either Party may have regarding (a) market confusion with respect to any Product and any New Use Product or (b) coordination of activities related to the Product inside and outside the Territory; 4.5.7 scope and timelines for the conduct of all trials (including non-clinical, if any, and clinical (including any post-marketing clinical and safety activities)) designed to support marketing approval for the Product for the Field in the Territory; and 4.5.8 target schedules for achieving milestones so that the Pilot Study and Pivotal Study and any related submissions to Regulatory Authorities (collectively, the “Initial Studies”) will be complete and submitted within [***] ([***]) months of the Effective Date, and any period of extension pursuant to Section 4.6 or Section 4.9 (the “Initial Study Period”).