CVOT definition
Examples of CVOT in a sentence
The Strategic Plan will cover both the long-term global strategy for each Product and, on a rolling [***]-month basis, the more detailed activities Novartis will perform over the course of the next [***] months, including overview and timing of the CVOT Novartis will conduct for the CVRR Indication Novartis will pursue for each Product.
Novartis will deliver an initial draft Strategic Plan for each Product to Akcea within [***] ([***]) calendar days after the date Novartis licenses a Product under Section 5.1. [***] It is agreed that the Initial Strategic Plan will primarily cover details pertaining to the CVOT Novartis will conduct for such Product.
The Parties’ goal is to mutually agree on changes to the Strategic Plan materially changing the CVRR Indication, the details or timing of the CVOT for a Product (each, a “Material Change”).
Prior to, but no later than [***] months before the anticipated Completion of the Phase 2 Dose-Ranging Trial for a Product, in preparation for the End of Phase 2b Meeting, Novartis will deliver to Akcea drafts of all documents Novartis reasonably determines are necessary for the End of Phase 2b Meeting, including, at a minimum, a draft [***] for the CVOT and the Cardiovascular Risk Reduction (or “CVRR”) Indication Novartis will pursue for such Product, draft [***] and [***].
The Parties will mutually agree on a plan and strategy (including key messages) for the conduct of the End of Phase 2b Meeting that reflects Akcea’s role as IND-holder for such Product and facilitates Novartis’ active participation as the Party potentially responsible for conducting the CVOT and IND and MAA/NDA-Holder in the event of Option exercise.
Prior to the Option Exercise, Novartis shall use Commercially Reasonable Efforts to conduct at risk the Pre-Option Novartis Activities attached hereto as SCHEDULE 1.3.2 so as to enable timely initiation of the CVOT for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx upon exercise by Novartis of the Option for such Product.
Takeda agrees to consider in good faith amendments to the current design of the CVOT PMR Study proposed by Orexigen to the extent Takeda deems such proposed amendments as necessary to maintain Orexigen’s regulatory approval in the EU; provided, however, that any such amendment to the current design of the CVOT PMR Study is subject to approval by the FDA, and any incremental Development Costs related to any such amendment shall be borne solely by Orexigen to the extent provided in Section 2.2.2(b)(iii).
For the avoidance of doubt, Takeda has final decision-making authority pursuant to Section 5.7.3(a)(i) with respect to a Dispute regarding Development Post-Approval Activities, including with respect to the design of the CVOT PMR Study.
The Parties acknowledge and agree that as of the Amended and Restated Effective Date, the current design of the CVOT PMR Study satisfies FDA and, to the Parties’ knowledge, EMA requirements for, and to support and maintain, Regulatory Approval in the Territory and regulatory approval in the EU.
Notwithstanding the foregoing, […***…] agrees to provide […***…] with the Data Monitoring Committee […***…] to […***…], the final Data Monitoring Committee charter and performance metrics as set forth in the performance standards document for the CVOT PMR Study, as such document may be revised from time to time, promptly after it is available to Takeda.