Common use of Data Monitoring Committee Clause in Contracts

Data Monitoring Committee. (a) Unless otherwise agreed by the CSOG, clinical trials related to Clinical Studies will be overseen and the results reviewed by an independent Data Monitoring Committee (“DMC”) established and supported by Sponsor. The CSOG will review and approve the DMC’s membership and procedures. Sponsor will assume responsibility for setting up and supporting all DMC meetings. The CSOG will be notified of any DMC meetings. A representative from each party will be invited to attend all open sessions of the DMC meetings. All DMC open sessions reports related to a Clinical Study will be made available to the CSOG. (b) The CSOG will decide whether to accept or reject a major DMC recommendation for a clinical trial conducted at MSKCC under the Joint Clinical Development such as a recommendation to close a clinical trial related to a Clinical Study. Should the CSOG unanimously agree on accepting a major DMC recommendation, the CSOG will communicate that decision to the members of the DMC. Should the CSOG not unanimously agree on accepting or rejecting a major DMC recommendation, the dispute resolution process described in Section 2.4 will be followed. In the rare case when the CSOG does not elect to accept for implementation a major DMC recommendation, the CSOG will communicate that decision to the members of the DMC with an appropriate and clear rationale. For the avoidance of doubt, the DMC operates independent of this Agreement, and MSKCC has no obligation to continue any Clinical Study contrary to the recommendation of the DMC.

Data Monitoring Committee. (a) Unless otherwise agreed by the CSOG, clinical trials related to Clinical Studies will be overseen and the results reviewed by an independent Data Monitoring Committee (“DMC”) established and supported by Sponsor. The CSOG will review and approve the DMC’s membership and procedures. Sponsor will assume responsibility for setting up and supporting all DMC meetings. The CSOG will be notified of any DMC meetings. A representative from each party will be invited to attend all open sessions of the DMC meetings. All DMC open sessions reports related to a Clinical Study will be made available to the CSOG. (b) The CSOG will decide whether to accept or reject a major DMC recommendation for a clinical trial conducted at MSKCC under the Joint Clinical Development such as a recommendation to close a clinical trial related to a Clinical Study. Should the CSOG unanimously agree on accepting a major DMC recommendation, the CSOG will communicate that decision to the members of the DMC. Should the CSOG not unanimously agree on accepting or rejecting a major DMC recommendation, the dispute resolution process described in Section 2.4 will be followed. In the rare case when the CSOG does not elect to accept for implementation a major DMC recommendation, the CSOG will communicate that decision to the members of the DMC with an appropriate and clear rationale. For the avoidance of doubt, the DMC operates independent of this Agreement, and MSKCC has no obligation to continue any Clinical Study contrary to the recommendation of the DMC. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.