JSC Responsibilities and Decision-Making. 5.2.1 Responsibilities (Review and Discuss). The JSC’s responsibilities will include reviewing and discussing (but not approving) the following: 5.2.1.1 Oversight of the Parties’ collaboration for PNH including (i) overall strategic direction, (ii) developing strategies to maximize the value of the Product for the treatment of PNH, and (iii) reviewing and commenting on the Development Program and Regulatory Approval strategies; 5.2.1.2 material changes in the Development Program, including changes required by, or made to respond to comments from, a Regulatory Authority, that do not require approval pursuant to Section 5.2.2; 5.2.1.3 the activities related to, the progress of, and the costs incurred in connection with, the Development Program; 5.2.1.4 summaries of the Research Results; 5.2.1.5 Apellis’ forecast of the estimated timeline (on at least a [**] basis) for its development activities with respect to the Product for PNH; 5.2.1.6 the addition to the Development Program of any new clinical trial testing the efficacy of the Product for PNH; and 5.2.1.7 any other matters the Parties mutually agree will be, or are expressly provided in this Agreement to be, reviewed and discussed by the JSC.
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Sources: Development Funding Agreement (Apellis Pharmaceuticals, Inc.)
JSC Responsibilities and Decision-Making. 5.2.1 Responsibilities (Review and Discuss). The JSC’s responsibilities will include reviewing and discussing (but not approving) the following:
5.2.1.1 Oversight of the Parties’ collaboration for PNH including (ia) overall strategic direction, (iib) developing strategies to maximize the value of the Product for the treatment of PNHIndication, and (iiic) reviewing and commenting on the Development Program and Regulatory Approval strategies;
5.2.1.2 material changes in the Development Program, including changes required by, or made to respond to comments from, a Regulatory Authority, that do not require approval pursuant to Section 5.2.2;
5.2.1.3 the activities related to, the progress of, and the costs incurred in connection with, the Development Program;
5.2.1.4 summaries of the Research Results;
5.2.1.5 Apellis’ forecast of the estimated timeline (on at least a [**] quarterly basis) for its development activities with respect to the Product for PNHany of the Indications;
5.2.1.6 the addition to the Development Program of any new clinical trial HNC Clinical Trials testing the efficacy of the Product for PNHthe HNC Indication; and
5.2.1.7 any other matters the Parties mutually agree in writing will be, or are expressly provided in this Agreement to be, reviewed and discussed by the JSC.
Appears in 1 contract
JSC Responsibilities and Decision-Making. 5.2.1 Responsibilities (Review and Discuss). The JSC’s responsibilities will include reviewing and discussing (but not approving) the following:
5.2.1.1 Oversight of the Parties’ collaboration for PNH including (i) overall strategic direction, (ii) developing strategies to maximize the value of the Product for the treatment of PNHIndication, and (iii) reviewing and commenting on the Development Program and Regulatory Approval strategies;
5.2.1.2 material changes in the Development Program, including changes required by, or made to respond to comments from, a Regulatory Authority, that do not require approval pursuant to Section 5.2.25.2.2.2;
5.2.1.3 the activities related to, the progress of, and the costs incurred in connection with, the Development Program;
5.2.1.4 summaries of the Research Results;
5.2.1.5 Apellis’ forecast of the estimated timeline (on at least a [***] basis) for its development activities with respect to the Product for PNHthe Indication;
5.2.1.6 the addition to the Development Program of any new clinical trial Clinical Trials testing the efficacy of the Product for PNHthe Indication; and
5.2.1.7 any other matters the Parties mutually agree in writing will be, or are expressly provided in this Agreement to be, reviewed and discussed by the JSC.
Appears in 1 contract
Sources: Co Development Agreement (PhaseBio Pharmaceuticals Inc)