General; ROW Development Plan Sample Clauses

General; ROW Development Plan. Takeda shall conduct the Development of the Product for the ROW Territory, in collaboration and consultation with Cell Genesys through the JDC subject to the terms and conditions of this Agreement, and pursuant to a written development plan (the “ROW Development Plan”). The ROW Development Plan will be summary in nature, but will include all Development and Manufacturing activities anticipated to be required for obtaining Regulatory Approval in the ROW Territory and timelines regarding such activities. The ROW Development Plan shall also specify the plans and timeline for preparing the necessary Regulatory Materials and for obtaining Regulatory Approval in the ROW Territory for the first indication and any label expansion. On at least an annual basis (no later than December 1 of each calendar year, commencing in 2008), Takeda shall update and amend, as appropriate, the then-current ROW Development Plan and shall submit such updates and/or amendments for review and comment by the JDC. Takeda shall review and consider all comments to the ROW Development Plan from the JDC or JSC in good faith. The ROW Development Plan shall not require the approval of the JDC or the JSC, but this shall not excuse Takeda from otherwise meeting its obligations with respect to the Development of the Product in the ROW Territory as provided in this Agreement. Except for the VITAL Studies conducted by Cell Genesys or as Cell Genesys may agree at the JSC, Takeda will be responsible, at its expense for conducting all studies necessary or desirable for any Regulatory Approvals in the ROW Territory pursuant to the ROW Development Plan.