Development Plans and Budgets. Promptly after the selection by the JRC of a SAC for development as a Collaboration Product by the Parties, the JDC shall prepare and provide to each Party for final approval a development plan for such SAC (the "Development Plan"). The Development Plan shall include all needed details regarding the Preclinical and Clinical Development, and other work to be undertaken to develop and produce the International Registration Dossier for such Collaboration Product, including an allocation of all such work as appropriate to each Party (or to selected Third Party contractors, as agreed), and shall establish a budget (the "Development Budget") for all costs and expenses to be incurred by each Party in conducting the work allocated to it under such Development Plan. The budget will be based on (i) an allocation of Full Time Equivalent (FTE) personnel of each Party working under the Development Plan, with each FTE costed at an annualized rate of U.S.$[...***...] (which rate will be increased on each anniversary of the Effective Date by [...***...]%); (ii) the actual extraordinary direct costs approved by the JDC, and (iii) the actual costs of work performed by Third Parties as approved by the JDC. Each Party shall diligently review the proposed Development Plan and shall either approve the plan or provide the JDC any requested changes and comments. If a Party provides such requested changes or comment to a proposed Development Plan, the JDC shall review the proposed changes within thirty (30) days, and as appropriate, thereafter prepare a revised draft of the Development Plan, accommodating such changes and comments, and resubmit such revised Development Plan for approval by the Parties as provided above. Once the Parties have agreed on the Development Plan proposed by the JDC, such Development Plan shall be effective and shall control and govern the Parties' development effort with respect to the applicable Product, subject to any subsequent amendments or modifications to such Development Plan as provided below. From time to time during the development of such Collaboration Product, the JDC shall review the Development Plan in light of the results of the development work and any other relevant Information and shall amend or modify the Development Plan as appropriate, provided that the JDC may not increase the applicable Development Budget without the written approval of each Party. At least sixty (60) days prior to January 1 of any year in which the Parties are developing a particular Collaboration Product hereunder, the JDC shall review the applicable Development Budget for such Collaboration Product and shall submit a revised and updated Development Budget for the coming calendar year to each of the Parties for approval as provided above. Upon such approval, the Development Budget shall be 10 ***CONFIDENTIAL TREATMENT REQUESTED effective for the development of such Collaboration Product during such calendar year, subject further to amendment of the applicable Development Plan.
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Sources: Collaboration Agreement (SGX Pharmaceuticals, Inc.), Collaboration Agreement (SGX Pharmaceuticals, Inc.)
Development Plans and Budgets. Promptly after the selection by the JRC of a SAC particular Product for development as a Collaboration Product by the Parties, the JDC shall prepare and provide to each Party for final approval a development plan for such SAC Product in the Joint Territory (the "Development Plan"). The Development Plan shall include all needed details regarding the Preclinical and Clinical Development, clinical development and other work to be undertaken to develop and produce such Product in the International Registration Dossier for such Collaboration ProductJoint Territory, including an allocation of all such work as appropriate to each Party (or to selected Third Party contractors, as agreed), and shall establish a budget (the "Development Budget") for all costs and expenses to be incurred by each Party in conducting the work allocated to it under such Development Plan. The budget will be based on (i) an allocation of Full Time Equivalent (FTE) personnel of each Party working under the Development Plan, with each FTE costed at an annualized rate of U.S.$[...***...] (which rate will be increased on each anniversary of the Effective Date by [...***...]%); (ii) the actual extraordinary direct costs approved by the JDC, and (iii) the actual costs of work performed by Third Parties as approved by the JDC. Each Party shall diligently review the proposed Development Plan and shall either approve the plan or provide the JDC any requested changes and comments. If a Party provides such requested changes or comment to a proposed Development Plan, the JDC shall review the proposed changes within thirty (30) days, and as appropriate, promptly thereafter prepare a revised draft of the Development Plan, accommodating such changes and comments, and resubmit such revised Development Plan for approval by the Parties as provided above. Once the Parties have agreed on the Development Plan proposed by the JDC, such Development Plan shall be effective and shall control and govern the Parties' development effort in the Joint Territory with respect to the applicable Product, subject to any subsequent amendments or modifications to such Development Plan as provided below. From time to time during the development of such Collaboration Product, the JDC shall review the Development Plan in light of the results of the development work and any other relevant Information and shall amend or modify the Development Plan as appropriate, provided that the JDC may not increase the applicable Development Budget without the written approval of each Party. At least sixty (60) days prior to January 1 of any year in which the Parties are developing a particular Collaboration Product hereunder, the JDC shall review the applicable Development Budget for such Collaboration Product Products and shall submit a revised and updated Development Budget for the coming calendar year to each of the Parties for approval as provided above. Upon such approval, the Development Budget shall be 10 ***CONFIDENTIAL TREATMENT REQUESTED effective for the development of such Collaboration Product in the Joint Territory during such calendar year, subject further to amendment of the applicable Development Plan.
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