Common use of Development Plan and Development Budget Clause in Contracts

Development Plan and Development Budget. (a) The Development of each Collaboration Product in the Co-Promotion Territory for each Development Indication and Additional Indication, if any, shall be governed by a development plan ("Development Plan") and development budget ("Development Budget"), which shall provide for Development of Collaboration Products for Development Indications and Additional Indications, if any, in the Co-Promotion Territory and, together with updates, shall (except as provided in Section 5.04) be prepared by CTI after discussion and consultation with ORTHO and the JCC, for Development Budget approval by the Steering Committee. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) (b) The Parties have agreed upon and approved the Initial Development Plan and Budget. After the completion of the Phase II AML Trial, CTI shall provide ORTHO with all of the raw data related to the Phase II AML Trial and a draft clinical trial report (which shall be compiled from a secured and audited database and shall include patient listing statistics, methods and procedures) prepared by CTI with respect to the Phase II AML Trial (such data and report being collectively referred to herein as the "AML Trial Information"). The AML Trial Information shall be accompanied by a draft revised Development Plan and Development Budget for the AML Indication. ORTHO shall have the right, exercisable upon delivery of written notice to CTI not later than sixty (60) days following the date that the AML Trial Information is presented to ORTHO, to continue Development of Collaboration Products for an AML Indication hereunder for the period after June 30, 1997. In the event that ORTHO makes such election, it shall pay to CTI an amount equal to sixty percent (60%) of all expenses that were incurred by CTI in connection with the Development of Collaboration Products for an AML Indication on or after the Effective Date to the date of determination, other than any such amounts that were included in the Initial Development Plan and Budget and previously paid on a 60% basis by ORTHO, plus interest on such amount at an annual rate equal to *****. If ORTHO elects to exercise its option pursuant to this Section 4.05(b) to continue Development of Collaboration Products for an AML Indication, then ORTHO shall make the AML Milestone Payments to CTI pursuant to Section 3.02(b) hereof as provided therein. If any of the milestones set forth in Section 3.02(b) shall have been achieved prior to the date that ORTHO shall have exercised its option pursuant to Section 4.05(b) to continue Development of Collaboration Products for an AML Indication hereunder, then ORTHO shall make the AML Milestone Payments which correspond to such achieved milestones concurrently with the exercise of such option. (c) With respect to Collaboration Products for Additional Indications, the initial Development Plan and initial Development Budget for each such Additional Indication shall be agreed between the Parties pursuant to Section 5.04, and each subsequent Development Plan and Development Budget for each such Additional Indication shall be proposed by the JDC and submitted to the Steering Committee for review and Development Budget approval. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) (d) Each Development Plan shall describe the proposed overall program of Development for the subject Collaboration Product for the particular Development Indication or Additional Indication, as the case may be, in the Co- Promotion Territory, including preclinical studies, toxicology, formulation, process development, clinical studies and regulatory plans and other elements of obtaining Regulatory Approval in the Co-Promotion Territory, and shall include projected timelines for obtaining such Regulatory Approval. The Development Plan shall include a summary of estimated Development Expenses of the program expected during the Development process through obtaining Regulatory Approval in the Co-Promotion Territory for each proposed indication and route of delivery, and shall also include a detailed Development Budget for all Development activities proposed for the following ***** months. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) (e) Each Development Plan and Development Budget shall be updated annually by CTI after discussion and consultation with ORTHO and the JCC, and submitted by ***** of each calendar year to the Steering Committee for review and Development Budget approval. Each updated Development Budget shall be based on the corresponding updated Development Plan and shall be prepared in accordance with generally accepted accounting principles. The rate of any cost increases shall be reasonable and customary as measured by an agreed-upon index such as the All Urban Consumer Price Index. The Steering Committee shall provide comments on each such updated Development Plan and Development Budget within thirty (30) days following its submission to them and within ninety (90) days following such original submission the Steering Committee shall either approve the Development Budget submitted by the JDC or approve a modified Development Budget prepared by the Steering Committee consistent with the objectives for the Collaboration Products and the aims of the collaboration. If the Steering Committee fails to approve any change in the Development Budget or a material change in the Development Plan of the type described in Section 4.02(b)(ii), the Development Budget and Development Plan shall remain at its previously approved level or previous unmodified form.

Development Plan and Development Budget. (a) The All Development of each Collaboration Product Licensed Compounds and Licensed Products in the Co-Promotion Territory for each Development Indication and Additional Indication, if any, Hematology/Oncology Field shall be governed by a development clinical Development plan ("Development Plan") and development budget ("Development Budget"), which shall provide for Development of Collaboration Products for Development Indications and Additional Indications, if any, in the Co-Promotion Territory and, together with updates, shall (except as provided in Section 5.04) be prepared by CTI after discussion and consultation with ORTHO and the JCC, for Development Budget approval by the Steering Committee. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) (b) The Parties have agreed upon and approved the Initial Development Plan and Budget. After the completion of the Phase II AML Trial, CTI shall provide ORTHO with all of the raw data related to the Phase II AML Trial and a draft clinical trial report (which shall be compiled from a secured and audited database and shall include patient listing statistics, methods and procedures) prepared by CTI with respect to the Phase II AML Trial (such data and report being collectively referred to herein as the "AML Trial Information"). The AML Trial Information shall be accompanied by a draft revised Development Plan and Development Budget for the AML Indication. ORTHO shall have the right, exercisable upon delivery of written notice to CTI not later than sixty (60) days following the date that the AML Trial Information is presented to ORTHO, to continue Development of Collaboration Products for an AML Indication hereunder for the period after June 30, 1997. In the event that ORTHO makes such election, it shall pay to CTI an amount equal to sixty percent (60%) of all expenses that were incurred by CTI in connection with the Development of Collaboration Products for an AML Indication on or after the Effective Date to the date of determination, other than any such amounts that were included in the Initial Development Plan and Budget and previously paid on a 60% basis by ORTHO, plus interest on such amount at an annual rate equal to *****. If ORTHO elects to exercise its option pursuant to this Section 4.05(b) to continue Development of Collaboration Products for an AML Indication, then ORTHO shall make the AML Milestone Payments to CTI pursuant to Section 3.02(b) hereof as provided therein. If any of the milestones set forth in Section 3.02(b) shall have been achieved prior to the date that ORTHO shall have exercised its option pursuant to Section 4.05(b) to continue Development of Collaboration Products for an AML Indication hereunder, then ORTHO shall make the AML Milestone Payments which correspond to such achieved milestones concurrently with the exercise of such option. (c) With respect to Collaboration Products for Additional Indications, the initial Development Plan and initial Development Budget for each such Additional Indication shall be agreed between the Parties pursuant to Section 5.04, and each subsequent Development Plan and Development Budget for each such Additional Indication shall be proposed by the JDC and submitted to the Steering Committee for review and Development Budget approval. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) (d) Each Development Plan shall describe describes the proposed overall program of Development for the subject Collaboration Product for the particular Development Indication or Additional Indication, as the case may be, in the Co- Promotion Territory, including preclinical studies, toxicology, formulation, process development, clinical studies Licensed Compounds and regulatory plans and other elements of obtaining Licensed Products through Regulatory Approval in the Co-Promotion Hematology/Oncology Field in the Territory, and shall include projected timelines along with the strategy for obtaining such seeking Regulatory ApprovalApproval of Licensed Products (the “Development Plan”). The Development Plan shall include have an associated annual budget (“Development Budget”), as well as a summary preliminary estimate of estimated Development Expenses of Costs for the program expected during two (2) years immediately following the twelve (12) month period included in such annual Development Budget which is provided for informational purposes only. For clarity, the Parties acknowledge that the Development process through obtaining Regulatory Approval in the Co-Promotion Territory for each proposed indication and route of delivery, and shall also include a detailed Development Budget for all Development activities proposed Budgets for the following ***** months. years may not resemble or reflect the preliminary estimate of Development Costs provided for the two (The information below marked by ***** has been omitted by a request for confidential treatment2) years immediately following the twelve (12) month period included in such annual Development Budget. The omitted portion has been separately filed with the Commission.) (e) Each initial Development Plan is attached hereto as Exhibit 5.1(b) (and same may be amended from time to time during the Term by the JDC). The initial Development Budget shall be updated annually by CTI after discussion and consultation with ORTHO exchanged between the Parties via email prior to the Execution Date and the JCC, and submitted by ***** of each calendar year to the Steering Committee for review and Development Budget approval. Each updated Development Budget shall be based on the corresponding updated initial Development Plan agreed to by the Parties as of the Execution Date were preliminary in nature and shall be prepared in accordance with generally accepted accounting principles. The rate of any cost increases shall be reasonable and customary as measured finalized by an agreed-upon index such as the All Urban Consumer Price Index. The Steering Committee shall provide comments on each such updated Development Plan and Development Budget JDC within thirty (30) days following its submission to them after the Effective Date. The Development Plan and within ninety (90) days following such original submission the Steering Committee shall either approve the Development Budget submitted will be updated on at least an annual basis. Subject to review, comment and approval (as applicable) by the JDC or approve a modified Development Budget prepared by the Steering Committee consistent with the objectives for the Collaboration Products and the aims JSC, in accordance, in each case of the collaboration. If following subsections (i) and (ii), with ARTICLE III, Incyte shall have (i) the Steering Committee fails to approve any change in the Development Budget or a material change in sole right and responsibility for preparing the Development Plan of the type described in Section 4.02(b)(ii), the and Development Budget and amendments thereto for submission to the JDC and (ii) final decision-making authority over all decisions with respect to the Development Plan shall remain at its previously approved level or previous unmodified formPlan, Development Budget and all research and Development activities with respect to Licensed Compounds and Licensed Products in the Territory.