Common use of Development Plan and Development Budget Clause in Contracts

Development Plan and Development Budget. (a) The Development of the Product shall be governed by a global Development plan (“Development Plan”), and the costs and expenses relating to the Development of the Product shall be governed by a Development budget (“Development Budget”), the initial forms of which are attached as Exhibits 4.2(a)(i) and 4.2(a)(ii), respectively. Updates thereto made pursuant to Section 4.2(b) shall be prepared by the GPT, for approval by the JSC. Each Development Plan shall include without limitation details of all Clinical Trials to be conducted by the Parties to support Regulatory Approval in the Territory, and related time lines, as well as other material activities necessary for Development of the Product in the Territory, and shall describe the proposed overall program of Development for the Product in each applicable country, including without limitation all preclinical studies, toxicology, pharmacology studies, formulation, process development, clinical studies, and regulatory plans and other elements of obtaining Regulatory Approval in each applicable country. The Development Plan and the Development Budget shall be updated at least once (1) per year and shall cover the following three (3) year period. The Parties have prepared a portion of the initial Development Plan specifically relating to the Device and a portion of the initial Development Budget relating to the Device (“Device Budget”) as well as a portion of the initial Development Plan specifically relating to Formulated Amikacin and a portion of the initial Development Budget relating to Formulated Amikacin (“Drug Budget”), respectively, as of the Effective Date, which initial budgets are attached as Exhibits 4.2(a)(iii) and 4.2(a)(iv), respectively. (b) The GPT shall, on an annual basis, propose updates to the Development Plans and Development Budgets (including, for clarity, the Device Budget and the Drug Budget) for the following calendar year. The GPT shall submit such updated Development Plans and Development Budgets to the JSC (with such Development Budgets first being submitted to the JFC for review and endorsement), for review and approval by September 30 of each calendar year for the following calendar year. The JSC shall provide comments on each such updated Development Plan or Development Budget, as applicable, within fifteen (15) days following their submission. Within thirty (30) days following such original submission, the JSC shall either approve the Development Plan and Development Budget or approve a modified Development Plan and Development Budget prepared by the GPT and endorsed by the JFC, consistent with the objectives for the Product and the aims of the Project. (c) If the actual costs incurred by Bayer under the Drug Budget in meeting Bayer’s obligations as set forth on Exhibit 4.2(a)(iv) exceed the approved amount set forth in the Drug Budget, Bayer may spend such additional amounts without reimbursement from Nektar; provided that, if aggregate actual costs incurred by Bayer exceed [***] of the aggregate approved amount set forth in the Drug Budget, the Parties agree to discuss whether the economic terms between the Parties should be restructured to reflect the investment of the additional funds. If the actual costs incurred by Nektar under the Device Budget in meeting Nektar’s obligations as set forth on Exhibit 4.2(a)(iii) exceed the approved amount set forth in the Device Budget, Nektar may spend such additional amounts without reimbursement from Bayer; provided that, if aggregate actual costs incurred by Nektar exceed [***] of the aggregate approved amount set forth in the Device Budget, the Parties agree to discuss whether the economic terms between the Parties should be restructured to reflect the investment of the additional funds.

Development Plan and Development Budget. (a) The Development of each Collaboration Compound and/or Collaboration Product in the Product Profit/Loss Sharing Territory for each Development Indication and/or Additional Indication shall be governed by carried-out pursuant to a global Development development plan (“"Development Plan”)") and development budget ("Development Budget") that shall each cover the period through regulatory approvals to market for the Development Indication and/or Additional Indications, as applicable to such plan or budget. Each such Development Plan and Development Budget shall (except as provided in Article V) be prepared by the costs JPT. The Development Plan and expenses relating Development Budget for the Profit/Loss Sharing Territory shall be agreed to by the JPT and submitted for approval by the Steering Committee pursuant to Section 2.03. Any Development Plan and Development Budget as it relates to the Royalty Bearing Territory shall be submitted to the JPT and Steering Committee for the sole purpose of permitting Development Activities in the Royalty Bearing Territory to be coordinated with Development Activities in the Profit/Loss Sharing Territory. (b) ERGO shall provide ORTHO with access (and copies, which may be partially or wholly electronic form, to the extent requested) to all of the raw data and reports related to the Development of Bromocriptine for the Product Type II Diabetes Indication and the Obesity Indication (such data and report being collectively referred to herein as the "Bromocriptine Trial Information"). The Bromocriptine Trial Information shall be governed accompanied by a ERGO's most up-to-date Development budget Plan and Development Budget for the Type II Diabetes Indication and through the end of the Obesity Phase IIA Clinical Trial and will be referred to as the "Initial Development Plan and Development Budget for Bromocriptine for the Type II Diabetes Indication and the Obesity Indication," attached hereto as Exhibit E (“c) With respect to Development Budget”)of Eligible Compounds (including Eligible Compounds that are already Collaboration Compounds) for an indication that is not already an extant Development Indication or an extant Additional Indication and that is accepted for joint Development, an Initial Development Plan and Initial Development Budget for each such Indication shall be agreed between the initial forms of which are attached as Exhibits 4.2(a)(i) Parties pursuant to provisions set forth in Article V. Such Initial Development Plan and 4.2(a)(ii)Initial Development Budget shall cover the period through regulatory approvals to market such new Indications. Each subsequent, respectively. Updates thereto made updated Development Plan and each subsequent updated Development Budget shall be prepared and agreed upon by the JPT in coordination with the Lead Development Party and submitted to the Steering Committee for review and approval pursuant to Section 4.2(b2.03. (d) shall be prepared by the GPT, for approval by the JSC. Each Development Plan shall include without limitation details of all Clinical Trials to be conducted by the Parties to support Regulatory Approval in the Territory, and related time lines, as well as other material activities necessary for Development of the Product in the Territory, and shall describe the proposed overall program of Development for the subject Collaboration Compound and/or Collaboration Product for each particular Development Indication and/or Additional Indication, as the case may be, in each applicable countrythe Profit/Loss Sharing Territory, including without limitation all including, but not limited to, preclinical studies, toxicology, pharmacology studies, formulation, chemical process development, clinical studies, and regulatory plans and other elements of obtaining Regulatory Approval in each applicable countrythe Profit/Loss Sharing Territory. The Development Plan shall include projected timelines for all Development and Regulatory events, a summary of the estimated Development Expenses and specify Party-specific execution responsibilities of the program expected during Development through obtaining Regulatory Approval in the Profit/Loss Sharing Territory for each Collaboration Compound and/or Collaboration Product for each such proposed Indication, and shall further include a detailed Development Budget by quarter for all Development proposed for the following eighteen (18) months. (e) An updated Development Plan and an updated Development Budget shall be updated at least once (1) per year prepared annually by the JPT, and shall cover the following three (3) year period. The Parties have prepared a portion of the initial Development Plan specifically relating to the Device and a portion of the initial Development Budget relating to the Device (“Device Budget”) as well as a portion of the initial Development Plan specifically relating to Formulated Amikacin and a portion of the initial Development Budget relating to Formulated Amikacin (“Drug Budget”), respectively, as of the Effective Date, which initial budgets are attached as Exhibits 4.2(a)(iii) and 4.2(a)(iv), respectively. (b) The GPT shall, on an annual basis, propose updates to the Development Plans and Development Budgets (including, for clarity, the Device Budget and the Drug Budget) for the following calendar year. The GPT shall submit such updated Development Plans and Development Budgets to the JSC (with such Development Budgets first being submitted to the JFC for review and endorsement), for review and approval by September June 30 of each calendar year to the Steering Committee for review and approval. Each updated Development Budget for the following calendar year. The JSC Profit/Loss Sharing Territory shall provide comments be based on each such the corresponding updated Development Plan or Development Budget, as applicable, within fifteen (15) days following their submissionand shall be prepared in accordance with generally accepted accounting principles. Within thirty (30) days following such original submission, submission the JSC Steering Committee shall either approve the updated Development Plan and updated Development Budget or approve a modified Development Plan and Development Budget prepared by the GPT and endorsed by the JFC, Steering Committee consistent with the objectives for the Product Collaboration Compound and/or Collaboration Products and the aims of the Projectcollaboration. 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 last approved Development Budget and last approved Development Plan shall remain in effect, such that the Development Budget shall remain at previously approved levels of projected spending and the Development Plan shall remain in its previously approved form. (cf) If A Development Plan and Budget for the actual costs incurred Obesity Indication for Bromocriptine for Phase IIB and III Clinical Trials shall be agreed to by Bayer under the Drug Budget in meeting Bayer’s obligations as set forth Parties at about the time data from ERGO's Obesity Phase IIA Clinical Trial is available. Should the Parties fail to agree on Exhibit 4.2(a)(iv) exceed the approved amount set forth in the Drug Budget, Bayer may spend such additional amounts without reimbursement from Nektar; provided that, if aggregate actual costs incurred by Bayer exceed [***] of the aggregate approved amount set forth in the Drug Budgetplan and budget, the Parties joint Development for the Obesity Indication shall be suspended until such time as the parties mutually agree to discuss whether the economic terms between the Parties should be restructured to reflect the investment of the additional funds. If the actual costs incurred by Nektar under the Device Budget in meeting Nektar’s obligations as set forth on Exhibit 4.2(a)(iii) exceed the approved amount set forth in the Device Budget, Nektar may spend such additional amounts without reimbursement from Bayer; provided that, if aggregate actual costs incurred by Nektar exceed [***] of the aggregate approved amount set forth in the Device Budget, the Parties agree to discuss whether the economic terms between the Parties should be restructured to reflect the investment of the additional fundsa plan and budget therefor.

Development Plan and Development Budget. (a) The Development of the Product shall will be governed by a global Development plan (“Development Plan”), and the costs and expenses relating to the Development of the Product shall will be governed by a Development budget (“Development Budget”), the initial forms agreed versions of which are attached as Exhibits 4.2(a)(i) and 4.2(a)(ii), respectively. Updates thereto made pursuant to Section 4.2(b) shall will be prepared by the GPTJDC; provided, for approval that either Party may propose updates to the Development Plan to be made by the JSCJDC. Each Development Plan shall include without limitation details may include, as mutually agreed by the Parties: (1) a description of all Clinical Trials to be conducted by the Parties Fibrocell and, if applicable, CCP to support Regulatory Approval in the Territory, and related time lines, as well as timelines; (2) other material activities necessary for Development of the Product in the Territory, and shall describe ; (3) the proposed overall program of Development for the Product in each applicable countrythe Territory, including without limitation all preclinical studies, toxicology, pharmacology studies, formulation, process development, clinical studies, and regulatory plans Regulatory Plans and other elements of obtaining Regulatory Approval in the Territory; (4) at an appropriate stage of Development, a publication strategy; (5) the roles and responsibilities of each applicable countryParty and the JDC, and, if applicable, each subcommittee of the JDC; and (6) plans related to clinical Manufacturing of the Product and to Manufacturing scale-up to enable commercial scale manufacturing prior to Commercial Launch. The Development Plan and the Development Budget shall will be updated at least once (1per calendar year in accordance with Section 4.2(b) per year and shall will cover the following three (3) calendar year period. The Parties have prepared a portion of the initial Development Plan specifically relating to the Device and a portion of the initial Development Budget relating to the Device (“Device Budget”) as well as a portion of the initial Development Plan specifically relating to Formulated Amikacin and a portion of the initial Development Budget relating to Formulated Amikacin (“Drug Budget”), respectively, as of the Effective Date, which initial budgets are attached as Exhibits 4.2(a)(iii) and 4.2(a)(iv), respectively. (b) The GPT shallJDC will, on an annual basis, propose prepare and approve updates to the Development Plans Plan and Development Budgets (including, for clarity, the Device Budget and the Drug Budget) for the following calendar year. The GPT shall submit such updated Development Plans and Development Budgets to the JSC (with such Development Budgets first being submitted to the JFC for review and endorsement), for review and approval by September 30 of each calendar year for the following three (3) calendar yearyear period, which updates shall be subject to the unanimous consent of the JDC through Initial BLA Approval. The JSC shall provide comments on each From time to time in between such updated Development Plan or Development Budget, as applicable, within fifteen (15) days following their submission. Within thirty (30) days following such original submissionannual updates, the JSC shall either approve JDC may amend the Development Plan and Development Budget or approve a modified Development Plan and Development Budget prepared by the GPT and endorsed by the JFCPlan, consistent with the objectives for the Product and the aims of the Project.principles set forth in Section 4.1. 18 US-DOCS\106669270.9 (c) If The costs of the actual costs incurred by Bayer under the Drug Budget Development activities set out in meeting Bayer’s obligations each Development Plan as set forth on Exhibit 4.2(a)(iv) exceed the approved amount set forth in the Drug Budgetapplicable approved Development Budget will be allocated between the Parties as set out in Article 9, Bayer may spend provided that CCP will be solely responsible for the first twenty million Dollars ($20,000,000) of such additional amounts without reimbursement from Nektar; provided that, if aggregate actual costs incurred by Bayer exceed [***] costs. The Parties agree that the total amount of the aggregate approved amount Fibrocell costs set forth in the Drug Budget, initial Development Budget attached hereto as Exhibit 4.2(a)(ii) will be reimbursed to Fibrocell in accordance with Section 9.2 to the Parties agree to discuss whether the economic terms between the Parties should be restructured to reflect the investment of the additional funds. If the actual costs incurred by Nektar under the Device Budget in meeting Nektar’s obligations as set forth on Exhibit 4.2(a)(iii) exceed the approved amount set forth in the Device Budget, Nektar may spend extent that Fibrocell actually incurs such additional amounts without reimbursement from Bayer; provided that, if aggregate actual costs incurred by Nektar exceed [***] of the aggregate approved amount set forth in the Device Budget, the Parties agree to discuss whether the economic terms between the Parties should be restructured to reflect the investment of the additional fundscosts.