Common use of Development Plans Clause in Contracts

Development Plans. As soon as practicable after formation of the JDC, the JDC shall prepare and approve the initial Development Plan for Development of the Licensed Product for the Initial Indication in the formulation existing as of the Effective Date in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Development Plan is consistent with the general Development Plan outline set forth in Exhibit B attached hereto and incorporated herein (the “General Development Plan Outline”). The JDC shall prepare and approve a separate Development Plan for Development of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Development of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Development Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments and revisions to the Development Plan shall be reviewed and discussed, in advance, by the JDC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Development Plan. Any amendment or revision to the Development Plan that provides for an increase or decrease in the number of FTEs as compared to the previous version of the Development Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Development Plan, or that moves forward the timetable for activities reflected in the Development Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Development activities to the amended or revised Development Plan. Each Development Plan shall identify the goals of the Development program contemplated thereunder and shall address Development activities related to the Licensed Compound or the Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including: (i) the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted, including the number of FTEs (subject to Section 4.2) and the applicable FTE Rate and out-of-pocket expenses to be incurred in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for Development activities in the Development Plan after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Development Plan; (ii) clinical trials (including Phase 4 Clinical Trials but excluding Phase 3b Clinical Trials or Post-Approval Studies) to generate data for use in seeking, obtaining or maintaining Regulatory Approval and for labeling of the Licensed Product for the Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; (iii) resources required to perform each required Development activity, including the scope of the work to be performed by internal resources of each of the Parties or by CROs or other permitted subcontractors, if applicable; (iv) milestones to be met, deliverables to be provided and the timeline for completion of each Development activity; (v) the members of the Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (vi) design and implementation of regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be supplied by Otsuka for use in clinical trials in the Territory.

Development Plans. As soon as practicable after formation of the JDC, the JDC shall prepare and approve the initial Development Plan for Development of the Licensed Product for the Initial Indication in the formulation existing as of the Effective Date in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Development Plan is consistent with the general Development Plan outline set forth in Exhibit B attached hereto and incorporated herein (the “General Development Plan Outline”). The JDC shall prepare and approve a separate Development Plan for Development of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Development of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Development Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments and revisions to the Development Plan shall be reviewed and discussed, in advance, by the JDC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Development Plan. Any amendment or revision to the Development Plan that provides for an increase or decrease in the number of FTEs as compared to the previous version of the Development Plan, or that provides for addition or discontinuation of tasks or activities as * Confidential Treatment Requested. compared to the previous version of the Development Plan, or that moves forward the timetable for activities reflected in the Development Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Development activities to the amended or revised Development Plan. Each Development Plan shall identify the goals of the Development program contemplated thereunder and shall address Development activities related to the Licensed Compound or the Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including: (i) the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted, including the number of FTEs (subject to Section 4.2) and the applicable FTE Rate and out-of-pocket expenses to be incurred in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for Development activities in the Development Plan after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Development Plan; (ii) clinical trials (including Phase 4 Clinical Trials but excluding Phase 3b Clinical Trials or Post-Approval Studies) to generate data for use in seeking, obtaining or maintaining Regulatory Approval and for labeling of the Licensed Product for the Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; (iii) resources required to perform each required Development activity, including the scope of the work to be performed by internal resources of each of the Parties or by CROs or other permitted subcontractors, if applicable; (iv) milestones to be met, deliverables to be provided and the timeline for completion of each Development activity; (v) the members of the Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (vi) design and implementation of regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be supplied by Otsuka for use in clinical trials in the Territory.

Development Plans. As soon as practicable after formation of the JDC, the JDC (a) Confidential Treatment Requested Licensee shall prepare and approve the initial Development Plan for Development of the Licensed Product for the Initial Indication in the formulation existing as of deliver to Xxxxxxx within [...***...] after the Effective Date in a written development plan for the Territory. The Parties shall use Commercially Reasonable Efforts AR Mutant Program describing the activities to ensure that be performed to up to and including the conduct and completion of the AR Mutant POC Trial and the AR Mutant Pre-Phase III Activities, the deliverables for such initial Development Plan is consistent with the general Development Plan outline set forth in Exhibit B attached hereto activities, target dates and incorporated herein estimated timelines for completion of such activities and a budget for such activities (the “General AR Mutant Development Plan OutlinePlan”). The JDC Development Plan for the AR Mutant Program shall at all times contain [...***...]. Xxxxxxx shall review the initial AR Mutant Development Plan within [...***...] following receipt thereof and may provide comments on such AR Mutant Development Plan, which Licensee shall consider in good faith. Any portion of the initial AR Mutant Development Plan describing a Xxxxxxx AR Mutant Activity that is not set forth on Schedule Xxxxxxx AR Mutant Activities, or setting forth a target date or timeline for any Xxxxxxx AR Mutant Activity, will not become effective unless and until approved in writing by Xxxxxxx. (b) Licensee shall prepare and approve deliver to Xxxxxxx within [...***...] after the Effective Date a separate written development plan for the NIK Program describing the activities to be performed to up to and including the conduct and completion of the NIK POC Trial, the deliverables for such activities, target dates and estimated timelines for completion of such activities and a budget for such activities (the “NIK Development Plan” and the AR Mutant Development Plan or the NIK Development Plan, a “Development Plan”). The Development Plan for Development of Licensed Product for the Initial Indication in NIK Program shall at all times contain: [...***...]. Xxxxxxx shall review the Initial Formulation in the Territory and for Development of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each initial NIK Development Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments within [...***...] following receipt thereof and revisions to the Development Plan shall be reviewed and discussed, in advance, by the JDC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Development Plan. Any amendment or revision to the Development Plan that provides for an increase or decrease in the number of FTEs as compared to the previous version of the may provide comments on such NIK Development Plan, which Licensee shall consider in good faith. (c) Subject to Section 2.2.2(a) or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Development Plan, or that moves forward the timetable for activities reflected in the Development Plan, shall provide for a reasonable ramp-up or wind-down period2.2.2(b), as applicable, to accommodate a smooth and orderly transition of Development activities to the amended or revised Development Plan. Each Section 2.2.2(e), each Development Plan may be amended from time to time by Licensee, provided that no such amendment shall identify the goals of the Development program contemplated thereunder and shall address Development activities related to the Licensed Compound or the Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including: take effect until (i) the budget for Development Costs (and costs Licensee provides Xxxxxxx with notice of Phase 4 Clinical Trials, if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted, including the number of FTEs (subject to Section 4.2) and the applicable FTE Rate and out-of-pocket expenses to be incurred in such calendar year (or portion thereof), and a reasonable good faith projection copy of the budget for Development Costs (and costs of Phase 4 Clinical Trialsproposed amendment, if any) for Development activities in the Development Plan after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Development Plan; (ii) clinical trials (including Phase 4 Clinical Trials but excluding Phase 3b Clinical Trials or Post-Approval Studies) Licensee provides Xxxxxxx with [...***...] to generate data for use in seeking, obtaining or maintaining Regulatory Approval review and for labeling of the Licensed Product for the Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; provide comments on such amendment and (iii) resources Licensee considers in good faith any comments made by Xxxxxxx; and provided further that no such amendment relating to a Xxxxxxx AR Mutant Activity shall take effect unless and until approved in writing by Xxxxxxx. For clarity, the approval of Xxxxxxx is not required to perform each required amend any Development activity, including Plan except as described in the scope immediately preceding sentence. (d) Prior to the commencement of any of the work [...***...], Licensee shall amend the AR Mutant Development Plan to be performed by internal resources of each of the Parties or by CROs or other permitted subcontractors, if applicable;include a budget for such activities and submit such amendment to Xxxxxxx for review pursuant to Section 2.2.2(c). (ive) milestones The Development Plan for a Program shall not contain any Development activities relating to be met[...***...], deliverables to be provided and the timeline for completion of each Development activity; (v) the members of Licensee shall not conduct any such activities during the Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (vi) design and implementation Term of regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be supplied by Otsuka for use in clinical trials in the Territorysuch Program.

Development Plans. As soon as practicable after formation of the JDC, the JDC shall prepare (a) Day One will have sole control over and approve the initial Development Plan for decision-making authority with respect to Development of the Licensed Product Compound and the Products, other than the Development and Manufacture of Takeda Products for the Initial Indication use in the formulation existing as of the Effective Date in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Development Plan is consistent with the general Development Plan outline set forth in Exhibit B attached hereto and incorporated herein (the “General Development Plan Outline”). The JDC shall prepare and approve a separate Development Plan for Development of Licensed Product for the Initial Indication in the Initial Formulation Takeda Field in the Territory and the Compound for Development of each Other Indication Product and New Formulation (if any) use in the Territorysuch Takeda Products, and shall update and amend each Development Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments and revisions to the Development Plan shall be reviewed and discussed, in advance, by the JDC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Development Plan. Any amendment or revision to the Development Plan that provides for an increase or decrease in the number of FTEs as compared to the previous version of the Development Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Development Plan, or that moves forward the timetable for activities reflected in the Development Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Development activities to the amended or revised Development Plan. Each Development Plan shall identify the goals of the Development program contemplated thereunder and shall address Development activities related to the Licensed Compound or the Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including: (i) the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted, including the number of FTEs (subject to Section 4.2) 9.4. Day One will establish a written development plan for each Product that contemplates all Clinical Trials and the applicable FTE Rate and out-of-pocket expenses to be incurred in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for other material Development activities in the Development Plan after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Development Plan; (ii) clinical trials (including Phase 4 Clinical Trials but excluding Phase 3b Clinical Trials or Post-Approval Studies) to generate data for use in seeking, obtaining or maintaining Regulatory Approval and for labeling of the Licensed Product for the Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; (iii) resources required to perform each required Development activity, including the scope of the work to be performed by internal resources or on behalf of Day One with respect to such Product in the Day One Field, including all such Development activities required to seek and obtain Regulatory Approval for such Product in the Day One Field throughout the Territory (for each Product, a “Day One Development Plan”). Day One will update each Day One Development Plan at least annually no later than [*] of each of Calendar Year for so long as Day One is undertaking material Development efforts with respect to such Product, and otherwise as frequently as may be required during such period. Day One will provide each initial Day One Development Plan and update thereto to Takeda as soon as reasonably practicable following the Parties or by CROs or other permitted subcontractors, if applicable;finalization thereof. (ivb) milestones Subject to be metSection 9.4, deliverables Takeda will have sole control over and decision-making authority with respect to be provided the Development and Manufacture of Takeda Products for the use in the Takeda Field in the Territory and the timeline for completion of each Development activity; (v) the members of the Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (vi) design and implementation of regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be supplied by Otsuka Compound for use in clinical trials such Takeda Products. Following delivery of the Takeda Development Notice, Takeda will establish a written development plan for each Takeda Product that contemplates all Clinical Trials and other material Development activities to be performed by or on behalf of Takeda with respect to such Takeda Product in the TerritoryTakeda Field, including all such Development activities required to seek and obtain Regulatory Approval for such Takeda Product in the Takeda Field throughout the Territory (for each Takeda Product, a “Takeda Development Plan”). Takeda will update each Takeda Development Plan at least annually no later than [*] of each Calendar Year for so long as Takeda is undertaking material Development efforts with respect to such Takeda Product, and otherwise as frequently as may be required during such period. Takeda will provide each initial Takeda Development Plan and update thereto to Day One as soon as reasonably practicable following the finalization thereof.

Development Plans. As soon as practicable after formation An Environmental Assessment and Finding of No Significant Impact were completed to satisfy the requirements of the JDC, the JDC shall prepare and approve the initial Development Plan National Environmental Policy Act of 1969 (NEPA) for Development of the Licensed Product for the Initial Indication in the formulation existing as of the Effective Date in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Development Plan is consistent with the general Development Plan outline set forth in Exhibit B attached hereto and incorporated herein (the “General Development Plan Outline”). The JDC shall prepare and approve a separate Development Plan for Development of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Development of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Development Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments and revisions to the Development Plan shall be reviewed and discussedshown on Exhibit “D”, in advanceincluding, by without limitation, with respect to the JDCproposed hotel development shown thereon, and Otsuka agrees discussed above in Condition 37(a). Lessee shall have the right to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Development Plan. Any amendment or revision to the Development Plan that provides for an increase or decrease in the number of FTEs as compared to the previous version of amend the Development Plan, in accordance with Condition 5, subject to appropriate NEPA review and documentation. The Lessor reserves the right to approve a General Site Plan (showing the general location of any improvements and changes in the grade or that provides topography of portions of the Premises) to be constructed on the Premises or for addition or discontinuation of tasks or activities as compared any material modifications to be made to the previous version existing improvements on the Premises. It is understood that the General Site Plan may differ from those Plans shown in Exhibit “D” due to additional operational experience and changes in public demand. If the plans substantially deviate from those Plans shown in Exhibit “D”, or include significant new circumstances or information, appropriate NEPA review and documentation will occur, otherwise it is anticipated that no further Environmental Assessments will be required. Lessee recognizes Lessor’s legal requirements to comply with NEPA, and other applicable environmental and cultural resources laws, and agrees to cooperate and assist Lessor in complying with those laws to the extent they are applicable to this lease. The Lessor does hereby agree that its approval of the General Site Plan for any such future improvements or material modifications to the existing improvements will not be unreasonably withheld, conditioned, or delayed. Upon written approval of any site plan by the Lessor, the approval of the Lessor will not be required for any change orders with respect to those plans and specifications unless such change orders materially modify the general site plan approved by the Lessor. The approval of the Lessor will not be required for the selection of contractors, architects, or other professionals used in connection with the construction of any such improvements or material modifications to the existing improvements. Lessee and its sublessees and concessionaires shall be responsible for the engineering sufficiency of such construction and modifications. It is presently anticipated that the hotel improvements indicated on the Development Plan will be considered and evaluated for development based on updated marketing plans, Lessee may elect not to construct improvements indicated on the Development Plan, or that moves forward the timetable for activities reflected in the Development Plan, and failure to construct such improvements shall provide for not be considered a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Development activities to the amended or revised Development Plan. Each Development Plan shall identify the goals of the Development program contemplated thereunder and shall address Development activities related to the Licensed Compound or the Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including: (i) the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted, including the number of FTEs (subject to Section 4.2) and the applicable FTE Rate and out-of-pocket expenses to be incurred in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for Development activities in the Development Plan after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Development Plan; (ii) clinical trials (including Phase 4 Clinical Trials but excluding Phase 3b Clinical Trials or Post-Approval Studies) to generate data for use in seeking, obtaining or maintaining Regulatory Approval and for labeling of the Licensed Product for the Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; (iii) resources required to perform each required Development activity, including the scope of the work to be performed by internal resources of each of the Parties or by CROs or other permitted subcontractors, if applicable; (iv) milestones to be met, deliverables to be provided and the timeline for completion of each Development activity; (v) the members of the Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (vi) design and implementation of regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be supplied by Otsuka for use in clinical trials in the Territorydefault hereunder.

Development Plans. As soon DEVELOPMENT of each PRODUCT shall be conducted by the Parties in conformance with a DEVELOPMENT PLAN for such PRODUCT prepared and updated by the DEVELOPMENT COMMITTEE as practicable after formation of provided herein. (a) The Parties agree that the JDC, INITIAL PRODUCT shall be the JDC shall prepare and approve the initial Development Plan for Development of the Licensed Product for the Initial Indication in the formulation existing first AERx SYSTEM to be developed under this Agreement. The Parties' intent as of the Effective Date is to obtain, as soon as practicable using DILIGENT EFFORTS, [*] the INITIAL PRODUCT that [*] of the INITIAL PRODUCT in the Territorymanagement of both post-operative (in-patient and outpatient) pain and acute exacerbations [*]. The Attached as Exhibit B is a summary DEVELOPMENT PLAN for the INITIAL PRODUCT which reflects the Parties' understanding of the DEVELOPMENT for the INITIAL PRODUCT as of the Effective Date. Promptly after the Effective Date, the DEVELOPMENT COMMITTEE shall prepare, review and submit to the Parties for approval the detailed DEVELOPMENT PLAN for the DEVELOPMENT of the INITIAL PRODUCT. (b) Upon selection of each additional ANALGESIC DRUG for DEVELOPMENT as a new DRUG PRODUCT, or selection of a new dosage form or indication to be pursued for a DRUG PRODUCT, the DEVELOPMENT COMMITTEE shall use Commercially Reasonable Efforts prepare, review and submit to ensure that the Parties for approval the initial detailed DEVELOPMENT PLAN for such initial Development Plan is consistent AERx SYSTEM. (c) After reviewing the results of the DEVELOPMENT efforts to date with respect to a particular AERx SYSTEM or PRODUCT, the DEVELOPMENT COMMITTEE shall consider appropriate changes to and shall amend the applicable DEVELOPMENT PLAN to reflect revised DEVELOPMENT and/or regulatory activities as the DEVELOPMENT COMMITTEE reasonably determines to be necessary or useful for achieving the Parties' goal of obtaining REGULATORY APPROVAL of such AERx SYSTEM or PRODUCT as soon as practicable. Notwithstanding the above, no amendment to any DEVELOPMENT PLAN shall be construed to be final until each Party has reviewed and approved any changes to the applicable BUDGET required as a result of such amendment to the DEVELOPMENT PLAN, in accordance with the general Development Plan outline set forth in Exhibit B attached hereto provisions of Section 2.4. * Certain information on this page has been omitted and incorporated herein (filed separately with the “General Development Plan Outline”)Commission. The JDC shall prepare and approve a separate Development Plan for Development of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Development of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Development Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments and revisions Confidential treatment has been requested with respect to the Development Plan shall be reviewed and discussed, in advance, by the JDC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Development Plan. Any amendment or revision to the Development Plan that provides for an increase or decrease in the number of FTEs as compared to the previous version of the Development Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Development Plan, or that moves forward the timetable for activities reflected in the Development Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Development activities to the amended or revised Development Plan. Each Development Plan shall identify the goals of the Development program contemplated thereunder and shall address Development activities related to the Licensed Compound or the Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including:omitted portions. (id) the budget for Development Costs (SB and costs of Phase 4 Clinical Trials, if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted, including the number of FTEs (subject to Section 4.2) and the applicable FTE Rate and out-of-pocket expenses to be incurred in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for Development activities in the Development Plan after such calendar year, in Aradigm will each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Development Plan; (ii) clinical trials (including Phase 4 Clinical Trials but excluding Phase 3b Clinical Trials or Post-Approval Studies) to generate data for use in seeking, obtaining or maintaining Regulatory Approval and for labeling of the Licensed Product for the Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; (iii) resources required DILIGENT EFFORTS to perform their respective obligations under each required Development activity, including the scope of the work to be performed by internal resources of each of the Parties or by CROs or other permitted subcontractors, if applicable; (iv) milestones to be met, deliverables to be provided and the timeline for completion of each Development activity; (v) the members of the Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (vi) design and implementation of regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be supplied by Otsuka for use in clinical trials in the TerritoryDEVELOPMENT PLAN.

Development Plans. As soon as practicable after formation of the JDC, the JDC shall prepare and approve the initial Development Plan for (a) All Development of the Licensed a Product for the Initial Indication by or on behalf of ImmuneOnco in the formulation existing as of ImmuneOnco Territory under this Agreement and funded by SynBio shall be conducted pursuant to a detailed written Development plan mutually agreed between the Effective Date in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Development Plan is consistent with the general Development Plan outline set forth in Exhibit B attached hereto and incorporated herein (the “General Collaboration Development Plan OutlinePlan”). The JDC shall prepare , such Development, “Collaboration Development”) that sets forth (i) the roles and approve responsibilities of each Party and a separate description of the Development Plan activities to be conducted, (ii) the estimated timeline for completion of such Development activities, (iii) an estimated budget of Licensed Product for the Initial Indication IO Development Costs by Calendar Quarter (the “Budget”) and (iv) other details of such Development activities (including all relevant Clinical Trials in the Initial Formulation in the Territory and for Development of each Other Indication Product and New Formulation (if any) in the ImmuneOnco Territory, and shall update and amend each the draft protocol of such Clinical Trials). For clarity, Collaboration Development Plan does not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of include Global Development activities not contemplated by the then-current Development PlanActivities. Amendments and revisions to the The Collaboration Development Plan shall be reviewed focused on efficiently Developing, obtaining and discussedmaintaining Regulatory Approval for and Commercialization of the Product in the ImmuneOnco Territory, while minimizing any material adverse impact on the Development, obtaining and maintaining Regulatory Approval or Commercialization of the Product in advancethe SynBio Territory. As of the Effective Date, by the JDC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions Parties have agreed to the Development Plan. Any amendment or revision to the Development Plan that provides for an increase or decrease in the number of FTEs as compared to the previous version of the initial Collaboration Development Plan, which is attached hereto as Exhibit B. From time to time, but at least once every Calendar Quarter, either Party may propose updates or that provides for addition or discontinuation of tasks or activities as compared amendments to the previous version of Collaboration Development Plan in consultation with the Development Plan, other Party and submit such proposed updated or that moves forward the timetable for activities reflected in the Development Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Development activities amended plan to the AC for review, discussion, and approval. Once approved by the AC, the updated or amended or revised Development Plan. Each Collaboration Development Plan shall identify become effective. (b) From time to time, subject to other terms and conditions of this Agreement, each Party, in its sole discretion, may develop and adopt a strategy and plan for Developing (including obtaining and maintaining Regulatory Approvals) the goals Products in its respective territory, a copy of the Development program contemplated thereunder and shall address Development activities related which will be delivered to the Licensed Compound or other Party via the Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including:AC. (ic) the budget for The Parties will coordinate alignment with respect to all material aspects of its Development Costs (and costs of Phase 4 Clinical Trials, if any) regulatory activities for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted, including the number of FTEs (subject to Section 4.2) and the applicable FTE Rate and out-of-pocket expenses to be incurred Products in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for Development activities in the Development Plan after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Development Plan; (ii) clinical trials (including Phase 4 Clinical Trials but excluding Phase 3b Clinical Trials or Post-Approval Studies) to generate data for use in seeking, obtaining or maintaining Regulatory Approval and for labeling of the Licensed Product for the Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; (iii) resources required to perform each required Development activity, including the scope of the work to be performed by internal resources of each of the Parties or by CROs or other permitted subcontractors, if applicable; (iv) milestones to be met, deliverables to be provided and the timeline for completion of each Development activity; (v) the members of the Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (vi) design and implementation of regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be supplied by Otsuka for use in clinical trials in the Territory.their respective territories. 4.4