Common use of Development Plans Clause in Contracts

Development Plans. For the First Licensed Compound, the initial Development Plans through and including one Phase 2a Clinical Trial with respect thereto are attached hereto as Exhibit C and Exhibit D (as may be amended from time to time upon mutual agreement of the Parties, the “Development Plans,” including the “Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectively). The Parties agree and acknowledge that these initial Development Plans reflect, as of the Execution Date, SYNTA’s good faith estimates of Development activities and the timing, internal costs, and external costs associated with such activities, all of which may be subject to change. With respect to the further Development of the relevant First Licensed Compound or following the approval for advancement into Development of any subsequent Licensed Compound, SYNTA and ROCHE, under the guidance of the JRDC, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities in the Territory for such Licensed Compound for the next twelve (12) month period. An updated Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to the beginning of each such subsequent twelve (12) month period. The Development Plan shall be consistent with the terms and conditions of this Agreement, and shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities to be performed with respect to a Licensed Compound, including Initiation of Clinical Trials, (c) the Party responsible for performance of an activity, (d) the number and types of FTEs to be assigned to specific activities by SYNTA, (e) anticipated costs to be incurred under the Development Plans (the “Budget”) for the applicable twelve (12) month period, and (f) Development timelines. For the sake of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, may be amended except by mutual agreement of the Parties.

Development Plans. For As soon as practicable after formation of the First Licensed CompoundJDC, the JDC shall prepare and approve the initial Development Plans through and including one Phase 2a Clinical Trial 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 respect thereto are the general Development Plan outline set forth in Exhibit B attached hereto as Exhibit C and Exhibit D incorporated herein (as may be amended from time to time upon mutual agreement of the Parties, the “Development Plans,” including the “General Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectivelyOutline”). The Parties agree JDC shall prepare and acknowledge that these initial approve a separate Development Plans reflectPlan 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 of the Execution Dateneeded to take into account changed circumstances or completion, SYNTA’s good faith estimates commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments and revisions to the timingDevelopment Plan shall be reviewed and discussed, internal costsin advance, by the JDC, and external costs associated with such activities, all of which may be subject Otsuka agrees to change. With respect consider proposals and suggestions made by Acucela regarding amendments and revisions to the further 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 relevant First 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 following the approval Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including: (i) the budget for advancement into Development Costs (and costs of any subsequent Licensed CompoundPhase 4 Clinical Trials, SYNTA if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and ROCHEexpenses among the activities expected to be conducted, under including the guidance 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 JRDCbudget for Development Costs (and costs of Phase 4 Clinical Trials, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. if any) for Development activities in the Territory 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 such use in seeking, obtaining or maintaining Regulatory Approval and for labeling of the Licensed Compound Product for the next twelve Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; (12iii) month period. An updated resources required to perform each required Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to activity, including the beginning scope of each such subsequent twelve (12) month period. The Development Plan shall be consistent with the terms and conditions of this Agreement, and shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities work to be performed with respect by internal resources of each of the Parties or by CROs or other permitted subcontractors, if applicable; (iv) milestones to a Licensed Compoundbe met, including Initiation deliverables to be provided and the timeline for completion of Clinical Trials, each Development activity; (cv) the Party responsible for performance members of an activitythe Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (dvi) the number design and types implementation of FTEs regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be assigned to specific activities supplied by SYNTA, (e) anticipated costs to be incurred under Otsuka for use in clinical trials in the Development Plans (the “Budget”) for the applicable twelve (12) month period, and (f) Development timelines. For the sake of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, may be amended except by mutual agreement of the PartiesTerritory.

Development Plans. For An Environmental Assessment and Finding of No Significant Impact were completed to satisfy the First Licensed Compound, the initial Development Plans through and including one Phase 2a Clinical Trial with respect thereto are attached hereto as Exhibit C and Exhibit D (as may be amended from time to time upon mutual agreement requirements of the Parties, National Environmental Policy Act of 1969 (NEPA) for the “Development Plans,” including the “Development Plan — Pre-IND” and shown on Exhibit “Development Plan — Phase 1 and Phase 2a,” respectively). The Parties agree and acknowledge that these initial Development Plans reflectD”, as of the Execution Dateincluding, SYNTA’s good faith estimates of Development activities and the timingwithout limitation, internal costs, and external costs associated with such activities, all of which may be subject to change. With respect to the further proposed hotel development shown thereon, and discussed above in Condition 37(a). Lessee shall have the right to 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 topography of portions of the relevant First Licensed Compound Premises) to be constructed on the Premises or following for any material modifications to be made to the 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 for advancement into Development of any subsequent Licensed Compound, SYNTA and ROCHE, under the guidance of the JRDC, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities in the Territory Lessor will not be required for such Licensed Compound for the next twelve (12) month period. An updated Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to the beginning of each such subsequent twelve (12) month period. The Development Plan shall be consistent with the terms and conditions of this Agreement, and shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities to be performed any change orders with respect to a Licensed Compoundthose 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, including Initiation architects, or other professionals used in connection with the construction of Clinical Trials, (c) any such improvements or material modifications to the Party existing improvements. Lessee and its sublessees and concessionaires shall be responsible for performance the engineering sufficiency of an activity, (d) such construction and modifications. It is presently anticipated that the number and types of FTEs to be assigned to specific activities by SYNTA, (e) anticipated costs to be incurred under hotel improvements indicated on the Development Plans (Plan will be considered and evaluated for development based on updated marketing plans, Lessee may elect not to construct improvements indicated on the “Budget”) for the applicable twelve (12) month periodDevelopment Plan, and (f) Development timelines. For the sake of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, may failure to construct such improvements shall not be amended except by mutual agreement of the Partiesconsidered a default hereunder.

Development Plans. (a) All Development of a Product by or on behalf of ImmuneOnco in the ImmuneOnco Territory under this Agreement and funded by SynBio shall be conducted pursuant to a detailed written Development plan mutually agreed between the Parties (the “Collaboration Development Plan”, such Development, “Collaboration Development”) that sets forth (i) the roles and responsibilities of each Party and a description of the Development activities to be conducted, (ii) the estimated timeline for completion of such Development activities, (iii) an estimated budget of the IO Development Costs by Calendar Quarter (the “Budget”) and (iv) other details of such Development activities (including all relevant Clinical Trials in the ImmuneOnco Territory, and the draft protocol of such Clinical Trials). For clarity, Collaboration Development does not include Global Development Activities. The Collaboration Development Plan shall be focused on efficiently Developing, obtaining and maintaining Regulatory Approval for and Commercialization of the First Licensed CompoundProduct in the ImmuneOnco Territory, while minimizing any material adverse impact on the Development, obtaining and maintaining Regulatory Approval or Commercialization of the Product in the SynBio Territory. As of the Effective Date, the Parties have agreed to the initial Collaboration Development Plans through and including one Phase 2a Clinical Trial with respect thereto are Plan, which is attached hereto as Exhibit C and Exhibit D (as may be amended from B. From time to time upon mutual agreement of time, but at least once every Calendar Quarter, either Party may propose updates or amendments to the PartiesCollaboration Development Plan in consultation with the other Party and submit such proposed updated or amended plan to the AC for review, discussion, and approval. Once approved by the AC, the “Development Plans,” including the “Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectively). The Parties agree and acknowledge that these initial Development Plans reflect, as of the Execution Date, SYNTA’s good faith estimates of Development activities and the timing, internal costs, and external costs associated with such activities, all of which may be subject to change. With respect to the further Development of the relevant First Licensed Compound updated or following the approval for advancement into Development of any subsequent Licensed Compound, SYNTA and ROCHE, under the guidance of the JRDC, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities in the Territory for such Licensed Compound for the next twelve (12) month period. An updated Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to the beginning of each such subsequent twelve (12) month period. The amended Collaboration Development Plan shall be consistent with the 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 shall adopt a strategy and plan for Developing (including obtaining and maintaining Regulatory Approvals) the Products in its respective territory, a copy of which will be subject delivered to review and approval by the JRDC and other Party via the JSC. AC. (c) The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities to be performed Parties will coordinate alignment with respect to a Licensed Compound, including Initiation all material aspects of Clinical Trials, (c) the Party responsible for performance of an activity, (d) the number its Development and types of FTEs to be assigned to specific regulatory activities by SYNTA, (e) anticipated costs to be incurred under the Development Plans (the “Budget”) for the applicable twelve (12) month period, and (f) Development timelinesProducts in their respective territories. For the sake of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, may be amended except by mutual agreement of the Parties.4.4

Development Plans. For the First Licensed Compound, the initial Development Plans through (a) Day One will have sole control over and including one Phase 2a Clinical Trial decision-making authority with respect thereto are attached hereto as Exhibit C and Exhibit D (as may be amended from time to time upon mutual agreement of the Parties, the “Development Plans,” including the “Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectively). The Parties agree and acknowledge that these initial Development Plans reflect, as of the Execution Date, SYNTA’s good faith estimates of Development activities and the timing, internal costs, and external costs associated with such activities, all of which may be subject to change. With respect to the further Development of the relevant First Licensed Compound or following and the approval Products, other than the Development and Manufacture of Takeda Products for advancement into Development of any subsequent Licensed Compound, SYNTA and ROCHE, under the guidance of use in the JRDC, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities Takeda Field in the Territory for such Licensed and the Compound for the next twelve (12) month perioduse in such Takeda Products, subject to Section 9.4. An updated Development Plan Day One will establish a written development plan for each subsequent twelve (12) month period will be prepared by SYNTA Product that contemplates all Clinical Trials and ROCHE at least [***] ([***]) days prior to the beginning of each such subsequent twelve (12) month period. The other material Development Plan shall be consistent with the terms and conditions of this Agreement, and shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities to be performed by or on behalf of Day One with respect to a Licensed Compoundsuch Product in the Day One Field, including Initiation 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 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 finalization thereof. (b) Subject to Section 9.4, Takeda will have sole control over and decision-making authority with respect to the Development and Manufacture of Takeda Products for the use in the Takeda Field in the Territory and the Compound for use in 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, (c) the Party responsible for performance of an activity, (d) the number Trials and types of FTEs other material Development activities to be assigned performed by or on behalf of Takeda with respect to specific such Takeda Product in the Takeda Field, including all such Development activities by SYNTArequired to seek and obtain Regulatory Approval for such Takeda Product in the Takeda Field throughout the Territory (for each Takeda Product, (e) anticipated costs 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 be incurred under the Development Plans (the “Budget”) for the applicable twelve (12) month periodsuch Takeda Product, and (f) Development timelinesotherwise as frequently as may be required during such period. For the sake of clarity, neither the Takeda will provide each initial Development Plans attached hereto, nor any subsequent Takeda Development Plan once agreed by and update thereto to Day One as soon as reasonably practicable following the Parties, may be amended except by mutual agreement of the Partiesfinalization thereof.

Development Plans. For As soon as practicable after formation of the First Licensed CompoundJDC, the JDC shall prepare and approve the initial Development Plans through and including one Phase 2a Clinical Trial 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 respect thereto are the general Development Plan outline set forth in Exhibit B attached hereto as Exhibit C and Exhibit D incorporated herein (as may be amended from time to time upon mutual agreement of the Parties, the “Development Plans,” including the “General Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectivelyOutline”). The Parties agree JDC shall prepare and acknowledge that these initial approve a separate Development Plans reflectPlan 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 of the Execution Dateneeded to take into account changed circumstances or completion, SYNTA’s good faith estimates commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments and revisions to the timingDevelopment Plan shall be reviewed and discussed, internal costsin advance, by the JDC, and external costs associated with such activities, all of which may be subject Otsuka agrees to change. With respect consider proposals and suggestions made by Acucela regarding amendments and revisions to the further 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 relevant First 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 following the approval Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including: (i) the budget for advancement into Development Costs (and costs of any subsequent Licensed CompoundPhase 4 Clinical Trials, SYNTA if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and ROCHEexpenses among the activities expected to be conducted, under including the guidance 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 JRDCbudget for Development Costs (and costs of Phase 4 Clinical Trials, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. if any) for Development activities in the Territory 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 such use in seeking, obtaining or maintaining Regulatory Approval and for labeling of the Licensed Compound Product for the next twelve Initial Indication in the Initial Formulation or, if applicable, Other Indication Product or New Formulation, including study protocol design; (12iii) month period. An updated resources required to perform each required Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to activity, including the beginning scope of each such subsequent twelve (12) month period. The Development Plan shall be consistent with the terms and conditions of this Agreement, and shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities work to be performed with respect by internal resources of each of the Parties or by CROs or other permitted subcontractors, if applicable; (iv) milestones to a Licensed Compoundbe met, including Initiation deliverables to be provided and the timeline for completion of Clinical Trials, each Development activity; (cv) the Party responsible for performance members of an activitythe Development team, which must include at least one individual who has sufficient expertise and experience in ophthalmology drug development in the Initial Indication; (dvi) the number design and types implementation of FTEs regulatory strategy; and (vii) forecasts of quantities of Licensed Product to be assigned to specific activities supplied by SYNTA, (e) anticipated costs to be incurred under Otsuka for use in clinical trials in the Development Plans (the “Budget”) for the applicable twelve (12) month period, and (f) Development timelines. For the sake of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, may be amended except by mutual agreement of the PartiesTerritory.

Development Plans. For (a) Confidential Treatment Requested Licensee shall prepare and deliver to Xxxxxxx within [...***...] after the First Licensed CompoundEffective Date a written development plan for the AR Mutant Program describing the activities to 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 activities, target dates and estimated timelines for completion of such activities and a budget for such activities (the “AR Mutant Development Plan”). The Development Plan for the AR Mutant Program shall at all times contain [...***...]. Xxxxxxx shall review the initial AR Mutant Development Plans through 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 deliver to Xxxxxxx within [...***...] after the Effective Date a written development plan for the NIK Program describing the activities to be performed to up to and including one Phase 2a Clinical Trial with respect thereto are attached hereto 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 the NIK Program shall at all times contain: [...***...]. Xxxxxxx shall review the initial NIK Development Plan within [...***...] following receipt thereof and may provide comments on such NIK Development Plan, which Licensee shall consider in good faith. (c) Subject to Section 2.2.2(a) or 2.2.2(b), as Exhibit C applicable, and Exhibit D (as Section 2.2.2(e), each Development Plan may be amended from time to time upon mutual agreement by Licensee, provided that no such amendment shall take effect until (i) Licensee provides Xxxxxxx with notice of and a copy of the Partiesproposed amendment, (ii) Licensee provides Xxxxxxx with [...***...] to review and provide comments on such amendment and (iii) 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 “Development Plans,” including the “approval of Xxxxxxx is not required to amend any Development Plan — Pre-IND” and “except as described in the immediately preceding sentence. (d) Prior to the commencement of any of the [...***...], Licensee shall amend the AR Mutant Development Plan — Phase 1 and Phase 2a,” respectively). The Parties agree and acknowledge that these initial Development Plans reflect, as of the Execution Date, SYNTA’s good faith estimates of Development to include a budget for such activities and the timing, internal costs, and external costs associated with submit such activities, all of which may be subject amendment to change. With respect to the further Development of the relevant First Licensed Compound or following the approval Xxxxxxx for advancement into Development of any subsequent Licensed Compound, SYNTA and ROCHE, under the guidance of the JRDC, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission review pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities in the Territory for such Licensed Compound for the next twelve Section 2.2.2(c). (12e) month period. An updated The Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least a Program shall not contain any Development activities relating to [...***] ([***...]) days prior to the beginning of each such subsequent twelve (12) month period. The Development Plan shall be consistent with the terms and conditions of this Agreement, and Licensee shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing not conduct any such activities to be performed with respect to a Licensed Compound, including Initiation of Clinical Trials, (c) the Party responsible for performance of an activity, (d) the number and types of FTEs to be assigned to specific activities by SYNTA, (e) anticipated costs to be incurred under during the Development Plans (the “Budget”) for the applicable twelve (12) month period, and (f) Development timelines. For the sake Term of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, may be amended except by mutual agreement of the Partiessuch Program.

Development Plans. For DEVELOPMENT of each PRODUCT shall be conducted by the First Licensed Compound, Parties in conformance with a DEVELOPMENT PLAN for such PRODUCT prepared and updated by the initial Development Plans through and including one Phase 2a Clinical Trial with respect thereto are attached hereto DEVELOPMENT COMMITTEE as Exhibit C and Exhibit D provided herein. (as may be amended from time to time upon mutual agreement of the Parties, the “Development Plans,” including the “Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectively). a) The Parties agree and acknowledge that these initial Development Plans reflect, the INITIAL PRODUCT shall be the first AERx SYSTEM to be developed under this Agreement. The Parties' intent as of the Execution Effective Date is to obtain, as soon as practicable using DILIGENT EFFORTS, [*] the INITIAL PRODUCT that [*] of the INITIAL PRODUCT in the management of both post-operative (in-patient and outpatient) pain and acute exacerbations [*]. 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, SYNTA’s good faith estimates the DEVELOPMENT COMMITTEE shall prepare, review and submit to the Parties for approval the detailed DEVELOPMENT PLAN for the DEVELOPMENT of Development activities 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 prepare, review and submit to the timing, internal costs, and external costs associated Parties for approval the initial detailed DEVELOPMENT PLAN for such AERx SYSTEM. (c) After reviewing the results of the DEVELOPMENT efforts to date with such activities, all of which may be subject to change. With respect to a particular AERx SYSTEM or PRODUCT, the further Development 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 relevant First Licensed Compound or following above, no amendment to any DEVELOPMENT PLAN shall be construed to be final until each Party has reviewed and approved any changes to the approval for advancement into Development applicable BUDGET required as a result of any subsequent Licensed Compoundsuch amendment to the DEVELOPMENT PLAN, SYNTA and ROCHE, under in accordance with the guidance provisions of the JRDC, shall prepare initial or updated Development Plans directed to Portions of Section 2.4. * Certain information on this Exhibit were page has been omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Commission. Confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities in the Territory for such Licensed Compound for the next twelve (12) month period. An updated Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to the beginning of each such subsequent twelve (12) month period. The Development Plan shall be consistent with the terms and conditions of this Agreement, and shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities to be performed has been requested with respect to a Licensed Compound, including Initiation of Clinical Trials, (c) the Party responsible for performance of an activity, omitted portions. (d) the number SB and types of FTEs Aradigm will each use DILIGENT EFFORTS to be assigned to specific activities by SYNTA, (e) anticipated costs to be incurred perform their respective obligations under the Development Plans (the “Budget”) for the applicable twelve (12) month period, and (f) Development timelines. For the sake of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, may be amended except by mutual agreement of the Partieseach DEVELOPMENT PLAN.

Development Plans. For The Lessee shall be guided by an annual Plan of Operation and Maintenance in furtherance of the First Licensed CompoundLessee's implementing Plan of Recreation Development and Management (Development Plan), which shows the facilities and services necessary to meet the current and potential public demand and the management and development activities to be undertaken by the Lessee and any sublessees. No later than October 1st of each year, the initial Development Lessee will submit the annual Plan to be mutually agreed on between the Lessee and the District Engineer. Such annual Plan shall include but is not limited to the following: a. Plans through for management, maintenance and including one Phase 2a Clinical Trial with respect thereto are attached hereto as Exhibit C development activities to be undertaken by the Lessee and Exhibit D (as may be amended from time to time upon mutual agreement any sublessees. b. A mutually acceptable schedule for use of the PartiesLease Premises by Xxxxxx and Lessor for the upcoming year. c. Report of the management, maintenance and development accomplishments of the “Lessee for the preceding year. d. Report on any significant modification of policies or procedures which are planned for the following year as well as those implemented in the preceding year. e. Minor modifications to the Development Plans,” including Plan. Major modifications are to be accomplished by amendment to the “Development Plan — Pre-IND” before proceeding to implement any changes in the development or management of the leased premises. f. Annual certification that all water and “Development Plan — Phase 1 sanitary systems on the premises have been inspected and Phase 2a,” respectively)comply with federal, state and local standards. The Parties agree Xxxxxx will also provide a statement of compliance with the Rehabilitations Act and acknowledge that these initial Development Plans reflectthe Americans with Disabilities Act, as required in the Condition on NON-DISCRIMINATION, noting any deficiencies and providing a schedule for correction. g. The use and occupation of the Execution Date, SYNTA’s good faith estimates of Development activities and the timing, internal costs, and external costs associated with such activities, all of which may be subject to change. With respect to the further Development of the relevant First Licensed Compound or following the approval for advancement into Development of any subsequent Licensed Compound, SYNTA and ROCHE, under the guidance of the JRDC, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities in the Territory for such Licensed Compound for the next twelve (12) month period. An updated Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to the beginning of each such subsequent twelve (12) month period. The Development Plan shall be consistent with the terms and conditions of this Agreement, and premises shall be subject to review the general supervision and approval by of the JRDC District Engineer. During the Term of the Lease, the District Engineer will notify the Lessee of any updates to the existing Installation Master Plan affecting the premises and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities to be performed with respect to a Licensed Compound, including Initiation of Clinical Trials, (c) the Party responsible for performance of an activity, (d) the number and types of FTEs to be assigned to specific activities by SYNTA, (e) anticipated costs to be incurred under the Development Plans (the “Budget”) for the applicable twelve (12) month period, and (f) Development timelines. For the sake of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, Lessee may be amended except by mutual agreement of the Partiesprovide comments.