Common use of Development Plans Clause in Contracts

Development Plans. (a) The Development under each Co-Commercialized Program, Split Program, or Buy-In Program shall be governed by a Development Plan (the “Development Plan”) that describes the proposed overall objectives of such Licensed Program, as well as the activities to be performed, the Party responsible for performance of an activity (which shall be as provided in Section 3.8), [**] budget of Development Costs (“Development Budget”), and anticipated timelines for performance; provided that the Development Budget will only be applicable for periods following the Development Cost Initiation Date for such Licensed Program. In addition, if Celgene requests that Agios perform any Development activities for a Celgene Picked Validated Program and Agios consents to perform such activities, such activities shall also be governed by a Development Plan, with Development Budget. (b) With respect to each Co-Commercialized Program, Agios will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date with respect to such Co-Commercialized Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. The Development Plan for a Co-Commercialized Program shall not include a Development Budget, except for such Development activities as are to be conducted by Agios pursuant to Section 3.8. (c) With respect to each Buy-In Program, the Commercializing Party will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.11(a). Within [**] days following the Buy-In Party’s exercise of the Buy-In Right with respect to such Buy-In Program, the JDC shall approve such plan, with such modifications as determined by the JDC. (d) With respect to each Split Program, Agios will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date for such Split Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. (e) The Commercializing Party shall prepare [**] updates to each Development Plan for each Co-Commercialized Program, Buy-In Program, and Split Program in the Field in the Commercializing Party’s Territory, which [**] updates shall be submitted for approval by the JDC. Subject to Section 2.8, the Development Plan may be amended during the [**] by the JDC.

Development Plans. Each Dynavax Program will be carried out by Dynavax pursuant to a development plan (a) The Development under each Co-Commercialized Programeach, Split Program, or Buy-In Program shall be governed by a Development Plan (the “Development Plan”) that describes the proposed overall objectives of such Licensed Program, as well as the will outline anticipated Research and Development activities to be performed, the Party responsible for performance of an activity (which conducted by Dynavax and [ * ]. Any estimates regarding [ * ] shall be intended as provided in Section 3.8), [**] budget of Development Costs (“Development Budget”)a general guide only, and anticipated timelines for performance; provided that Dynavax shall continue to progress each Dynavax Program with Commercially Reasonable Efforts, even if Commercially Reasonable Efforts would require a [ * ] set forth in the Development Budget will only be applicable for periods following the Development Cost Initiation Date for such Licensed ProgramPlan. In addition, if Celgene requests that Agios perform any Development activities for a Celgene Picked Validated Program and Agios consents to perform such activities, such activities shall also be governed by a Development Plan, with Development Budget. (b) With respect to each Co-Commercialized Program, Agios will prepare and deliver to the JDC the The initial Development Plan as set forth in Section 3.6(b)(ii). Within [**for the [ * ] days following the Option Exercise Date with respect TLR 7/9 Program has been agreed to such Co-Commercialized Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDCParties and is attached hereto as Exhibit A. Development Plans for the other Dynavax Programs will be prepared in accordance with Section 2.5. The Development Plan for a Co-Commercialized Program the [ * ] will be prepared within [ * ] after the Effective Date, unless otherwise agreed by the JSC. From time to time during the Research Term [ * ], Dynavax shall not include a update each Development BudgetPlan (or applicable portion thereof) and shall submit such updated Development Plan to the JSC for review and comment. Dynavax shall consider all such comments in good faith before preparing an updated Development Plan, except for however each such Development activities as are to Plan will be conducted by Agios pursuant to Section 3.8. (c) With respect to each Buy-In Program, designed with the Commercializing Party will prepare and deliver to objective of enabling a determination upon completion of the JDC the initial Development Plan as set forth in Section 3.11(a). Within [**] days following the Buy-In Party’s exercise to whether all of the Buycriteria (either Pre-In Right with respect to such Buy-In ProgramCandidate Selection Criteria, the JDC shall approve such planPhase I Ready Criteria, with such modifications as determined by the JDC. (d[ * ] Criteria or PoC Criteria) With respect to each Split Program, Agios will prepare and deliver to the JDC the initial have been met. Each updated Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date for such Split Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. (e) The Commercializing Party shall prepare [**] updates to each Development Plan for each Co-Commercialized Program, Buy-In Program, and Split Program in the Field in the Commercializing Party’s Territory, which [**] updates shall be submitted for approval by the JDC. Subject to Section 2.8, replace the Development Plan previously in effect. Each Development Plan will be reviewed as necessary at each meeting of the JSC, and at any other time upon the request of either Party, and the JSC may be amended during suggest modifications, as appropriate, to reflect material scientific or commercial developments. In the [**] by event of any inconsistency between any Development Plan and this Agreement, the JDCterms of this Agreement shall prevail and any such inconsistent portion of a Development Plan is hereby expressly rejected.

Development Plans. Each PROSENSA Collaboration Program will be carried out by PROSENSA pursuant to a development plan (a) The Development under each Co-Commercialized Programeach, Split Program, or Buy-In Program shall be governed by a Development Plan (the “Development Plan”) that describes the proposed overall objectives of such Licensed Program, as well as the activities to be performed, the Party responsible for performance of an activity (which shall be as provided in Section 3.8), [**] budget of Development Costs (“Development Budget”), will outline anticipated Research and anticipated timelines for performance; provided that the Development Budget will only be applicable for periods following the Development Cost Initiation Date for such Licensed Program. In addition, if Celgene requests that Agios perform any Development activities for a Celgene Picked Validated Program and Agios consents to perform such activities, such activities shall also be governed by a Development Plan, with Development Budget. (b) With respect to each Co-Commercialized Program, Agios will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date with respect to such Co-Commercialized Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. The Development Plan for a Co-Commercialized Program shall not include a Development Budget, except for such Development activities as are to be conducted by Agios pursuant to Section 3.8. (c) With respect to each Buy-In ProgramPROSENSA, the Commercializing Party anticipated timelines for carrying out such activities and the criteria to be met in reaching the Program milestones to enable a determination on completion of the relevant activities as to whether all of the applicable Milestone Criteria have been met. Any estimates regarding the timelines of such activities shall be intended as a general guide only. Development Plans for the Exon 44 Program will prepare be prepared by PROSENSA following the Effective Date and deliver submitted to the JDC JSC for comment and approval. PROSENSA shall consider all comments of the initial JSC in good faith and shall prepare a final Development Plan as set forth in Section 3.11(a). Within [**] days following the Buy-In Party’s exercise of the Buy-In Right with respect to such Buy-In Program, the JDC shall approve such plan, with such modifications as determined by the JDC. (d) With respect to each Split Program, Agios will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date for such Split Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. (e) The Commercializing Party shall prepare [**] updates to each Development Plan for each Co-Commercialized Program, Buy-In Program, and Split Program in the Field in the Commercializing Party’s Territory, which [**] updates shall be submitted for approval by the JDCJSC promptly following receipt of such comments. Subject Development Plans for DMD Program 3 and DMD Program 4 will be prepared by PROSENSA following payment by GSK of the DMD Program 3 Initiation Payment and DMD Program 4 Initiation Payment pursuant to Section 2.86.2(c), respectively, and submitted to the JSC for comment and approval. PROSENSA shall consider all comments of the JSC in good faith and shall prepare a final Development Plan for approval by the JSC promptly following receipt of such comments. From time to time during the Research Term, PROSENSA shall update each Development Plan (or applicable portion thereof) and shall submit such updated Development Plan to the JSC for review and comment. PROSENSA shall consider all such comments in good faith before preparing an updated Development Plan. Each updated Development Plan shall replace the Development Plan previously in effect. Each Development Plan will be reviewed as necessary at each meeting of the JSC, and at any other time upon the request of either Party, and the JSC may suggest modifications, as appropriate, to reflect material scientific or commercial developments. In the event of any inconsistency between any Development Plan and this Agreement, the terms of this Agreement shall prevail and any such inconsistent portion of a Development Plan shall be amended during the [**] by the JDCon a timely basis.

Development Plans. Within a reasonable time prior to (abut in any event no later than [***] months prior to) The Development under each Co-Commercialized Program, Split Program, or Buy-In Program shall be governed by a Development Plan (the “Development Plan”) that describes anticipated completion of the proposed overall objectives of such Licensed Program, as well as the activities Research to be performed, the Party responsible for performance accomplish filing of an activity (which IND for each Program [***], Cue shall be as provided prepare a high level global plan for the Development of Collaboration Products under such Program in Section 3.8)the Field for the Cue Territory, [***] budget of (the “Cue Territory Development Costs (“Development BudgetPlan”), and anticipated timelines for performance; provided that the . Cue shall provide its initial Cue Territory Development Budget will only be applicable for periods following the Development Cost Initiation Date for such Licensed Program. In addition, if Celgene requests that Agios perform any Development activities for a Celgene Picked Validated Program and Agios consents to perform such activities, such activities shall also be governed by a Development Plan, with Development Budget. (b) With respect to each Co-Commercialized Program, Agios will prepare and deliver Plan to the JDC for its review and discussion and the JDC shall send the initial Cue Territory Development Plan as set forth in Section 3.6(b)(ii)to the JSC for review. Within [***] days following of the Option Exercise Date with respect to such Co-Commercialized Program, JSC’s review of the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. The Cue Territory Development Plan for a Co-Commercialized Program Program, LGC shall not include prepare a plan for the Development Budget, except (including all clinical trials) of all Collaboration Products for such Development activities as are to be conducted by Agios pursuant to Section 3.8. (c) With respect to each Buy-In Program, the Commercializing Party will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.11(a). Within [**] days following the Buy-In Party’s exercise of the Buy-In Right with respect to such Buy-In Program, the JDC shall approve such plan, with such modifications as determined by the JDC. (d) With respect to each Split Program, Agios will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date for such Split Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. (e) The Commercializing Party shall prepare [**] updates to each Development Plan for each Co-Commercialized Program, Buy-In Program, and Split Program in the Field in the Commercializing Party’s LGC Territory, which plan shall be materially consistent with [**] updates *], and shall be submitted reasonable in scope and detail (the “LGC Territory Development Plan”), provided that, for approval by avoidance of doubt, neither Party is required to agree to a Multi-Region Trial. LGC shall provide the JDC. Subject to Section 2.8, the LGC Territory Development Plan may to the JDC for its review and discussion. The Parties agree the following information shall be amended during the included in each LGC Development Plan and each Cue Development Plan [**] by *]: (a) detailed [***]; (b) the JDCregulatory strategy for the applicable Collaboration Product in each country within the applicable Territory; (c) timelines for [***]; (d) strategy for [***], (e) [***], and (f) anticipated date of [***]. From time to time, but at least every [***], the Parties through the JDC will review and discuss amendments to each Development Plan.

Development Plans. (a) The Tevard shall prepare and deliver to the JDC, for the JDC’s review and approval, a written Development under each Co-Commercialized Program, Split Program, or Buy-In Program shall be governed by a Development Plan plan (the “Development Plan”) that describes the proposed overall objectives of such Licensed Program, as well as the activities to be performed, the Party responsible for performance of an activity (which shall be as provided in Section 3.8), [**] including the associated budget of Development Costs (the “Development Budget”), and anticipated timelines for performance; provided that the Development Budget will only be applicable for periods following the Development Cost Initiation Date for such Licensed Program. In addition, if Celgene requests that Agios perform any Development activities for a Celgene Picked Validated Program and Agios consents to perform such activities, such activities shall also be governed by a Development Plan, with Development Budget. (b) With respect to each Co-Commercialized Program, Agios will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date with respect to such Co-Commercialized Dravet Syndrome Program, the JDC shall review Second Program and approve such initial Development Plan, any Subsequent Option Programs setting forth the discovery and research activities to be conducted by Tevard in connection therewith in accordance with such modifications as determined a timeline and sufficient to meet the Option Package Criteria to be prepared by the JDC. The initial Development Plan for a Co-Commercialized the Dravet Syndrome Program shall not include a Development Budgetis attached hereto as Exhibit H, except for such Development activities as are to be conducted by Agios pursuant to Section 3.8. (c) With respect to each Buy-In Program, the Commercializing Party will prepare and deliver to the JDC the initial Development Plan Plans for the Second Program and Subsequent Option Programs will be attached hereto as set forth in Section 3.11(a). Within [**] days following the Buy-In Party’s exercise Exhibit I and Exhibit J, respectively, upon approval of the Buy-In Right with respect to such Buy-In Program, the JDC shall approve such plan, with such modifications as determined by the JDC. (d) With respect to each Split Program, Agios will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date for such Split Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. (e) The Commercializing Party shall prepare [**] updates to each Development Plan for each Co-Commercialized Program, Buy-In Program, and Split Program in the Field in the Commercializing Party’s Territory, which [**] updates shall be submitted for approval Plans by the JDC. Subject The JDC will, on an annual basis, prepare and approve updates to the Development Plans by September 30 of each Calendar Year for each year of the Research Term. From time to time in between such annual updates, the JDC may amend the Development Plans, consistent with the principles set forth in this Section 2.82.1. In the event of a conflict between the terms of this Agreement and a Development Plan, the terms of this Agreement shall govern. Without limiting the foregoing, the Development Plan may Plans shall include development milestones, anticipated timelines therefor and a Budget. The Budget shall include a reasonable level of detail, including an estimated breakdown of FTEs by category (including categories of personnel whose working time will be amended during fully dedicated to the [**] by Development Program and personnel whose working time will be partially dedicated to the JDCDevelopment Program). For clarity, the FTE breakdown estimate shall be for budgeting purposes only and shall not restrict Tevard’s ability to move scientists within and between the FTE categories at its reasonable discretion, provided that Tevard does not exceed the Budget and maintains the minimum level of total FTEs.

Development Plans. (a) The initial Development under each Plan, which will set forth in reasonable detail the anticipated Development activities for the applicable DT Co-Commercialized ProgramCo Products in the Territory and the corresponding Development Budget, Split Program, or Buy-In Program shall be governed reviewed by a the JDC and presented to the JSC for approval. Subject to comments and proposed changes by the other Party, each Party will be responsible for the Development Plan (for such Party’s respective Region. The development plans for each Region will be incorporated into the “overall Development Plan”) that describes the proposed overall objectives of such Licensed Program, as well as the activities to be performed, the Party responsible for performance of an activity (which shall be as provided in Section 3.8), . On at least a [**] budget of Development Costs (“Development Budget”), and anticipated timelines for performance; provided that the Development Budget will only be applicable for periods following the Development Cost Initiation Date for such Licensed Program. In addition, if Celgene requests that Agios perform any Development activities for a Celgene Picked Validated Program and Agios consents to perform such activities, such activities shall also be governed by a Development Plan, with Development Budget. (b) With respect to each Co-Commercialized Program, Agios will prepare and deliver to the JDC the initial Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following basis during the Option Exercise Date with respect to such Co-Commercialized ProgramTerm (or more frequently as may be required), the JDC shall review and approve update each Development Plan and corresponding Development Budget based on the currently available information and data, including to add (a) any New Collaboration Development Activities that have not yet been included in the Development Plan and Development Budget for a DT Co-Co Product, including the proposed timelines and budget for such initial New Collaboration Development Plan, with such modifications Activities set forth in the applicable New Development Proposal approved by JDC (as determined may be amended by the JDC. The Development Plan for a Co-Commercialized Program shall not include a Development Budget), except for such Development activities as are to be conducted by Agios or (b) any applicable new formulations or Indications pursuant to Section 3.8. 6.4.7(a) (cNew Development Activities) With respect to each Buy-In Program, the Commercializing Party will prepare and deliver to or new Combination Products proposed by the JDC the initial in accordance with Section 6.4.8 (Combination Products). The JDC shall review, discuss, and determine whether to present any such update to any Development Plan as set forth in Section 3.11(a). Within [**] days following the Buy-In Party’s exercise of the Buy-In Right with respect to such Buy-In Program, the JDC shall approve such plan, with such modifications as determined by the JDC. (d) With respect to each Split Program, Agios will prepare and deliver to the JDC the initial or Development Plan as set forth in Section 3.6(b)(ii). Within [**] days following the Option Exercise Date for such Split Program, the JDC shall review and approve such initial Development Plan, with such modifications as determined by the JDC. (e) The Commercializing Party shall prepare [**] updates to each Development Plan for each Co-Commercialized Program, Buy-In Program, and Split Program in the Field in the Commercializing Party’s Territory, which [**] updates shall be submitted Budget for approval by the JSC. Each such update to a Development Plan and corresponding Development Budget shall become effective and shall supersede the previous Development Plan and corresponding Development Budget upon approval thereof by the JSC. Notwithstanding any provision to the contrary set forth in this Agreement, if either Party proposes to include Development activities for a DT Co-Co Product for a particular formulation or Indication in the applicable Development Plan because those Development activities are required or requested by a Regulatory Authority in the Territory, then the JSC shall approve the inclusion of such Development activities in the applicable Development Plan (and corresponding Development Budget). Without limiting the JDC. Subject ’s rights to Section 2.8review and discuss and the JSC’s rights to approve each Development Plan and update thereto, the Party to whom a particular Development activity is allocated under the Development Plan may be amended during shall have the [**] by right, without seeking JDC review or JSC approval, to make operational decisions with respect to the JDCperformance of such Development activity to the extent consistent with the then-current Development Plan.