Common use of Development Plans Clause in Contracts

Development Plans. Within a reasonable time prior to (but in any event no later than [***] months prior to) the anticipated completion of the Research to accomplish filing of an IND for each Program [***], Cue shall prepare a high level global plan for the Development of Collaboration Products under such Program in the Field for the Cue Territory, [***] (the “Cue Territory Development Plan”). Cue shall provide its initial Cue Territory Development Plan to the JDC for its review and discussion and the JDC shall send the initial Cue Territory Development Plan to the JSC for review. Within [***] days of the JSC’s review of the Cue Territory Development Plan for a Program, LGC shall prepare a plan for the Development (including all clinical trials) of all Collaboration Products for such Program in the Field in the LGC Territory, which plan shall be materially consistent with [***], and shall be reasonable in scope and detail (the “LGC Territory Development Plan”), provided that, for avoidance of doubt, neither Party is required to agree to a Multi-Region Trial. LGC shall provide the LGC Territory Development Plan to the JDC for its review and discussion. The Parties agree the following information shall be included in each LGC Development Plan and each Cue Development Plan [***]: (a) detailed [***]; (b) the regulatory 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. Within Each PROSENSA Collaboration Program will be carried out by PROSENSA pursuant to a reasonable time prior development plan (each, a “Development Plan”) that will outline anticipated Research and Development activities to (but in any event no later than [***] months prior to) be conducted by PROSENSA, the 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 Research relevant activities as to accomplish filing whether all of an IND 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 each the Exon 44 Program [***], Cue will be prepared by PROSENSA following the Effective Date and submitted to the JSC for comment and approval. PROSENSA shall consider all comments of the JSC in good faith and shall prepare a high level global plan for the Development of Collaboration Products under such Program in the Field for the Cue Territory, [***] (the “Cue Territory Development Plan”). Cue shall provide its initial Cue Territory final Development Plan for approval by the JSC promptly following receipt of such comments. 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 6.2(c), respectively, and submitted to the JDC JSC for its review comment and discussion approval. PROSENSA shall consider all comments of the JSC in good faith and shall prepare a final Development Plan for approval by the JDC JSC promptly following receipt of such comments. From time to time during the Research Term, PROSENSA shall send the initial Cue Territory update each Development Plan (or applicable portion thereof) and shall submit such updated Development Plan to the JSC for reviewreview and comment. Within [***] days 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’s review of the Cue Territory Development Plan for a Program, LGC shall prepare a plan for the Development (including all clinical trials) of all Collaboration Products for such Program in the Field in the LGC Territory, which plan shall be materially consistent with [***], and shall be reasonable in scope at any other time upon the request of either Party, and detail (the “LGC Territory Development Plan”)JSC may suggest modifications, provided thatas appropriate, for avoidance to reflect material scientific or commercial developments. In the event of doubt, neither Party is required to agree to a Multi-Region Trial. LGC shall provide the LGC Territory Development Plan to the JDC for its review and discussion. The Parties agree the following information shall be included in each LGC any inconsistency between any Development Plan and each Cue this Agreement, the terms of this Agreement shall prevail and any such inconsistent portion of a Development Plan [***]: (a) detailed [***]; (b) the regulatory 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 Planshall be amended on a timely basis.

Development Plans. Within (a) The Development under each Co-Commercialized Program, Split Program, or Buy-In Program shall be governed by a reasonable time prior Development Plan (the “Development Plan”) that describes the proposed overall objectives of such Licensed Program, as well as the activities to (but in any event no later than [***] months prior to) be performed, the anticipated completion of the Research to accomplish filing Party responsible for performance of an IND for each Program [***], Cue activity (which shall prepare a high level global plan for the Development of Collaboration Products under such Program be as provided in the Field for the Cue TerritorySection 3.8), [***] budget of Development Costs (“Development Budget”), and anticipated timelines for performance; provided that the “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”). Cue shall provide its initial Cue Territory , with Development Plan Budget. (b) With respect to each Co-Commercialized Program, Agios will prepare and deliver to the JDC for its review and discussion and the JDC shall send the initial Cue Territory Development Plan to the JSC for reviewas set forth in Section 3.6(b)(ii). Within [***] days of following the JSC’s Option Exercise Date with respect to such Co-Commercialized Program, the JDC shall review of and approve such initial Development Plan, with such modifications as determined by the Cue Territory 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, LGC 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 a plan [**] updates to each Development Plan for the Development (including all clinical trials) of all Collaboration Products for such each Co-Commercialized Program, Buy-In Program, and Split Program in the Field in the LGC Commercializing Party’s Territory, which plan shall be materially consistent with [***], and ] updates shall be reasonable in scope and detail (submitted for approval by the “LGC Territory Development Plan”)JDC. Subject to Section 2.8, provided that, for avoidance of doubt, neither Party is required to agree to a Multi-Region Trial. LGC shall provide the LGC Territory Development Plan to may be amended during the JDC for its review and discussion. The Parties agree the following information shall be included in each LGC Development Plan and each Cue Development Plan [***]: (a) detailed [***]; (b) ] by the regulatory 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 PlanJDC.

Development Plans. Within Each Dynavax Program will be carried out by Dynavax pursuant to a reasonable time prior to development plan (but in any event no later than [***] months prior to) the anticipated completion of the Research to accomplish filing of an IND for each Program [***]each, Cue shall prepare a high level global plan for the Development of Collaboration Products under such Program in the Field for the Cue Territory, [***] (the “Cue Territory Development Plan”)) that will outline anticipated Research and Development activities to be conducted by Dynavax and [ * ]. Cue Any estimates regarding [ * ] shall provide its be intended as a general guide only, and 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 Plan. The initial Cue Territory Development Plan for the [ * ] TLR 7/9 Program has been agreed to by the JDC Parties and is attached hereto as Exhibit A. Development Plans for its review the other Dynavax Programs will be prepared in accordance with Section 2.5. The Development Plan for 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 update each Development Plan (or applicable portion thereof) and discussion and the JDC shall send the initial Cue Territory submit such updated Development Plan to the JSC for reviewreview and comment. Within [***Dynavax shall consider all such comments in good faith before preparing an updated Development Plan, however each such Development Plan will be designed with the objective of enabling a determination upon completion of the Development Plan as to whether all of the criteria (either Pre-Candidate Selection Criteria, Phase I Ready Criteria, [ * ] days Criteria or PoC Criteria) have been met. 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’s review of the Cue Territory Development Plan for a Program, LGC shall prepare a plan for the Development (including all clinical trials) of all Collaboration Products for such Program in the Field in the LGC Territory, which plan shall be materially consistent with [***], and shall be reasonable in scope at any other time upon the request of either Party, and detail (the “LGC Territory Development Plan”)JSC may suggest modifications, provided thatas appropriate, for avoidance to reflect material scientific or commercial developments. In the event of doubt, neither Party is required to agree to a Multi-Region Trial. LGC shall provide the LGC Territory Development Plan to the JDC for its review and discussion. The Parties agree the following information shall be included in each LGC any inconsistency between any Development Plan and each Cue this Agreement, the terms of this Agreement shall prevail and any such inconsistent portion of a Development Plan [***]: (a) detailed [***]; (b) the regulatory 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 Planis hereby expressly rejected.

Development Plans. Within a reasonable time prior to (but in any event no later than [***] months prior to) the anticipated completion of the Research to accomplish filing of an IND for each Program [***], Cue Tevard shall prepare a high level global plan and deliver to the JDC, for the JDC’s review and approval, a written Development of Collaboration Products under such Program in the Field for the Cue Territory, [***] plan (the “Cue Territory Development Plan”). Cue shall provide its initial Cue Territory Development Plan to the JDC for its review and discussion and the JDC shall send the initial Cue Territory Development Plan to the JSC for review. Within [***] days of the JSC’s review of the Cue Territory Development Plan for a Program, LGC shall prepare a plan for the Development (including all clinical trials) of all Collaboration Products for such Program in the Field in the LGC Territory, which plan shall be materially consistent with [***], and shall be reasonable in scope and detail (the “LGC Territory Development Plan”), provided thatincluding the associated budget (the “Budget”), for avoidance of doubtthe Dravet Syndrome Program, neither Party is required the Second Program and any Subsequent Option Programs setting forth the discovery and research activities to agree be conducted by Tevard in connection therewith in accordance with a timeline and sufficient to a Multi-Region Trialmeet the Option Package Criteria to be prepared by the JDC. LGC shall provide the LGC Territory The initial Development Plan for the Dravet Syndrome Program is attached hereto as Exhibit H, and the initial Development Plans for the Second Program and Subsequent Option Programs will be attached hereto as Exhibit I and Exhibit J, respectively, upon approval of such Development Plans by the JDC. The JDC will, on an annual basis, prepare and approve updates to the JDC Development Plans by September 30 of each Calendar Year for its review and discussion. The Parties agree each year of the following information shall be included in each LGC Development Plan and each Cue Development Plan [***]: (a) detailed [***]; (b) the regulatory 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 [***]Research Term. From time to time, but at least every [***]time in between such annual updates, the Parties through JDC may amend the JDC will review Development Plans, consistent with the principles set forth in this Section 2.1. In the event of a conflict between the terms of this Agreement and discuss amendments to each a Development Plan, the terms of this Agreement shall govern. Without limiting the foregoing, the Development 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 fully dedicated to the Development Program and personnel whose working time will be partially dedicated to the Development 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. Within The initial Development Plan, which will set forth in reasonable detail the anticipated Development activities for the applicable DT Co-Co Products in the Territory and the corresponding Development Budget, shall be reviewed by 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. On at least a reasonable time prior to (but in any event no later than [***] months prior to) basis during the anticipated completion of the Research to accomplish filing of an IND for each Program [***]Term (or more frequently as may be required), Cue shall prepare a high level global plan for the Development of Collaboration Products under such Program in the Field for the Cue Territory, [***] (the “Cue Territory Development Plan”). Cue shall provide its initial Cue Territory Development Plan to the JDC for its review and discussion and the JDC shall send the initial Cue Territory review and 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 New Collaboration Development Activities set forth in the applicable New Development Proposal approved by JDC (as may be amended by the JDC), or (b) any applicable new formulations or Indications pursuant to Section 6.4.7(a) (New Development Activities) or new Combination Products proposed by the JDC 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 or Development 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 for reviewshall approve the inclusion of such Development activities in the applicable Development Plan (and corresponding Development Budget). Within [***] days of Without limiting the JDC’s rights to review and discuss and the JSC’s review of the Cue Territory Development Plan for a Program, LGC shall prepare a plan for the Development (including all clinical trials) of all Collaboration Products for such Program in the Field in the LGC Territory, which plan shall be materially consistent with [***], and shall be reasonable in scope and detail (the “LGC Territory Development Plan”), provided that, for avoidance of doubt, neither Party is required rights to agree to a Multi-Region Trial. LGC shall provide the LGC Territory Development Plan to the JDC for its review and discussion. The Parties agree the following information shall be included in approve each LGC Development Plan and each Cue update thereto, the Party to whom a particular Development activity is allocated under the Development Plan [***]: (a) detailed [***]; (b) shall have the regulatory strategy for right, without seeking JDC review or JSC approval, to make operational decisions with respect to the applicable Collaboration Product in each country within performance of such Development activity to the applicable Territory; (c) timelines for [***]; (d) strategy for [***], (e) [***], and (f) anticipated date of [***]. From time to time, but at least every [***], extent consistent with the Parties through the JDC will review and discuss amendments to each then-current Development Plan.

Development Plans. Within a reasonable time prior to All Development of Royalty Products (but in any event no later than [***] months prior tothe case of Seagen) the anticipated completion and Development of the Research to accomplish filing RC48 Licensed Product and Opt-In Products (in the case of an IND for each Program [***]RemeGen), Cue shall prepare a high level global plan for the Development of Collaboration Products under such Program in the Field for the Cue Territoryto be conducted by such Party, [***] its Affiliates and sublicensees as permitted herein shall be conducted pursuant to a written development plan (as amended from time to time in accordance with this Section 4.2, the “Cue Territory Development Plan”). Cue Each Party’s Development Plan shall provide its include any Territory-specific Clinical Trials planned or being conducted by such Party, including, with respect to Seagen, any Global Trial (other than a Collaborative Global Trial) being conducted by Seagen. All Collaborative Global Trials shall be conducted pursuant to a global development plan reviewed and approved by the JSC (as amended from time to time in accordance with this Section 4.2, the “Global Development Plan”). The Global Development Plan shall include each Collaborative Global Trial and shall set forth each Party’s responsibilities with respect thereto. Each Party will prepare an initial Cue Territory Development Plan within [ * ] following the Effective Date and submit such initial Development Plan to the JDC other Party for its review and discussion at the JSC. The reviewing Party shall have the right to comment on such Development Plan, and the JDC Developing Party shall send consider in good faith any such comments. The Developing Party shall promptly provide the initial Cue Territory reviewing Party with a copy of such final Development Plan to the JSC for review. Within [***] days of the JSC’s review of the Cue Territory Development Plan for a Program, LGC shall prepare a plan for the Development (including all clinical trials) of all Collaboration Products for such Program in the Field in the LGC Territory, which plan shall be materially consistent with [***]Plan, and shall be reasonable in scope and detail (the “LGC Territory Development Plan”)thereafter, provided that, for avoidance of doubt, neither Party is required to agree to a Multi-Region Trial. LGC shall provide the LGC Territory Development Plan to the JDC for its review and discussion. The Parties agree the following information shall be included in each LGC Development Plan and each Cue Development Plan [***]: (a) detailed [***]; (b) the regulatory 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 from time to time, but at least every [***[ * ], the Parties through Developing Party shall submit an updated or amended Development Plan to reflect any changes in such plan over the JDC past year to the JSC for the JSC’s review, and will review and discuss amendments consider in good faith any comments made by the other Party with respect thereto. The Global Development Plan shall be reviewed [ * ] by the JSC. The Global Development Plan may be updated or amended by the JSC at any time. Notwithstanding the foregoing, but still subject to each Section 4.1(a), for any New Licensed Product [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. for which RemeGen has received a Data Package, but does not exercise an Opt-In Right, Seagen shall not be required to conduct such further Development of such New Licensed Product pursuant to its Development Plan.