Development Plans. Each Dynavax Program will be carried out by Dynavax pursuant to a development plan (each, a “Development Plan”) that will outline anticipated Research and Development activities to be conducted by Dynavax and [ * ]. Any estimates regarding [ * ] shall 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 Development Plan for the [ * ] TLR 7/9 Program has been agreed to by the Parties 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 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 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, 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, [ * ] 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, 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 is hereby expressly rejected.
Appears in 2 contracts
Samples: Research and Development Collaboration (Dynavax Technologies Corp), And License Agreement (Dynavax Technologies Corp)
Development Plans. Each Dynavax 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 will be carried out by Dynavax pursuant to [***], Cue shall prepare a development high level global plan for the Development of Collaboration Products under such Program in the Field for the Cue Territory, [***] (each, a the “Cue Territory Development Plan”) that will outline anticipated Research and Development activities to be conducted by Dynavax and [ * ]). Any estimates regarding [ * ] Cue shall 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 provide its initial Cue Territory Development Plan to the JDC for its review and discussion and the [ * ] TLR 7/9 Program has been agreed to by JDC shall send the Parties 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 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 shall submit such updated initial Cue Territory Development Plan to the JSC for review and commentreview. 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, [ * Within [***] 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 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 at any other time upon shall be reasonable in scope and detail (the request “LGC Territory Development Plan”), provided that, for avoidance of either Partydoubt, 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 JSC may suggest modifications, as appropriate, to reflect material scientific or commercial developments. In the event of any inconsistency between any following information shall be included in each LGC Development Plan and this Agreementeach 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 terms of this Agreement shall prevail Parties through the JDC will review and any such inconsistent portion of a discuss amendments to each Development Plan is hereby expressly rejectedPlan.
Appears in 2 contracts
Samples: Stock Purchase Agreement (Cue Biopharma, Inc.), Stock Purchase Agreement (Cue Biopharma, Inc.)
Development Plans. Each Dynavax PROSENSA Collaboration Program will be carried out by Dynavax PROSENSA pursuant to a development plan (each, a “Development Plan”) that will outline anticipated Research and Development activities to be conducted by Dynavax 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 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, 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 Development Plan for the [ * ] TLR 7/9 Program has been agreed to by the Parties and is attached hereto as Exhibit A. Development Plans for the other Dynavax Programs Exon 44 Program 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 accordance with Section 2.5. The good faith and shall prepare a 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 within [ * ] after by PROSENSA following payment by GSK of the Effective DateDMD Program 3 Initiation Payment and DMD Program 4 Initiation Payment pursuant to Section 6.2(c), unless otherwise agreed 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 JSCJSC promptly following receipt of such comments. From time to time during the Research Term [ * ]Term, Dynavax PROSENSA shall update each Development Plan (or applicable portion thereof) and shall submit such updated Development Plan to the JSC for review and comment. Dynavax PROSENSA 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, [ * ] 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, 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 is hereby expressly rejectedshall be amended on a timely basis.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Prosensa Holding B.V.), Collaboration and License Agreement (Prosensa Holding B.V.)
Development Plans. Each Dynavax Program 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 carried out by Dynavax pursuant to a responsible for the Development Plan for such Party’s respective Region. The development plan (each, a “plans for each Region will be incorporated into the overall Development Plan”. On at least a [***] basis during the Term (or more frequently as may be required), the JDC shall 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 will outline anticipated Research have not yet been included in the Development Plan and Development activities to be conducted by Dynavax Budget for a DT Co-Co Product, including the proposed timelines and [ * ]. Any estimates regarding [ * ] shall 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 [ * ] budget for such New Collaboration Development Activities set forth in the applicable New Development Plan. The initial Development Plan for the [ * ] TLR 7/9 Program has been agreed to Proposal approved by JDC (as may be amended by the Parties and is attached hereto as Exhibit A. JDC), or (b) any applicable new formulations or Indications pursuant to Section 6.4.7(a) (New Development Plans for Activities) or new Combination Products proposed by the other Dynavax Programs will be prepared JDC in accordance with Section 2.56.4.8 (Combination Products). The JDC shall review, discuss, and determine whether to present any such update to any Development Plan or Development Budget for the [ * ] will be prepared within [ * ] after the Effective Date, unless otherwise agreed approval by the JSC. From time Each such update to time during a Development Plan and corresponding Development Budget shall become effective and shall supersede the Research Term [ * ]previous Development Plan and corresponding Development Budget upon approval thereof by the JSC. Notwithstanding any provision to the contrary set forth in this Agreement, Dynavax 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 update approve the inclusion of such Development activities in the applicable Development Plan (and corresponding Development Budget). Without limiting the JDC’s rights to review and discuss and the JSC’s rights to approve each Development Plan (or applicable portion thereof) and shall submit such updated update thereto, the Party to whom a particular Development Plan to the JSC for review and comment. 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 activity is allocated under the Development Plan as to whether all of shall have the criteria (either Pre-Candidate Selection Criteriaright, Phase I Ready Criteria, [ * ] Criteria without seeking JDC review 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, and at any other time upon the request of either Party, and the JSC may suggest modifications, as appropriateapproval, to reflect material scientific or commercial developments. In make operational decisions with respect to the event performance of any inconsistency between any such Development Plan and this Agreement, activity to the terms of this Agreement shall prevail and any such inconsistent portion of a extent consistent with the then-current Development Plan is hereby expressly rejectedPlan.
Appears in 1 contract
Samples: Collaboration and License Agreement (Metagenomi Technologies, LLC)
Development Plans. Each Dynavax Program will All Development of Royalty Products (in the case of Seagen) and Development of the RC48 Licensed Product and Opt-In Products (in the case of RemeGen), in the Field to be carried out conducted by Dynavax such Party, its Affiliates and sublicensees as permitted herein shall be conducted pursuant to a written development plan (eachas amended from time to time in accordance with this Section 4.2, a the “Development Plan”). Each Party’s Development Plan shall 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) that will outline anticipated Research and Development activities to being conducted by Seagen. All Collaborative Global Trials shall be conducted pursuant to a global development plan reviewed and approved by Dynavax 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 [ * ]. Any estimates regarding [ * ] shall 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 Planeach Party’s responsibilities with respect thereto. The Each Party will prepare an initial Development Plan for the [ * ] TLR 7/9 Program has been agreed to by the Parties 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 the [ * ] will be prepared within [ * ] after following the Effective DateDate and submit such initial Development Plan to the other Party for review at the JSC. The reviewing Party shall have the right to comment on such Development Plan, unless otherwise agreed and the Developing Party shall consider in good faith any such comments. The Developing Party shall promptly provide the reviewing Party with a copy of such final Development Plan, and thereafter, from time to time, but [ * ], the Developing Party shall submit an updated or amended Development Plan to reflect any changes in such plan over the past year to the JSC for the JSC’s review, and will consider in good faith any comments made by the other Party with respect thereto. The Global Development Plan shall be reviewed [ * ] by the JSC. From time to time during the Research Term [ * ], Dynavax shall update each The Global Development Plan (may be updated or applicable portion thereof) and shall submit such updated Development Plan to amended by the JSC at any time. Notwithstanding the foregoing, but still subject to Section 4.1(a), for review and comment. 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, any New Licensed Product [ * ] Criteria or PoC Criteria= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) have been metNOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Each updated 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 Plan shall replace the of such New Licensed Product pursuant to its 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 is hereby expressly rejectedPlan.
Appears in 1 contract
Samples: License Agreement (Seagen Inc.)