Specific Responsibilities of the JSC. On an Fcab-by-Fcab and a mAb2-by-mAb2 basis, until the expiration of the License Option Term for such Accepted Fab Target, the JSC shall review the strategy for the Development of mAb2s. In particular, at each meeting the JSC shall: 2.2.1 discuss Denali’s Technical Development. 2.2.2 discuss the suitability of an Fcab Target for the generation of Fcabs and mAb2 pursuant to Section 3.1.5. 2.2.3 agree on the Fcab Discovery Plan for each Accepted Fcab Target, based on the Fcab Discovery Plan for the TfR Accepted Fcab Target which is appended as Schedule 1.51; 2.2.4 agree on (i) the Fcab Delivery Criteria for each Accepted Fcab Target, based on the Fcab Delivery Criteria for the TfR Accepted Fcab Target which are set out in Schedule 1.51; and (ii) the protocol for the validation experiment(s) required for the Fcab Delivery Criteria. 2.2.5 review and discuss the conduct of research and Development activities under each Fcab Discovery Plan, until all activities to be performed thereunder have been completed; 2.2.6 discuss the progress of research and Development activities under each mAb2 Development Plan and to agree any activities that Denali requests that F-star undertakes in relation to the conduct such mAb2 Development Plan in each case for each mAb2 until all activities to be performed thereunder have been completed; 2.2.7 agree on a policy for publications, presentations or public disclosures related to a Selected Fcab during the Buy-out Option Period and to consider any proposed publications specifically; 2.2.8 establish Working Groups as necessary; 2.2.9 perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 3 contracts
Sources: License and Collaboration Agreement (Spring Bank Pharmaceuticals, Inc.), License and Collaboration Agreement (Denali Therapeutics Inc.), License and Collaboration Agreement (Denali Therapeutics Inc.)
Specific Responsibilities of the JSC. On an Fcab-by-Fcab and a mAb2-by-mAb2 basis, until Until the expiration of the License Option Research Collaboration Term for such Accepted Fab with respect to a particular Licensed Target, the JSC shall review the strategy for and oversee the Development of mAb2sthe Licensed Compounds and Licensed Products directed to such Licensed Target. In particular, at each meeting the JSC shall:
2.2.1 discuss Denali’s Technical Development.
2.2.2 discuss the suitability of an Fcab Target for the generation of Fcabs and mAb2 pursuant to Section 3.1.5.
2.2.3 agree on the Fcab Discovery Plan activities to be included in each Research Plan;
2.2.2 establish a project team for each Accepted Fcab Target, based on the Fcab Discovery Plan for the TfR Accepted Fcab Target which is appended as Schedule 1.51Research Plan;
2.2.4 agree on (i) the Fcab Delivery Criteria for each Accepted Fcab Target, based on the Fcab Delivery Criteria for the TfR Accepted Fcab Target which are set out in Schedule 1.51; and (ii) the protocol for the validation experiment(s) required for the Fcab Delivery Criteria.
2.2.5 2.2.3 review and discuss the overall status of each Research Plan and the conduct of research and Development activities under each Fcab Discovery Research Plan;
2.2.4 review and discuss the results of each activity under each Research Plan, until all activities whether completed or ongoing;
2.2.5 review and agree to be performed thereunder have been completedany amendment to a Research Plan;
2.2.6 review and discuss the progress prosecution strategy for Silence Research Patents and Joint Research Patents, including using their Commercially Reasonable Efforts to ensure that there are or will be a commercially reasonable set of research and Development activities under Product Specific Patents directed to each mAb2 Development Plan Licensed Target and to agree any activities that Denali requests that F-star undertakes in relation Licensed Products directed to the conduct each such mAb2 Development Plan in each case for each mAb2 until all activities to be performed thereunder have been completedLicensed Target;
2.2.7 agree on a policy for publications, presentations or public disclosures related to a Selected Fcab during review and approve decisions of the Buy-out Option Period JDC and to consider resolve any proposed publications specificallyfailure to agree at the JDC;
2.2.8 establish Working Groups as necessaryreview and discuss the Manufacturing requirements for any Licensed Compounds;
2.2.9 review and determine what information will be included as part of the Research Plan Data Package, to the extent not already specified in the applicable Research Plan;
2.2.10 establish a Patent Working Group to review and discuss the prosecution strategy for Product Specific Patents and Joint Research Patents, as set out in Section 11.2;
2.2.11 establish subcommittees to perform specific duties of the JSC, direct each such subcommittee to perform the functions for which it is established, and oversee each subcommittee, including resolution of disputes raised to the JSC by any subcommittee;
2.2.12 perform such other functions functions, and direct each subcommittee to perform such other functions, as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 1 contract
Sources: Exclusive Research Collaboration, Option and License Agreement (Silence Therapeutics PLC)