JSC Functions and Powers. The JSC will be responsible generally for facilitating the Parties’ interactions under this Agreement and specifically for overseeing the Development, Manufacture and Commercialization of the COVID Products. The JSC has (i) no jurisdiction to make any amendments to this Agreement, which right is reserved to the Parties; and (ii) no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement. The principal functions of the JSC will include:
(i) overseeing the Development of Collaboration COVID Vaccine Products in accordance with the COVID R&D Plan(s);
(ii) approving Product Adjustments;
(iii) approving the development of Pathogen Combination Products;
(iv) updating the initial COVID R&D Plan to include the further Development work;
(v) discussing and agreeing the Development budgets under the COVID R&D Plan(s);
(vi) the resolution and approval of any issue and recommendation from the Parties with respect to the modification of the COVID R&D Plan(s), including but not limited to modifications of the budget and timelines;
(vii) receiving written reports or presentations from GSK and CureVac of their respective progress with the further Development of each COVID Product summarizing their Development activities and the results thereof with respect to the applicable COVID Product and discuss at meetings the status, progress, and results of the Development of the respective COVID Product;
(viii) exchanging Development Data and other technical information;
(ix) discussing and agreeing on the entry of supply agreements that provide for the supply of Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product, across the GSK Territories and the CureVac Territories;
(x) discussing and agreeing on the entry of new agreements with governments and/or non-governmental organizations regarding the Development, Manufacturing and supply of the Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product;
(xi) creating sub-committees, including the IP Sub-Committee pursuant to Section 7.6, a Commercialization sub- committee for the coordination of Commercialization activities for COVID Products by GSK in the GSK Territory and by CureVac in the CureVac Territory and a Manufacturing sub-committee for discussing COVID Product related Manufacturing and supply.
(xii) serving as a forum where each Party shall inform the other Party of any material feedb...
JSC Functions and Powers. The JSC will be responsible generally for facilitating the Parties’ interactions under this Agreement and specifically for overseeing the Development, Manufacture and Commercialization of the COVID Products. The JSC has (i) no jurisdiction to make any amendments to this Agreement, which right is reserved to the Parties; and (ii) no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement. The principal functions of the JSC will include:
(i) overseeing the Development of Collaboration COVID Vaccine Products in accordance with the COVID R&D Plan(s);
(ii) approving Product Adjustments;
(iii) approving the development of Pathogen Combination Products;
(iv) updating the initial COVID R&D Plan to include the further Development work;
(v) discussing and agreeing the Development budgets under the COVID R&D Plan(s);
(vi) the resolution and approval of any issue and recommendation from the Parties with respect to the modification of the COVID R&D Plan(s), including but not limited to modifications of the budget and timelines;
(vii) receiving written reports or presentations from GSK and CureVac of their respective progress with the further Development of each COVID Product summarizing their Development activities and the results thereof with respect to the applicable COVID Product and discuss at meetings the status, progress, and results of the Development of the respective COVID Product;
JSC Functions and Powers. The JSC shall manage the Development activities of the Parties under this Agreement. In particular, the JSC shall, subject to the other provisions of this Agreement:
(a) review, modify, and approve the Development strategy and oversee the Co-commercialization in the Co-commercialization Territory for the Licensed Product;
(b) review, modify, and approve the annual Development Plan proposed by the JPT, including all relevant timelines and the applicable Development Plan Budget (subject to Article 4.4), no later than by [* * *] of each Calendar Year for the following year;
(c) review, modify, and approve amendments to the Development Plan proposed by the JPT from time-to-time, including any amendments to the relevant timelines set forth therein;
(d) review, modify, and approve each Development Plan Budget (subject to Article 4.4), including any overspend (subject to Article 4.13);
(e) review and revise the FTE rate on an annual basis with increases not to exceed [* * *] per year;
(f) monitor the progress of each Development program under the Development Plan and each Party’s diligence in carrying out its responsibilities in connection therewith, and review, discuss and comment any results thereunder;
(g) [* * *];
(h) resolve any disputes or disagreements brought forward to it for resolution by the JPT or any of its other subcommittees;
(i) oversee the handling of any safety issues concerning the Licensed Product;
(j) serve as the first forum for the settlement of disputes or disagreements between the Parties resulting from or arising out of this Agreement or the Co-commercialization Agreement; and
(k) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth herein or as may be mutually agreed to in writing by the Parties.
JSC Functions and Powers. The responsibilities of the JSC will be as follows:
(i) encouraging and facilitating communication between the Parties with respect to the development and commercialization of Licensed Products;
(ii) reviewing and approving the overall strategy for development of Licensed Products in the Field in the Territory;
(iii) reviewing and approving the Development Plan (prepared as described in Section 5.2) and reviewing and approving updates, as appropriate, to the Development Plan;
(iv) monitoring the progress of the development of Licensed Products against the Development Plan and each Party’s diligence in carrying out its responsibilities thereunder;
(v) reviewing and discussing, but not approving, the Commercialization Plan (prepared as described in Section 6.2);
(vi) monitoring the progress of the commercialization of the Licensed Product Commercialization Plan;
(vii) coordinating the Parties’ efforts in connection with any co-promotion of Licensed Product undertaken by the Parties pursuant to Section 6.6;
(viii) establishing subcommittees on an as-needed basis (including without limitation those described in Section 3.2), and overseeing the activities of all subcommittees, and attempting to resolve disputes or disagreements arising in all such subcommittees; and
(x) and
(xi) carrying out the other duties and responsibilities described for it in this Agreement. For clarity, the JSC shall not have any oversight or authority with respect to any Next Generation Products.
JSC Functions and Powers. The responsibilities of the JSC will be as follows:
(a) encouraging and facilitating communication between the Parties with respect to the Development and Commercialization of the Product;
(b) coordinating and reviewing regulatory activities in the Territory;
(c) monitoring the progress of the Development and Commercialization of the Product in the Territory;
(d) coordinating and reviewing Company’s Commercialization activities in the Territory;
(e) coordinating and reviewing the establishment of a redundant supply chain for Products in alternative geographic locations;
(f) coordinating the transfer of vendor relationships to Company as contemplated by this Agreement;
(g) reviewing and addressing Disputes related to breach of this Agreement;
(h) establishing subcommittees on an as-needed basis, overseeing the activities of all such subcommittees and attempting to resolve disputes or disagreements arising in all such subcommittees; and
(i) carrying out the other duties and responsibilities described for it in this Agreement. The JSC may form sub-committees for execution of its responsibilities which shall be comprised of representatives appointed by the Parties. The sub-committees shall meet at such times and on such schedule as may be established by such sub-committees.
JSC Functions and Powers. The JSC will be responsible for the overall oversight of the Target Discovery Program, Target Validation Programs and Compound Discovery Programs. The principal functions of the JSC will include:
2.3.1 overseeing and monitoring the progress, results and the decision to advance Oncology Targets into the next stage of development under the Target Discovery Program, Target Validation Programs and Compound Discovery Programs, as applicable, including (a) reviewing and approving the Project Plans, annual updates thereto and any modifications thereto as may be requested by a Party from time to time, (b) overseeing, reviewing and coordinating the conduct of activities under the Project Plans and (c) tracking the activities against the applicable Project Plan;
2.3.2 determining if a Target Validation Program and/or Compound Discovery Program should be terminated for futility;
2.3.3 establishing or disbanding subcommittees and/or working groups as necessary;
2.3.4 fostering the collaborative relationship between the Parties;
2.3.5 resolving disputes between the Parties;
2.3.6 initial disclosure and/or delivery of information and technical information relating to the Oncology Targets, including identification and selection thereof, and Collaboration Targets from one Party to the other;
2.3.7 coordinating any research activities conducted by NextCure with those conducted by Lilly;
2.3.8 upon exercise of an Option, helping facilitate the transfer of materials and information to the Option-exercising Party in accordance with the applicable Project Plan to the extent necessary to develop and commercialize the Lilly Product or NextCure Product, as applicable; and
2.3.9 such other functions as agreed by the Parties.
JSC Functions and Powers. The responsibilities of the JSC will be as follows:
(i) encouraging and facilitating communication between the Parties with respect to the development and commercialization of Licensed Products;
(ii) reviewing and approving the overall strategy for development of Licensed Products in the Field in the Territory;
(iii) reviewing and approving the Development Plan (prepared as described in Section 5.2) and reviewing and approving updates, as appropriate, to the Development Plan;
(iv) monitoring the progress of the development of Licensed Products against the Development Plan and each Party’s diligence in carrying out its responsibilities thereunder;
(v) reviewing and discussing, but not approving, the Commercialization Plan (prepared as described in Section 6.2);
(vi) monitoring the progress of the commercialization of the Licensed Product Commercialization Plan;
(vii) coordinating the Parties’ efforts in connection with any co-promotion of Licensed Product undertaken by the Parties pursuant to Section 6.6;
JSC Functions and Powers. The responsibilities of the JSC shall be:
(a) to review, discuss and approve the Development Plan and amendments thereto, including, but not limited to, the CUDC-908 IND-Enabling Activities and the budget therefor;
(b) to facilitate the exchange of Curis Know-How and GBMT Know-How;
(c) to serve as a forum for GBMT to keep Curis reasonably informed regarding GBMT’s development, registration and commercialization plans, efforts and results with respect to Compounds and Products in the Field in the GBMT Territory;
(d) to seek harmonization in the parties’ respective development and Regulatory Approval efforts with respect to Compounds and Products in the Field; and
(e) to carry out such other obligations as are expressly delegated to it under this Agreement.
JSC Functions and Powers. The research activities of the Parties under the Research Plan shall be managed by the JSC only to the extent set forth herein (unless otherwise mutually agreed in writing by the Parties). The JSC shall xxxxxx the collaborative relationship between the Parties in order to assist each Party in fulfilling its obligations under the Research Plan, and shall in particular:
3.6.1. encourage and facilitate ongoing cooperation and information exchange between the Parties;
3.6.2. monitor the progress of the Research Program and the Parties’ diligence in carrying out their responsibilities thereunder, including activities directed towards achievement of the CAN Stage for the Pfizer Programs;
3.6.3. subject to Sections 3.2 and 3.3, prepare any amendments to the Research Plan, if the JSC should determine that any such amendments are necessary;
3.6.4. set priorities, allocate tasks and coordinate activities between the Parties, in each case as required to perform the Research Program; and
3.6.5. perform such other functions as appropriate to further the purposes of the Research Plan as mutually determined by the Parties. Except as set forth in Section 3.6.3, the JSC shall have no power to amend this Agreement and shall have only such powers as are specifically delegated to it in this Agreement.
JSC Functions and Powers. The JSC shall:
(a) monitor the progress of the CASI Development Plan and review and discuss any results thereunder;
(b) approve updates and amendments to the CASI Development Plan each Calendar Quarter, including all relevant timelines;
(c) serve as a forum of exchange and coordination with respect to regulatory, clinical, patent, manufacturing, and Commercialization strategies (directly or through subcommittees);
(d) serve as the first forum for the settlement of disputes or disagreements resulting from or arising out of this Agreement; and
(e) perform such other functions as appropriate to further the purposes of this Agreement, as mutually agreed to in writing by the Parties.
