Formation; Purpose. Within [***] after the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JSC shall be: (a) to review and discuss HBM’s Alpha’s performance of the HBM[***] IND-Enabling Activities, including the reports provided to the JSC by HBM Alpha pursuant to Section 4.6; (b) to approve any amendments to the Development Plan brought to the JSC pursuant to Section 4.2.1; (c) to review and discuss (but except as set forth in clause (b) above, not approve) (i) Spruce’s Exploitation of Licensed Products in the Field in the Spruce Territory and (ii) HBM Alpha’s Exploitation of Licensed Products in the HBM Alpha Territory; (d) to review and discuss (i) any Manufacture of Licensed Products by Spruce occurring in the HBM Alpha Territory and (ii) any Manufacture of Licensed by HBM Alpha occurring in the Spruce Territory; (e) to coordinate the Commercialization of Licensed Products in the Spruce Territory and HBM Alpha Territory to ensure consistent global marketing of Licensed Products in the Field; (f) to review, discuss, and resolve any Adverse Risk brought to the JSC pursuant to Section 5.3; (g) to coordinate the overall Publication strategy for Licensed Products; (h) to coordinate the overall Patent strategy for Licensed Products; and (i) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.
Appears in 1 contract
Sources: Collaboration and License Agreement (Spruce Biosciences, Inc.)
Formation; Purpose. Within [***] after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JSC shall be:
(ai) to review review, discuss and discuss HBM’s Alpha’s performance of coordinate the HBM[***] IND-Enabling Activitiesoverall strategy for the Development, including the reports provided to the JSC by HBM Alpha pursuant to Section 4.6;
(b) to approve any amendments to the Development Plan brought to the JSC pursuant to Section 4.2.1;
(c) to review Manufacturing, and discuss (but except as set forth in clause (b) above, not approve)
(i) Spruce’s Exploitation Commercialization of Licensed Products in the Field in the Spruce Territory and Kaken Territory, including related regulatory activities;
(ii) HBM Alpha’s Exploitation to review and discuss the overall strategy for Development and Manufacturing of Licensed Products in the HBM Alpha Spruce Territory that affects Development, Manufacturing, Commercialization of Licensed Products in the Field in the Kaken Territory, including related regulatory activities;
(diii) to review, discuss and approve any proposed amendments or revisions to the Territory Development Plan, including the First Supplemental Development Plan and those with respect to clinical Development activities set forth in Section 4.3(b);
(iv) to review and discuss (ibut not approve) the Commercialization Plan and any Manufacture proposed amendments or revisions to such plan, and review and discuss (but not approve) the Commercialization of Licensed Products by Spruce occurring in the HBM Alpha Territory and (ii) any Manufacture of Licensed by HBM Alpha occurring Field in the Spruce TerritoryKaken Territory (including any pricing strategy with respect to Licensed Products);
(ev) to coordinate the Commercialization of Licensed Products in the Spruce Kaken Territory and HBM Alpha Spruce Territory to ensure consistent global marketing of Licensed Products in the Field;
(f) to review, discussincluding by reviewing proposed marketing and promotional materials for use by Kaken in the Kaken Territory [***]. For clarity, Spruce will have sole authority for determining and resolve any Adverse Risk brought to establishing the JSC pursuant to Section 5.3;
(g) to coordinate price of Licensed Products in the overall Publication strategy for Licensed Products;
(h) to coordinate the overall Patent strategy for Licensed ProductsSpruce Territory; and
(ivi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.
Appears in 1 contract
Sources: Collaboration and License Agreement (Spruce Biosciences, Inc.)