Common use of Responsibilities of Steering Committee Clause in Contracts

Responsibilities of Steering Committee. The Steering Committee shall, subject to the provisions set forth in Article 4 and Article 5 hereinafter and the dispute resolution procedures of Article 16, be the primary vehicle for interaction between the Parties with respect to the development, commercialization, and marketing of the Licensed Product in the Field in the Territory. In particular, the Steering Committee shall perform the following functions consistent with its objective of managing an effective and efficient Combined Phase III Clinical Trial that satisfies the development, regulatory and commercialization requirements of North America and the Territory and leverages the clinical development activities in both territories: (I) exchange of information and facilitation of cooperation and coordination between the Parties as they exercise their respective rights and meet their respective obligations under this Agreement; (II) manage, review and monitor execution of the European Development and Commercialization Plan; (III) review, prepare and recommend changes to the European Development and Commercialization Plan; (IV) facilitate coordination of information flow, consistent with the EU privacy directive, with respect to regulatory approvals from the appropriate regulatory authorities in the Territory; and ensuring compliance in all material respects with all applicable laws, regulations, and all other requirements of applicable good laboratory practices; (V) establish, monitor, review and modify all development time lines to be adhered to by the Parties for all Phase III and Phase IV clinical development and Regulatory Approval activities in the Territory; (VI) approve all contracts, agreements, commitments and undertakings with Third Parties regarding Phase III and Phase IV clinical development activities in the Territory where the committed expenditures exceed a threshold amount to be determined by the Steering Committee; (VII) facilitate coordination of information flow with respect to the Combined Phase III Clinical Trials and Phase IV Studies (if any) between the EU and North America; (VIII) facilitate coordination of supply of Clinical Supplies for EU activities; (IX) [**********] relating to material business, scientific, clinical, medical, regulatory or management issues arising out of this Agreement in accordance with Section 16.1; and Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. (X) perform such other functions as appropriate to further the purposes of this Agreement, as determined by the mutual agreement of the Parties.

Responsibilities of Steering Committee. The Steering Committee shall, subject to the provisions set forth in Article 4 and Article 5 hereinafter and the dispute resolution procedures of Article 16, shall be the primary vehicle for interaction between the Parties with respect to the development, commercialization, and marketing of the Licensed Product in the Field in the TerritoryDevelopment Collaboration. In particular, the Steering Committee shall perform the following functions consistent with its objective of managing an effective and efficient Combined Phase III Clinical Trial that satisfies the development, regulatory and commercialization requirements of North America and the Territory and leverages the clinical development activities in both territoriesfunctions: (Ia) exchange Oversee the Development Collaboration, including establishment of information the Development Plan and facilitation review of cooperation draft study protocols for Clinical Trials of Product for Crohn’s disease, with the goal of: (i) coordinating Development such that XXXX and coordination between XXXXXXXX are each responsible for Clinical Trials of Product for Crohn’s disease on approximately 50% of the Parties as they exercise their respective rights aggregate number of patients required for the Initial Regulatory Approvals in the United States and meet their respective obligations under Europe, and (ii) in the event additional Development is required to be conducted after the Effective Date in order to obtain additional Pre-Clinical Data required for such Initial Regulatory Approvals, approving a Development Plan and budget and allocating responsibility for conducting such Development; in each case consistent with the terms and overall intents and purposes of this Agreement; (IIb) manageFacilitate the exchange of Pre-Clinical Data, review Clinical Data and monitor execution other information; (c) Review regulatory communications and strategies; (d) Discuss manufacturing and supply issues, including scale-up of manufacturing process and Product formulation and improvements; (e) Evaluate Commercialization strategies and post-marketing studies for Product for Crohn’s disease; and (f) Serve as the European initial forum for resolving disputes, it being agreed however, that each of XXXX and CORONADO, in light of their rights and obligations under this Agreement related to the Development and Commercialization Plan; in their Respective Territories, will retain final decision-making authority according to (IIIand subject to OVAMED’s rights under) review, prepare the OVAMED XXXX License and recommend changes to the European Development and Commercialization Plan; (IV) facilitate coordination of information flow, consistent with the EU privacy directive, with respect to regulatory approvals from the appropriate regulatory authorities in the Territory; and ensuring compliance in all material respects with all applicable laws, regulations, and all other requirements of applicable good laboratory practices; (V) establish, monitor, review and modify all development time lines to be adhered to by the Parties for all Phase III and Phase IV clinical development and Regulatory Approval activities in the Territory; (VI) approve all contracts, agreements, commitments and undertakings with Third Parties regarding Phase III and Phase IV clinical development activities in the Territory where the committed expenditures exceed a threshold amount to be determined by the Steering Committee; (VII) facilitate coordination of information flow OVAMED CORONADO Agreements with respect to the Combined Phase III Clinical Trials XXXX Territory and Phase IV Studies (if any) between the EU CORONADO Territory, respectively; provided, however, that the Steering Committee shall attempt in good faith to reach agreement with respect to matters that come before it for decision and North America; (VIII) facilitate coordination of supply of Clinical Supplies for EU activities; (IX) [**********] relating to material business, scientific, clinical, medical, regulatory or management issues arising out of this Agreement in accordance with Section 16.1; and Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant shall give consideration to the Company's application requesting confidential treatment under Rule 406 views, positions and recommendations of the Securities Acteach Party on such matters. (X) perform such other functions as appropriate to further the purposes of this Agreement, as determined by the mutual agreement of the Parties.

Responsibilities of Steering Committee. The Steering Committee shall, subject to the provisions set forth in Article 4 and Article 5 hereinafter and the dispute resolution procedures of Article 16, be the primary vehicle for interaction between the Parties with respect to the development, commercialization, and marketing of the Licensed Product in the Field in the Territory. In particular, the Steering Committee shall perform the following functions consistent with its objective of managing an effective and efficient Combined Phase III Clinical Trial that satisfies the development, regulatory and commercialization requirements of North America and the Territory and leverages the clinical development activities in both territories: (Ii) exchange of information and facilitation of cooperation and coordination between the Parties as they exercise their respective rights and meet their respective obligations under this Agreement; (IIii) manage, review and monitor execution of the European Development and Commercialization Plan; (IIIiii) review, prepare and recommend changes to the European Development and Commercialization Plan; (IViv) facilitate coordination of information flow, consistent with the EU privacy directive, with respect to regulatory approvals from the appropriate regulatory authorities in the Territory; and ensuring compliance in all material respects with all applicable laws, regulations, and all other requirements of applicable good laboratory practices; (Vv) establish, monitor, review and modify all development time lines to be adhered to by the Parties for all Phase III and Phase IV clinical development and Regulatory Approval activities in the Territory; (VIvi) approve all contracts, agreements, commitments and undertakings with Third Parties regarding Phase III and Phase IV clinical development activities in the Territory where the committed expenditures exceed a threshold amount to be determined by the Steering Committee; (VIIvii) facilitate coordination of information flow with respect to the Combined Phase III Clinical Trials and Phase IV Studies (if any) between the EU and North America; (VIIIviii) facilitate coordination of supply of Clinical Supplies for EU activities; (IXix) [**********] relating to material business, scientific, clinical, medical, regulatory or management issues arising out of this Agreement in accordance with Section 16.1; and Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 of the Securities ActOF THE SECURITIES ACT. (Xx) perform such other functions as appropriate to further the purposes of this Agreement, as determined by the mutual agreement of the Parties.