Formation and Role. The Parties hereby establish a Joint Committee that shall monitor and coordinate communication regarding the Parties' performance under this Agreement to Develop and obtain Regulatory Approval for the Product in the Field and in the Licensed Territory. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2. The role of the Joint Committee shall be:
(i) to review the overall strategy for seeking Regulatory Approval in the Licensed Territory of the Product for the Initial Indications and any other indications in the Field Collaborator seeks to develop the Product for;
(ii) to facilitate the exchange of information between the Parties with respect to the activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for Collaborator's Development of Products hereunder, consistent with this Agreement;
(iii) to review, approve, and, if necessary, amend the Development Plan;
(iv) to seek to resolve any issues arising under this Agreement;
(v) to monitor the Parties' performance against each then-current Development Plan;
(vi) to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products in the Licensed Territory; and
(vii) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this Agreement.
Formation and Role. Within [* * *] days after the Effective Date, the Parties shall appoint a joint steering committee (the “Joint Steering Committee” or “JSC”) to coordinate and oversee the Parties’ activities under this Agreement through the completion of Development Transition. Following the Development Transition, the JSC shall serve solely in an advisory and information-sharing capacity, and the JSC shall disband upon the first Regulatory Approval of a Licensed Product anywhere in the Territory. The role of the JSC shall be to manage, review and discuss Virobay’s activities with respect to the Development and Manufacture of Licensed Products and the transfer of Development responsibilities from Virobay to XXX. For that purpose and to the extent reasonably necessary, the JSC will:
(i) coordinate the activities of the Parties under the Development Plan, including facilitating communications and discussions between the Parties with respect to the Development of Compounds and Licensed Products under the Development Plan;
(ii) review, discuss and approve any proposed amendments or revisions to the Development Plan;
(iii) discuss and oversee Virobay’s negotiations and relationships with Third Party manufacturers of Compounds and Licensed Products;
(iv) oversee the transfer of Development responsibility and Information from Virobay to XXX;
(v) coordinate the Licensed Product Manufacturing and supply activities of the Parties, including the transfer of Manufacturing Information and transition of Manufacturing responsibilities from Virobay to XXX pursuant to Section 7.4;
(vi) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Compounds and Licensed Products;
(vii) review and facilitate discussion of any requests in relation to publications pursuant to Section 12.3;
(viii) confirm completion of Development Transition; and
(ix) 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. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and shall have no power (A) to amend, modify, or waive compliance with this Agreement; (B) to determine whether or not a breach of this Agreement has occurred; or (C) to otherwise interpret this Agreement.
Formation and Role. 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:
(i) to review, discuss and approve the overall strategy for the Development and Drug Approval of the Product in the Field in the Licensed Territory;
(ii) to review and discuss the overall performance of the Parties pursuant to this Agreement and to compare such performance to the objectives outlined in the Development Plan and to the diligence obligations set forth in Section 4.6;
(iii) to review, discuss and approve any amendments to the Development Plan proposed by the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective Date);
(iv) to review and discuss the Commercialization Plan and any amendments to the Commercialization Plan proposed by the JCC;
(v) to review and discuss overall strategy for Pricing Approval and Reimbursement Approval of the Product in the Field in the Licensed Territory;
(vi) to discuss the Parties' activities with respect to the Product in the Field in the Licensed Territory in conjunction with Allos' and its licensees' activities with respect to the Product in the Field in the Allos Territory;
(vii) to review any [*] after receipt of Regulatory Approval;
(viii) to direct and oversee the JDC, JCC, JMC and any other operating committee (the "Other Committees") established by the JSC, on all significant issues that fall within the purview of such committees;
(ix) to appoint Other Committees, consisting of equal numbers of appropriately qualified members appointed by each Party, from time to time as it deems fit;
(x) to attempt to resolve, in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC and Other Committees; and
(xi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement. The JSC shall have no power to interpret, amend, modify, or waive compliance with this Agreement.
Formation and Role. The Parties hereby establish a Joint Steering Committee that shall monitor and coordinate communication regarding the Parties' performance under this Agreement to Develop, obtain Regulatory Approval for and Commercialize the Product in the Field. The role of the JSC shall be:
(i) to review the overall strategy for Developing and seeking Regulatory Approval for, manufacturing, and Commercializing the Product in the Licensed Territory and in the Field;
(ii) to facilitate the exchange of information between the Parties with respect to the activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for each Party's Development and Commercialization of the Product hereunder, consistent with this Agreement;
(iii) to review, approve, and, if necessary, amend the U.S. Development Plan, the Development Budget and the U.S. Commercialization Plan (including related budget);
(iv) to review the plan and the summary budget for the ROW Development to the extent customarily generated by or available to Takeda from its Affiliates or sublicensees for its internal purposes with respect to the applicable countries in the Royalty Territory (all Xxxxx 0 Xxxxxxx xxx Xxxxx 0 Xxxxxxx wherein Takeda decides to Develop the Product, as described in further detail in Section 3.5) and the ROW Commercialization Plan and provide comments regarding the content and implementation of such plans, which comments shall not be controlling but shall be considered by Takeda in good faith;
(v) to monitor the Parties' performance against the then-current U.S. Development Plan and Commercialization Plans;
(vi) to create subcommittees as the JSC may find necessary or desirable from time to time for implementation of the Development and Commercialization hereunder;
(vii) to oversee the activities of subcommittees created under this Agreement, and to seek to resolve any issues that such subcommittees cannot resolve;
(viii) without reducing Affymax's obligation to obtain and maintain the Affymax Patents and/or the Product Trademark provided for herein, to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for the Product in the Licensed Territory; and
(ix) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties.
Formation and Role. Within [***] days after the Effective Date, the Parties shall establish a Joint Steering Committee (the “Joint Steering Committee” or “JSC”) to facilitate the exchange of information relating to each Party’s Development and Commercialization activities with respect to the Compound and/or Products. The JSC shall provide a forum for each Party to apprise the other and, to the extent applicable, coordinate, strategies and timelines for the Development, Regulatory Approval and Commercialization of Product in the Territory. Decisions of the JSC, as brought to a vote by the chairperson(s), shall be made [***]. The JSC shall not have the power to bind either of the Parties or to make any tactical or day-to-day operational decisions with respect to either Party’s activities under this Agreement or otherwise. The JSC may establish and may separately dissolve sub-committees (with equal representation from both Parties) for detailed or technical discussions.
Formation and Role. The Parties shall, as soon as practicable but not later than within ninety (90) days after the Effective Date, form a joint advisory committee (the “Joint Advisory Committee” or “JAC”). The JAC will provide a forum for the good faith discussion of major matters related to this Agreement, including in particular (but not limited to) matters of commercial performance, supply, overall performance, capital investment and business planning (strategy and management), and the transition to Customer-Supplied Materials arrangements contemplated by Section 12.1(f), but also any other items, matters or activities, including with respect to any Facility.
Formation and Role. At least [***] before the anticipated launch of Product in the Field in [***], whichever shall occur first, the Parties shall establish a joint commercialization committee (the “JCC”) that will oversee the Commercialization of Product in the Field in the Licensed Territory. The role of the JCC is:
(i) to discuss the Parties’ respective Commercialization activities in and as between the Licensed Territory and the Licensor Territory;
(ii) to review and comment upon the Commercialization Plan submitted by Licensee, as well as any amendments thereto submitted by Licensee, and to submit such Commercialization Plan or amendment thereto to the JSC for review and discussion;
(iii) to monitor implementation of the Commercialization Plan;
(iv) to review and discuss overall strategy for Pricing Approval and Reimbursement Approval of Product in the Field in the Licensed Territory;
(v) to review, discuss and coordinate the Parties’ attendance, Product messaging and presentations (including “poster-board” presentations and industry booths) at international seminars and conferences at which Product is being discussed, if any; and
(vi) to perform such other functions as appropriate to further the purposes of this Agreement with respect to the Commercialization of Product, as directed by the JSC.
Formation and Role. Promptly, and in any event within [**] days after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to coordinate, oversee, review and discuss the Parties’ activities with respect to the Development of Licensed Products hereunder. For that purpose and to the extent reasonably necessary, the JSC will:
(i) coordinate the activities of the Parties under the Development Plan, including facilitating communications and discussions between the Parties with respect to the Development of Licensed Products under the Development Plan;
(ii) review, discuss and approve any proposed amendments or revisions to the Development Plan;
(iii) oversee technology transfer from Concert to Jazz;
(iv) establish the criteria for Successful Completion of a Phase 1 Clinical Trial and Phase 2 PoC Clinical Trial pursuant to Section 4.4(a);
(v) determine whether the criteria for Successful Completion have been satisfied pursuant to Section 4.4(b);
(vi) establish such Working Groups as it deems necessary to achieve the objectives and intent of this Agreement; and
(vii) 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. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and shall have no power to amend, modify, or waive compliance with this Agreement.
Formation and Role. Within thirty (30) days after the Effective Date or such further period of time as the Parties may agree, the Parties shall establish the JSC. The role of the JSC shall be:
(i) to discuss and coordinate regarding the overall strategy for conducting Development of and seeking Regulatory Approval for and Commercializing Licensed Products in the Territory by each Party in its respective field;
(ii) to review, discuss and approve any proposed amendments or revisions to the Sanofi Development Plan and KaloBios Development Plan;
(iii) to establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement and monitor the activities and performance of such subcommittees;
(iv) to coordinate the Parties’ efforts with respect to the manufacture of Licensed Product in accordance with Article 7 for the KaloBios Field and the Sanofi Field;
(v) to review and approve publication plans; and
(vi) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties in writing (subject to Section 3.2(e)). [***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND SEPARATELY FILED WITH THE COMMISSION.
Formation and Role. Within thirty (30) days after the Effective Date, the Parties shall establish a Joint Steering Committee (the “Joint Steering Committee” or “JSC”) to oversee the Development and Commercialization of the Licensed Product under this Agreement. The JSC shall not have any power to bind either Party or to make any tactical or day-to-day operational decisions with respect to either Party’s activities under this Agreement.
