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 [***] ([***]) [***] 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 high-level, strategic oversight and discussion of the Parties’ activities, in particular with respect to the Development and co-promotion of Products for and in the U.S. and, to the extent related to Development of Products for the U.S., Development of Products for that part of the EU subject to the jurisdiction of EMA (it being understood that such Development for the EU is anticipated to be closely tied to Development for the U.S.). For that purpose and to the extent reasonably necessary, the JSC will:
(i) coordinate the activities of the Parties under this Agreement, including facilitating communications and discussion between the Parties with respect to the research under the Research Program, Development of Products for the U.S. and EU, and Commercialization of Products for the U.S. if ITI exercises a Co-Promotion Option under Section 6.4;
(ii) review, discuss and approve the Development Plan and any proposed amendments or revisions to such plan;
(iii) review and fully discuss the research of Back-Up Compounds, the Development of Products for the U.S. and EU, and the Commercialization of Products in such regions, and any other ongoing activities;
(iv) select Back-Up Compounds for further Development; Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(v) coordinate the Product manufacturing and supply activities of the Parties, including the transition of manufacturing responsibilities from ITI to Takeda pursuant to Section 7.4;
(vi) review and discuss the draft Commercialization Plan for each Co-Promotion Product;
(vii) review, discuss and coordinate the Commercialization activities of ITI and Takeda with respect to Co-Promotion Products, including pre-launch and post-launch activities and any co-promotion activities by the Parties;
(viii) resolve disputes arising from the JRC or JPC; 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 Pa...
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 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. 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 have established a joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) for the coordination and oversight of certain of the Parties’ activities under this Agreement. The role of the JMC shall be to:
(i) coordinate forecasting, ordering and other supply-related logistics;
(ii) discuss supply-related issues, including shortfalls and quality issues;
(iii) no later than six months prior to the First Commercial Sale in any country in the Licensed Territory, devise, agree upon and begin implementing a strategy for requirements of safety supplies of necessary Raw Materials and/or other materials to be utilized in the manufacture of Bulk Product, which strategy will be reviewed on an annual basis;
(iv) discuss supply-related issues regarding other forms of drug substance or finished product (if any) being pursued jointly by Allos and MMCO or by MMCO independently;
(v) discuss and coordinate manufacturing-related complaints, recalls and any other supply related issues;
(vi) review and discuss proposals to engage, qualify and maintain Third Party Contractors;
(vii) discuss the content and scope of any quality audit undertaken, or to be undertaken, by Allos as it relates to its Third Party manufacturers;
(viii) review and agree on Allos’ budget amounts (including agreeing on the applicable FTE rates) for performing the technical assistance contemplated under Section 3.14;
(ix) discuss whether Allos can meet the combined MMCO and Allos requirements for Bulk Product (including by increasing batch sizes and/or capacity or through additional sources) when (A) MMCO’s rolling good faith forecast for required quantities of Bulk Product for the Licensed Territory together with Allos’ rolling good faith forecast for required quantities of Bulk Product for the Allos Territory equals or exceeds, in the aggregate, three batches (when converted to batch quantities and based on [***] then current batch size) for a four Calendar Quarter period, as contemplated under Section 3.3(c); or (B) MMCO’s rolling good faith forecast for required quantities of Bulk Product for the Licensed Territory together with Allos’ good faith rolling forecast for required quantities of Bulk Product for the Allos Territory equals or exceeds, in the aggregate, two batches (when converted to batch quantities and based on [***] then current batch size) for any Calendar Quarter, as contemplated under Section 3.3(c); and
(x) perform such other functions as may be appropriat...
Formation and Role. Within [*] after the Effective Date, the Parties shall establish a joint commercialization committee (the "Joint Commercialization Committee" or "JCC") that will be responsible for overseeing the Commercialization of the Product in the Field in the Licensed Territory. The role of the JCC shall be:
(i) to discuss the Parties' respective Commercialization activities in and as between the Licensed Territory and the Allos Territory;
(ii) to review and comment upon the Commercialization Plan submitted by Mundipharma, as well as any amendments thereto submitted by Mundipharma, and to submit such Commercialization Plan or amendment thereto to the JSC for review and discussion;
(iii) to oversee implementation of the Commercialization Plan;
(iv) to review and discuss overall strategy for Pricing Approval and Reimbursement Approval of the 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 the Product is being discussed; and
(vi) to perform such other functions as appropriate to further the purposes of this Agreement with respect to the Commercialization of the Product, as directed by the JSC.
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.
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.
