Common use of JSC Responsibilities Clause in Contracts

JSC Responsibilities. The JSC shall be responsible for overseeing and managing the collaboration with respect to Cell Therapy Products and Collaboration Products, including, without limitation the following functions: (A) The JSC shall meet at least twice per Calendar Year. Such meetings shall alternate between Amgen and ViaCell locations and be held at such times as are agreed upon by the JSC. At least one JSC meeting per year shall be conducted in person, whereas other JSC meetings may be held in person or by video conference or teleconference. The first meeting shall be held at Amgen's facilities within [**] of the Effective Date, and the agenda for such meeting shall include a review of a program plan for 2004 including a budget for Direct Development Costs for CB001 and any other Cell Therapy Products. If a Party's representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meeting. In addition, each Party may, at its discretion (and with the consent of the other Party, not to be unreasonably withheld), invite additional employees, consultants or scientific advisors to attend any JSC meetings. (B) The JSC shall review and discuss the progress of ViaCell's Development and manufacturing of Cell Therapy Products and, if applicable, Amgen's Development and Commercialization and ViaCell's manufacturing of Collaboration Products, including review of plans, budgets, clinical trial designs, data, results and other information in appropriate detail to enable the JSC members to meaningfully monitor the progress of the Development, manufacturing and Commercialization efforts of the Parties and to provide advice and feedback relating thereto. (C) The JSC shall consider the applicability and usefulness of any Materials that a Third Party or Amgen may (in its sole discretion) choose to make available to ViaCell for use in producing or using the Cell Therapy Products and/or the Collaboration Products. (D) Each year at the first JSC Meeting after the beginning of ViaCell's fiscal year the JSC shall review an annual budget for projected Direct Development Costs for each Cell Therapy Product for the following year prepared by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC meeting after the end of ViaCell's fiscal year, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product to the budget previously reviewed. Upon approval by the JSC of the budget and the reconciliation, such approvals shall be noted in the minutes of the JSC meeting. [**]. (E) For Collaboration Products, each Party shall submit to the JSC for review prior to the end of [**] its [**] plans and budgets in draft form covering activities for which it is responsible. [**]. (F) The JSC shall perform such other functions as appropriate to further the purposes of the collaboration pursuant to the terms and conditions of this Agreement. [**] Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed with the Commission. The JSC shall not have the authority to require Amgen or ViaCell to undertake or modify any activities for which such Party is responsible under this Agreement. Further, notwithstanding the above responsibilities of the JSC, nothing in this Section 2.3 shall erode or detract from each Party's rights and responsibilities for Developing, manufacturing and Commercializing Cell Therapy Products and Collaboration Products pursuant to the Program Plan and as described in this Agreement.

JSC Responsibilities. The JSC shall be responsible for overseeing and managing have the collaboration following responsibilities with respect to Cell Therapy Products and Collaboration Products, including, without limitation the following functionsCollaboration: (Aa) The JSC reviewing reports and updates provided by Alnylam regarding the Development of Licensed Products under the Initial Development Plan, including material modifications and updates to the Initial Development Plan provided by Alnylam in accordance with Section 2.2.1, providing Alnylam with feedback regarding same and approving such updates and modifications to the Initial Development Plan in accordance with Section 2.2.1; (b) [***]; (c) approving Extra Early Development Costs in accordance with Section 2.3.1(c); (d) reviewing reports and updates provided by MedCo regarding the Development of Licensed Products in the Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with Section 2.2.3; (e) ensuring coordination between the Parties with respect to Development activities in the Territory for Licensed Products under the MedCo Development Plan (to the extent the Parties have agreed in writing that Alnylam should perform any such activities), and regulatory and pharmacovigilance requirements and matters to the extent necessary for the Parties to perform their duties or exercise their rights hereunder and for the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authorities, respectively; (f) regularly assessing the progress of Alnylam in its conduct of the Initial Development Plan and the progress of MedCo in its conduct of the MedCo Development Plan, against the respective timelines contained therein; (g) reviewing Alnylam Technology that would be reasonably helpful to MedCo’s Development of Licensed Products and determine which of such Alnylam Technology should be transferred to MedCo; and (h) performing such other activities as the Parties agree in writing shall meet at least twice per Calendar Year. Such meetings shall alternate between Amgen and ViaCell locations and be held at such times as are agreed upon by the responsibility of the JSC. At least one JSC meeting per year shall be conducted in person, whereas other JSC meetings may be held in person or by video conference or teleconference. The first meeting shall be held at Amgen's facilities within CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[**] *]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. For purposes of the Effective Date, and the agenda for such meeting shall include a review of a program plan for 2004 including a budget for Direct Development Costs for CB001 and any other Cell Therapy Products. If a Party's representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meeting. In addition, each Party may, at its discretion (and with the consent of the other Party, not to be unreasonably withheld), invite additional employees, consultants or scientific advisors to attend any JSC meetings. (B) The JSC shall review and discuss the progress of ViaCell's Development and manufacturing of Cell Therapy Products and, if applicable, Amgen's Development and Commercialization and ViaCell's manufacturing of Collaboration Products, including review of plans, budgets, clinical trial designs, data, results and other information in appropriate detail to enable the JSC members to meaningfully monitor the progress of the Development, manufacturing and Commercialization efforts of the Parties and to provide advice and feedback relating thereto. (C) The JSC shall consider the applicability and usefulness of any Materials that a Third Party or Amgen may (in its sole discretion) choose to make available to ViaCell for use in producing or using the Cell Therapy Products and/or the Collaboration Products. (D) Each year at the first JSC Meeting after the beginning of ViaCell's fiscal year the JSC shall review an annual budget for projected Direct Development Costs for each Cell Therapy Product for the following year prepared by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC meeting after the end of ViaCell's fiscal yearclarity, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product to the budget previously reviewed. Upon approval by the JSC of the budget and the reconciliation, such approvals shall be noted in the minutes of the JSC meeting. [**]. (E) For Collaboration Products, each Party shall submit to the JSC for review prior to the end of [**] its [**] plans and budgets in draft form covering activities for which it is responsible. [**]. (F) The JSC shall perform such other functions as appropriate to further the purposes of the collaboration pursuant to the terms and conditions of this Agreement. [**] Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed with the Commission. The JSC shall not have the authority to require Amgen or ViaCell to undertake or modify any activities for which such Party is responsible under this Agreement. Further, notwithstanding the above responsibilities terms of the JSC, nothing in this Section 2.3 shall erode or detract from each Party's rights and responsibilities for Developing, manufacturing and Commercializing Cell Therapy Products and Collaboration Products pursuant to the Program Plan and as described in this Agreement.

JSC Responsibilities. The JSC shall be responsible for overseeing and managing have the collaboration following responsibilities with respect to Cell Therapy Products and Collaboration Products, including, without limitation the following functions: (A) The JSC shall meet at least twice per Calendar Year. Such meetings shall alternate between Amgen and ViaCell locations and be held at such times as are agreed upon by the JSC. At least one JSC meeting per year shall be conducted in person, whereas other JSC meetings may be held in person or by video conference or teleconference. The first meeting shall be held at Amgen's facilities within [**] of the Effective Date, and the agenda for such meeting shall include a review of a program plan for 2004 including a budget for Direct Development Costs for CB001 and any other Cell Therapy Products. If a Party's representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meeting. In addition, each Party may, at its discretion (and with the consent of the other Party, not to be unreasonably withheld), invite additional employees, consultants or scientific advisors to attend any JSC meetings. (B) The JSC shall review and discuss the progress of ViaCell's Development and manufacturing of Cell Therapy Products and, if applicable, Amgen's Development and Commercialization and ViaCell's manufacturing of Collaboration Products, including review of plans, budgets, clinical trial designs, data, results and other information in appropriate detail to enable the JSC members to meaningfully monitor the progress of the Development, manufacturing Manufacturing, having Manufactured and Commercialization efforts of the Parties Licensed Drug Candidates and to provide advice and feedback relating thereto. (C) The JSC shall consider the applicability and usefulness of any Materials that a Third Party or Amgen may (in its sole discretion) choose to make available to ViaCell for use in producing or using the Cell Therapy Products and/or the Collaboration Products. (D) Each year at the first JSC Meeting after the beginning of ViaCell's fiscal year the JSC shall review an annual budget for projected Direct Development Costs for each Cell Therapy Product for the following year prepared by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC meeting after the end of ViaCell's fiscal year, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product to the budget previously reviewed. Upon approval by the JSC of the budget and the reconciliation, such approvals shall be noted in the minutes of the JSC meeting. [**]. (E) For Collaboration Products, each Party shall submit to the JSC for review prior to the end of [**] its [**] plans and budgets in draft form covering activities for which it is responsible. [**]. (F) The JSC shall perform such other functions as appropriate to further the purposes of the collaboration pursuant to the terms and conditions of this Agreement. [**] Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed with the Commission. The JSC shall not have the authority to require Amgen or ViaCell to undertake or modify any activities for which such Party is responsible under this Agreement. Further, notwithstanding the above responsibilities of the JSC, nothing in this Section 2.3 shall erode or detract from each Party's rights and responsibilities for Developing, manufacturing and Commercializing Cell Therapy Products and Collaboration Licensed Products pursuant to the Program Collaboration: (a) review, discuss and approve the Global Development Plan including regulatory strategy and any updates or amendments thereto; (b) review and discuss each Ono Territory Development Plan, and all amendments and updates to such Ono Territory Development Plan; (c) review and discuss each Repare Territory Development Plan, and all amendments and updates to such Repare Territory Development Plan; (d) endeavor to ensure that each Party is appropriately advised as to Development being conducted by the other Party in its respective Territory; (e) report and monitor progress of Development activities and discuss any results thereunder; (f) review protocols for Clinical Studies for the Licensed Drug Candidate and Licensed Product, including combination therapy; (g) assist in coordinating scientific interactions and division of responsibilities, when applicable, with respect to Development activities; (h) review and approve Global Commercialization Strategy; (i) review and discuss Ono Territory Commercialization Plan and any updates or amendments thereto, and discuss any results thereunder; (j) review and approve Global Branding Strategy and any updates or amendments thereto, and discuss any results thereunder; (k) serve as described the forum for the settlement of disputes or disagreements, including whether or not either Party is making its Commercially Reasonable Efforts in relation to the Development or the Commercialization of Licensed Drug Candidates and Licensed Products; (l) review and approve a proposal from a Party to conduct preclinical and non-clinical studies with respect to Drug Candidates and Licensed Products in other Party’s Territory (which approval shall not be unreasonably withheld ); (m) review, discuss and approve each Global Clinical Study Proposal; (n) review and discuss each Party’s or its Related Party’s long term Development strategy in the respective Territory in a timely manner; (o) review, discuss and oversee the CMC and Manufacture of Licensed Drug Candidates and Licensed Products; (p) overseeing the JSC’s Working Group and ensuring effective participation in each such Working Group’s operations by any of its members; (q) reviewing the status of Licensed Drug Candidates and Licensed Products, including material Development and Commercialization matters; (r) addressing any other matters referred to the JSC by the terms of this Agreement; and (s) performing such other activities as the Parties agree in writing from time to time shall be the responsibility of the JSC. For the avoidance of doubt, decisions with respect to each of the above matters or any other matter that is identified in this Agreement as being subject to JSC approval, shall be subject to the processes set forth in Section 8.1.7 (Decision Making), including the escalation and tie-breaking provisions provided herein, except as otherwise expressly set forth in this Agreement.

JSC Responsibilities. The JSC shall have the following responsibilities: (a) reviewing, approving, monitoring and overseeing all Palatin Development Activities, including ensuring AMAG’s ability to review and comment on all materials, discussions and strategies related to, and to attend, as applicable, (i) clinical studies (including related protocols and final study reports) to be responsible conducted by Palatin pursuant to the Palatin Development Activities, (ii) any meetings or discussions with any Regulatory Authorities with respect thereto, including any pre-NDA meetings and (iii) interactions with scientific advisors and key opinion leaders with respect thereto; (b) establishing procedures for overseeing maintaining and managing recording the collaboration costs incurred in conducting the Palatin Development Activities, and establish and update as required approved budgets for Palatin Development Activities; (c) establishing procedures to allow AMAG to audit Palatin’s Third Party vendors with respect to Cell Therapy Products and Collaboration Products, including, without limitation the following functions:Palatin Development Activities; (Ad) The forming such other committees and sub-committees as the JSC shall meet at least twice per Calendar Year. Such meetings shall alternate between Amgen may deem appropriate, provided that such committees and ViaCell locations and be held at such times as are agreed upon by the JSC. At least one JSC meeting per year shall be conducted in person, whereas other JSC meetings sub-committees may be held in person or by video conference or teleconference. The first meeting shall be held at Amgen's facilities within CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…**] of the Effective Date*…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, and the agenda for such meeting shall include a review of a program plan for 2004 including a budget for Direct Development Costs for CB001 and any other Cell Therapy ProductsAS AMENDED. If a Party's representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meeting. In addition, each Party may, at its discretion (and with the consent of the other Party, not to be unreasonably withheld), invite additional employees, consultants or scientific advisors to attend any JSC meetings. (B) The JSC shall review and discuss the progress of ViaCell's Development and manufacturing of Cell Therapy Products and, if applicable, Amgen's Development and Commercialization and ViaCell's manufacturing of Collaboration Products, including review of plans, budgets, clinical trial designs, data, results and other information in appropriate detail to enable the JSC members to meaningfully monitor the progress of the Development, manufacturing and Commercialization efforts of the Parties and to provide advice and feedback relating thereto. (C) The JSC shall consider the applicability and usefulness of any Materials that a Third Party or Amgen may (in its sole discretion) choose to make available to ViaCell for use in producing or using the Cell Therapy Products and/or the Collaboration Products. (D) Each year at the first JSC Meeting after the beginning of ViaCell's fiscal year the JSC shall review an annual budget for projected Direct Development Costs for each Cell Therapy Product for the following year prepared by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC meeting after the end of ViaCell's fiscal year, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product to the budget previously reviewed. Upon approval by the JSC of the budget and the reconciliation, such approvals shall be noted in the minutes of the JSC meeting. [**]. (E) For Collaboration Products, each Party shall submit recommendations to the JSC for review prior to the end of [**] its [**] plans and budgets in draft form covering activities for which it is responsible. [**].but may not be delegated JSC decision-making authority; and (Fe) The JSC shall perform performing such other functions activities as appropriate to further the purposes of Parties agree in writing shall be the collaboration pursuant to the terms and conditions of this Agreement. [**] Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed with the Commission. The JSC shall not have the authority to require Amgen or ViaCell to undertake or modify any activities for which such Party is responsible under this Agreement. Further, notwithstanding the above responsibilities responsibility of the JSC, nothing in this Section 2.3 shall erode or detract from each Party's rights and responsibilities for Developing, manufacturing and Commercializing Cell Therapy Products and Collaboration Products pursuant to the Program Plan and as described in this Agreement.

JSC Responsibilities. The JSC shall will be responsible for: (a) overseeing the implementation of the Research Plan; (b) considering the results of Celera Validation; (c) considering the results of SGI Validation and selecting Collaboration Products from Designated Antibodies and ADC Products; (d) allocating responsibility for overseeing Research Plan activities between the Parties, taking into consideration their relevant expertise and managing available resources; (e) monitoring and reviewing the collaboration progress of the Research Plan and the results thereof; (f) recommending to the Parties any modifications to the Research Plan; *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to Cell Therapy Products the omitted portions. (g) facilitating an effective exchange of information between the Parties regarding the Research Plan and any Development and Commercialization Plan(s); (h) determining whether a Designated Antigen will be a source of Collaboration Products; (i) approving the Annual Budget; (j) evaluating the impact of Third Party Obligations on the development and Commercialization of any Collaboration Product and rejecting or accepting such Collaboration Product in view of such Third Party Obligations; (k) developing a [***]; (l) allocating responsibility for each [***]; (m) monitoring and reviewing the progress of the Development and Commercialization Plans and the results thereof; (n) recommending to the Parties any modifications to Development and Commercialization Plans; (o) approving the Collaboration Accounting Policies and any subsequent changes thereto; (p) approving termination of any Development and Commercialization Plan or abandonment of any Collaboration Product, and determining whether a particular Designated Antibody or ADC Product will not be a Collaboration Product; (q) overseeing the Commercialization activities of the Collaboration Program; (r) recommending the [***]; (s) reviewing for approval or rejection a request by a Party to grant a license to a Third Party under any Collaboration Technology or Collaboration Patent Rights; and (t) consistent with and subject to Article 9 and Article 10 of this Agreement, overseeing intellectual property matters arising under the Collaboration Program, including, without limitation limitation: (i) assigning responsibility for the following functions: preparation, filing, prosecution and maintenance of Joint Collaboration Patent Rights; (Aii) The JSC shall meet at least twice per Calendar Year. Such meetings shall alternate between Amgen reviewing all invention disclosures arising under or relating to the Collaboration Program for the purposes of making patent application filing recommendations to the Parties and ViaCell locations for determining proper inventorship and be held at ownership of such times inventions; (iii) establishing policies for the filing of foreign patent applications arising from the Collaboration Program; (iv) creating and approving, as are agreed upon by the JSC. At least one JSC meeting per year shall be conducted in personnecessary, whereas other JSC meetings may be held in person or by video conference or teleconference. The first meeting shall be held at Amgen's facilities within [**] of the Effective Date, and the agenda for such meeting shall include a review of a program plan for 2004 including a budget for Direct Development Costs for CB001 management of intellectual property related costs to be shared by the Parties pursuant to this Agreement; (v) determining which Collaboration Products should be marked with which Patent Right numbers; and (vi) addressing any other Cell Therapy Products. If a Party's representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meeting. In addition, each Party may, at its discretion (and with the consent of the other Party, not to be unreasonably withheld), invite additional employees, consultants or scientific advisors to attend any JSC meetings. (B) The JSC shall review and discuss the progress of ViaCell's Development and manufacturing of Cell Therapy Products and, if applicable, Amgen's Development and Commercialization and ViaCell's manufacturing of Collaboration Products, including review of plans, budgets, clinical trial designs, data, results and other information in appropriate detail to enable the JSC members to meaningfully monitor the progress of the Development, manufacturing and Commercialization efforts of the Parties and to provide advice and feedback relating thereto. (C) The JSC shall consider the applicability and usefulness of any Materials that a Third Party or Amgen may (in its sole discretion) choose to make available to ViaCell for use in producing or using the Cell Therapy Products and/or the Collaboration Products. (D) Each year at the first JSC Meeting after the beginning of ViaCell's fiscal year the JSC shall review an annual budget for projected Direct Development Costs for each Cell Therapy Product for the following year prepared by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC meeting after the end of ViaCell's fiscal year, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product to the budget previously reviewed. Upon approval by the JSC of the budget and the reconciliation, such approvals shall be noted in the minutes of the JSC meeting. [**]. (E) For Collaboration Products, each Party shall submit intellectual property issues referred to the JSC for review prior to the end of [**] its [**] plans and budgets in draft form covering activities for which it is responsible. [**]. (F) The JSC shall perform such other functions as appropriate to further the purposes of the collaboration pursuant to the terms and conditions of this Agreement. [**] Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed with the Commission. The JSC shall not have the authority to require Amgen or ViaCell to undertake or modify any activities for which such Party is responsible under this Agreement. Further, notwithstanding the above responsibilities of the JSC, nothing in this Section 2.3 shall erode or detract from each Party's rights and responsibilities for Developing, manufacturing and Commercializing Cell Therapy Products and Collaboration Products pursuant to the Program Plan and as described in this Agreement.

JSC Responsibilities. The JSC’s overall responsibility shall be to encourage and facilitate ongoing cooperation between the Parties with respect to the activities contemplated by this Agreement and to perform the other obligations specifically delegated to the JSC by this Agreement, subject to the limitations set forth in this Section 4.5(b). The JSC shall be responsible for overseeing also serve as the principal means by which GSK keeps Idenix informed regarding GSK’s development plans, efforts and managing the collaboration results with respect to Cell Therapy Products and Collaboration Products, including, without limitation the following functions:as required under this Agreement. (Ai) The Decisions of the JSC shall meet be made by unanimous vote, with each Party’s representatives on the JSC collectively having one (1) vote. No vote of the JSC may be taken unless at least twice per Calendar Year. Such meetings shall alternate between Amgen and ViaCell locations and be held at such times as are agreed upon by the JSC. At least one JSC meeting per year shall be conducted in person, whereas other JSC meetings may be held in person or by video conference or teleconference. The first meeting shall be held at Amgen's facilities within [**] of each Party’s representatives is present for the Effective DateJSC vote. Notwithstanding the foregoing, the Parties agree to the following limitations with respect to the authority of the JSC: (ii) The JSC’s role with respect to Products shall be solely informational and advisory, and the agenda for JSC shall not have any decision-making authority, or any power to direct GSK’s Development efforts or amend this Agreement. If, GSK determines in good faith that material changes to the Development Plan are advisable, GSK shall promptly inform Idenix thereof and, at Idenix’s written request, the Parties shall promptly convene a JSC meeting to discuss the nature of such meeting shall include a review of a program plan for 2004 including a budget for Direct Development Costs for CB001 changes and any other Cell Therapy Products. If a Party's representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meetingthe rationale therefor. In addition, each Party mayif GSK determines, that a material delay in the performance of the Development Plan is reasonably likely, GSK shall promptly inform Idenix thereof and, at its discretion (Idenix’s written request, the Parties shall promptly convene a JSC meeting to discuss the cause(s) of such delay, the estimated duration of the delay and with the possibility of avoiding or mitigating such delay. Notwithstanding the foregoing GSK may not, without the prior written consent of the other PartyIdenix, not to be unreasonably withheld), invite additional employeesmake a change to the Development Plan that would remove or significantly delay any Development milestone provided in Section 5.2(a) below, consultants or scientific advisors to attend not including any JSC meetings. (B) The JSC shall review and discuss delays caused by Regulatory Authorities. However, in the progress event of ViaCell's a fundamental difference of opinion between the Parties regarding the Development and manufacturing of Cell Therapy Products and, if applicable, Amgen's Development and Commercialization and ViaCell's manufacturing of Collaboration path for Products, including review of plans, budgets, clinical trial designs, data, results and other information in appropriate detail Idenix or GSK shall have the right to enable the JSC members to meaningfully monitor the progress of the Development, manufacturing and Commercialization efforts of the Parties and to provide advice and feedback relating thereto. (C) The JSC shall consider the applicability and usefulness of any Materials that a Third Party or Amgen may (in its sole discretion) choose to make available to ViaCell for use in producing or using the Cell Therapy Products and/or the Collaboration Products. (D) Each year at the first JSC Meeting after the beginning of ViaCell's fiscal year the JSC shall review an annual budget for projected Direct Development Costs for each Cell Therapy Product for the following year prepared by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC meeting after the end of ViaCell's fiscal year, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product refer such matter to the budget previously reviewed. Upon approval by the JSC Chief Executive Officer of the budget Idenix and the reconciliationSVP Medicines Development Center, such approvals shall be noted in the minutes of the JSC meeting. [**]. (E) For Collaboration Products, each Party shall submit to the JSC Infectious Diseases at GSK for review prior to the end further discussion for a period of [**] its [**] plans (unless extended by mutual agreement of such officers). Such officers shall discuss such matter in good faith and budgets in draft form covering activities for which it is responsibleattempt to reach resolution. [**]. (F) The JSC In the event the Parties still cannot agree on a matter after such escalation to such officers, GSK shall perform have the ultimate decision-making authority with respect to any such other functions as appropriate to further the purposes of the collaboration pursuant Development matter subject to the terms and conditions limitations on such authority provided in Section 14.8(a). For the avoidance of this Agreement. [**] Portions of this exhibit doubt, GSK shall have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed with the Commission. The JSC shall not have the sole authority to require Amgen or ViaCell to undertake or modify any activities for which such Party is responsible under this Agreement. Further, notwithstanding manufacture the above responsibilities of the JSC, nothing in this Section 2.3 shall erode or detract from each Party's rights and responsibilities for Developing, manufacturing and Commercializing Cell Therapy Products and Collaboration Products pursuant to the Program Plan and as described in this AgreementProducts.