Manufacturing Subcommittee Sample Clauses

Manufacturing Subcommittee. (a) The MSC shall consist of members from each of Eyetech and Pfizer, each of which shall confirm to the other its designees. The MSC shall be responsible for: (i) Overseeing manufacturing activities underway as of the Effective Date, including formulation development, product characterization studies, stability studies, and management of clinical supplies of the Products; (ii) Overseeing the manufacturing of registration batches of Product; (iii) Overseeing process development plans; (iv) Monitoring worldwide quality assurance efforts and ensuring that all Products are manufactured in accordance with the Parties' quality standards; (v) Overseeing supply relationships with any third party manufacturers; (vi) Subject to Section 4.1(c), review of the CMC section of the NDA for each Product, provided that the time period for reviewing any such CMC section shall, notwithstanding the provisions of Section 4.1(c), be thirty (30) days from the date on which Eyetech, through the CDRSC, provides Pfizer with a draft of the NDA pursuant to Section 4.1(c); (vii) Overseeing manufacture of the Products; (viii) Reviewing and approving Specifications for purposes of the NDA and for Launch; (ix) Commencing and overseeing any new manufacturing activities, including Product manufacturing process validation prior to NDA approval and any pre-approval inspection of the Product manufacturing subcontractors; (x) Coordinating with the CSC and CDRSC as appropriate; (xi) Preparation for FDA inspections and ensuring adherence to compliance standards; (xii) Evaluating the forecasts provided in each Marketing Plan as well as inventory levels for the Product and future logistic strategies and capacity planning; (xiii) Reviewing quality-related issues concerning the Product or any component thereof; and (xiv) Providing updates on the MSC's activities and achievements to the JOC. (b) If the MSC is unable to reach a decision on any issue within fifteen (15) Business Days after presentation, either Party may refer the issue to the JOC for resolution. Following a referral to the Senior Executives of the Parties pursuant to Section 3.7 below, [**]shall have final decision-making authority with respect to [**]; provided that: (i) Pfizer shall [**] any agreement [**] entered into [**] (ii) [**] Pfizer [**] and/or [**] that otherwise would [**], and Pfizer [**] pursuant to this Section 3.5 [**],
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Manufacturing Subcommittee. Within [**] days after the Effective Date, the Parties will establish a Subcommittee under the JDC for Manufacturing (including CMC) related matters, which shall initially be with respect to DOT1L (and thereafter, with respect to each Selected Target at the time a Compound Directed to such Selected Target meets the Development Candidate Selection Criteria pursuant to Section 2.2.5) (the “Manufacturing Subcommittee”). Notwithstanding anything to the contrary in this Agreement, on a Licensed Compound-by-Licensed Compound basis, (i) prior to Achievement of Proof of Concept, EPIZYME shall have final decision-making authority with respect to all Manufacturing matters in such CMC Subcommittee and (ii) after Achievement of Proof of Concept, [**] shall have final decision-making authority with respect to all such matters; provided that, nothing in this Section 4.4.3(a) shall [**]. Prior to Achievement of Proof of Concept with respect to the applicable Licensed Compound, in the event CELGENE desires to use or transfer to a Third Party any Manufacturing process selected by EPIZYME on behalf of the Collaboration in connection with an applicable Licensed Compound, Licensed Product or related Diagnostic Product and EPIZYME does not desire to move the related Manufacturing activities, upon CELGENE’s written request, EPIZYME shall provide a technology transfer of the relevant Know-How to a Third Party designated by CELGENE, at CELGENE’s cost and expense, in order to enable CELGENE to establish an alternative Manufacturing capability.
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Manufacturing Subcommittee. (a) In accordance with the Settlement and Termination Agreement, the OUSOC shall establish a manufacturing subcommittee (the “Manufacturing Subcommittee”), which shall (i) coordinate and oversee supply chain activities for the Products and (ii) serve as a forum for communication with respect to any supply chain issues and the Manufacturing Transition Activities relating to the Products. The Manufacturing Subcommittee shall meet as frequently as reasonably necessary to perform their obligations as described herein. (b) In the event that the Parties, through the Manufacturing Subcommittee, are unable to resolve any dispute in connection with this Agreement, the Manufacturing Subcommittee shall refer such dispute to the OUSOC for decision pursuant to Section 8.2(c)(v) of the Settlement and Termination Agreement, provided that all quality related disputes shall first be submitted to the QLT and/or the QWT, as applicable, in accordance with Section 2.3. If the OUSOC is unable to resolve such dispute, the OUSOC shall refer such dispute to the ESC for decision pursuant to Sections 8.2(a)(iv) and (v) of the Settlement and Termination Agreement.
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Manufacturing Subcommittee. 2.5.1 Within [***] calendar days following the Effective Date, each Party shall appoint [***] representative as its chair-person for the manufacturing and may appoint additional non-voting representatives (the “Manufacturing Subcommittee” or “MSC”) and give notice of the name and contact information of its respective subcommittee representative(s) to the other Party. 2.5.2 The MSC shall be responsible for the review and discussion of the manufacturing of the Product including any [***], as well as oversight of the execution of the Supply Agreement in line with Elanco’s manufacturing standards. Decisions of the MSC shall be made by consensus, provided that in the event that the Parties cannot agree on any matter relating to the manufacture of Product prior to the earlier of (a) [***], or (b) transfer of responsibility for manufacture of Product to Elanco pursuant to Article 8, [***] shall have the right to make the [***] decision on any matter relating to the manufacture of Product, unless [***] requests the [***] of the matter [***]. 2.5.3 The MSC shall terminate once the [***] has been [***], unless the Parties agree in writing to extend the duration of the MSC.
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Manufacturing Subcommittee. Promptly after the Amgen Option Effective Date, the Parties shall establish a manufacturing subcommittee to manage, oversee, facilitate and coordinate the transfer of manufacturing information and protocols by, and transition manufacturing from, CK to Amgen. Each Party will have representation on the Manufacturing Subcommittee throughout the Development Program, and the Manufacturing Subcommittee shall be subordinate to and governed by the JDC.
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Related to Manufacturing Subcommittee

  • Project Steering Committee 1. For a sound implementation and management of the project, a steering committee shall be set up in line with provisions of the programme manual. 2. The steering committee is the decision-making body of the project and it shall be composed by representatives of the LP and all PPs duly authorised to represent the respective LP and PP institutions. It shall be chaired by the LP and it shall meet on a regular basis. Associated partners shall be invited to take part in the steering committee in an advisory capacity. External key stakeholders may also be invited to take part to one or more meetings in an observer/advisory capacity. 3. The steering committee shall at least: a. be responsible for monitoring and validating the implementation of the project and the achievement of the planned results as in the approved application form; b. perform the financial monitoring of the project implementation and to decide on any budget modifications as in § 11 of this agreement; c. monitor and manage deviations of the project implementation; d. decide on project modifications (e.g. partnership, budget, activities, and duration) if needed; e. be responsible for the settlement of any disputes within the partnership (as stipulated in § 22 of this agreement). 4. Further aspects, including the creation of sub-groups or task forces, may be set out in the rules of procedure of the steering committee.

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular: (a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any; (f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product; (g) discuss Product list price and status of reimbursement in the Collaborator Territory; and (h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.

  • Steering Committee A. CIFNAL/ICBFN shall be managed by a Steering Committee comprised of elected representatives from the membership. B. The Steering Committee is empowered to conduct the business of CIFNAL/ICBFN in accordance with the recommendations of the membership; approve and enact project activities; discuss and recommend future policy or changes in policy to be adopted by the membership; make budgetary decisions for CIFNAL/ICBFN; approach funding agencies; conduct periodic membership drives; and maintain communication with scholarly and professional associations as well as with other, similar cooperative projects. C. The Steering Committee shall consist of at least five representatives of CIFNAL/ICBFN. 1. Four representatives shall be elected to at-large positions on the Steering Committee in accordance with the procedures in Section VIII. At least one representative shall be from a French or francophone institution. 2. The Chair of CIFNAL/ICBFN shall chair the Steering Committee. 3. Elected Coordinators of standing Working Groups shall serve on the Steering Committee for the period of their elected terms. 4. A representative of CRL shall serve as an ex officio member of the Steering Committee. D. An advisory group of scholars and end-users, including representatives from academic organizations concerned with library and scholarly issues in francophone studies as well as non-academic information users and providers, shall be appointed by the Steering Committee as appropriate. The makeup of the advisory group shall be formulated to provide a balance of opinion and diversity of expertise. Members of the advisory group need not be from institutions that are a member of CIFNAL/ICBFN, and shall serve as ex officio members of the Steering Committee. E. All elected representatives on the Steering Committee, including the Chair, shall have equal votes on matters requiring a formal approval by the Committee. Each member shall be accorded one vote. Ex officio members shall be non-voting members. F. Steering Committee Members shall serve three-year terms, with staggered elections; re- election is permitted for one additional term. Elected members begin their term of office immediately following the annual membership meeting. G. In the event a member is unable to serve a full term, the Chair shall appoint a replacement to serve the remainder of the term. Following this period, the replacement shall be eligible to stand for election according to the terms of Section V.

  • Development Committee Arcadia and Xxxxxx shall establish a development committee (the “Development Committee”) comprised of no more than three (3) representatives of each of Arcadia and Xxxxxx. The Development Committee shall be chaired by a member thereof designated from time to time by Arcadia. The Development Committee shall oversee the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions of the Development Committee shall be made by a written consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forth, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of Xxxx Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement shall be submitted for ADR as provided in Section 12(a).

  • Joint Steering Committee Promptly after the Effective Date, the Parties will form a Joint Steering Committee (the “JSC”) composed of an equal number of employees of each of Curis and Genentech, but in no event to exceed four (4) members from each Party. The JSC shall determine the specific goals for the Collaboration, shall manage the ongoing research conducted under the Collaboration in accordance with the Research Plan, shall monitor the progress and results of such work, and shall oversee and coordinate the development and commercialization of Compounds (other than Collaboration Products); provided, however, that the JSC shall not have decision-making authority with respect to the development and commercialization of Collaboration Products, which shall be governed by the CSC. The presence of at least one (1) representative of each Party shall constitute a quorum for the conduct of any JSC meeting. All decisions of the JSC shall require unanimous approval, with the representatives of each Party collectively having one (1) vote, provided in the event of a deadlock, the issue shall be referred to the Chief Executive Officer of Curis and the Senior Vice President of Research of Genentech, or their respective designees, who shall promptly meet and attempt in good faith to resolve such issue within thirty (30) days. If such executives cannot resolve such matter, then Genentech shall have final decision-making authority with regard to decisions regarding the Collaboration (including, without limitation, the JSC’s designation of a Compound as either a Lead Product or Excluded Product); provided, however, that in no event shall Genentech have the right or power to take any of the following actions without the approval of Curis’ representatives on the JSC: (a) approve the initial Research Plan (an outline of which has been agreed upon by the Parties as of the Effective Date); (b) amend or modify this Agreement or the Research Plan; (c) resolve any such matter in a manner that conflicts with the provisions of this Agreement (including, without limitation, the Research Plan); (d) make any decision with respect to the development or commercialization of Curis Products; or (e) make any decision with respect to the prosecution, maintenance, defense or enforcement of any Curis Patents. The JSC shall meet at such frequency as the JSC agrees, except that, until the filing of the first IND for a Lead Product utilizing Systemic Delivery in a Major Market, the JSC shall meet on at least a quarterly basis. Meetings of the JSC, and JSC dispute resolution meetings between Curis’ Chief Executive Officer and Genentech’s Senior Vice President of Research (or their designees), may be conducted by videoconference, teleconference or in person, as agreed by the Parties, and the Parties shall agree upon the time and place of meetings. A reasonable number of additional representatives of a Party may attend meetings of the JSC in a non-voting capacity. The JSC shall exist for so long as either any work is being conducted under the Research Plan or any Compound is being developed or commercialized by Genentech, Curis, or any of their respective Affiliate(s) or sublicensee(s) in any Major Market. The JSC shall also be responsible for designating one or more representatives of each Party with expertise in patent law (which individuals need not be members of the JSC) to oversee intellectual property matters relating to the Collaboration, subject to the provisions of Article 10, and such patent committee shall coordinate with and report to the JSC.

  • The Joint Committee (a) shall be composed of representatives of the Governments of the Parties; and (b) may establish and delegate its responsibilities to Sub-Committees.

  • Training Committee The parties to this Agreement may form a Training Committee. The Training Committee will be constituted by equal numbers of Employer nominees and ETU employee representatives and have a charter which clearly states its role and responsibilities. It shall monitor the clauses of this Agreement which relate to training and ensure all employees have equal access to training.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

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