Responsibilities of the Joint Steering Committee Sample Clauses

Responsibilities of the Joint Steering Committee. The JSC shall be responsible for reviewing and providing input on and, if expressly specified in this Agreement, approving the overall strategy of the Parties under this Agreement, including development plans and strategies, and for reviewing the Commercialization Program. Specifically, the JSC shall perform the following functions: 3.2.1 recommend a date not to be more than three (3) months from the Effective Date, to transfer to Egalet (i) pharmacovigilance reporting and related activities, including preparation and submission of 15-day reports and preparation of periodic adverse drug event reports (PADER); and (ii) Medical Affairs; 3.2.2 review, at least annually, the Commercialization Program, the Marketing Plan, Manufacturing operations, DEA Quotas, Product development plans and the Product sales forecast (including projected royalties payable to Acura) for the collaboration; 3.2.3 review all material Product development, marketing, Manufacturing (including Product inventory levels and requirements) and regulatory activities, milestones and accomplishments and progress to forecast, in summary fashion on a Calendar Quarter basis and in a reasonably detailed manner on a semi-annual basis; 3.2.4 review the Launch Date for the Product in the United States; 3.2.5 if Acura exercises its Co-Promotion Right, review and approve target health care provider lists, as applicable, and data and reports relating to Product Details undertaken during the prior Calendar Quarter, including the relative priority of such Details; 3.2.6 determine and approve the allocation of overlapping target healthcare providers pursuant to Section 5.3.13; 3.2.7 discuss strategies, plans and updates relating to pending or threatened Infringement Actions and Offensive Infringement Actions; 3.2.8 evaluate the progress of development of the Product in Other Countries and the timing of Launch in such Other Countries following receipt of Regulatory Approval in such Other Countries; 3.2.9 review and provide comment on the protocols and plans for the Required Post-Marketing Studies; 3.2.10 review and approve any Product Line Extension proposed to be conducted by Acura pursuant to Section 4.4.1; 3.2.11 review and approve (by unanimous consent of the JSC members) the proposed budget relating to each of the Product Line Extension Studies and the Required Post-Marketing Studies within ten (10) business days after submission of such proposed budget to the JSC, provided that neither Party shall with...
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Responsibilities of the Joint Steering Committee. The JSC shall be responsible for (a) planning and supervising research and development under this Agreement, including establishing, reviewing and recommending modifications and updates to the Research Plans; (b) receiving and reviewing all data and other information obtained by either Party in connection with the Research Program and monitoring and reporting to the Parties on activities conducted pursuant to the Research Plans; (c) documenting and approving initiation and completion of each Research Project and the achievement of any Technical Milestones, Development Milestones and Sales Milestones; (d) evaluating FTE requirements for the performance of the Research Plans; and (e) such other functions as expressly specified hereunder or as agreed by the Parties.
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Responsibilities of the Joint Steering Committee. The Joint Steering Committee shall be responsible for the supervision and overall execution of all Research Projects under the Research Program. In particular the Joint Steering Committee shall be responsible for (a) the preparation and approval of each Research Plan as developed by the JOT for each part or stage of the Research Program and any major change thereto; and (b) the oversight of timelines, costs (to be reported at every second JSC meeting or every six (6) months if the frequency of 2 JSC meetings exceeds six (6) months) and parties’ due diligence in carrying out their responsibilities; and (c) the establishment and updating of the then current Research Plan(s) to take into account current needs, and for making proposals for capacity allocations; and (d) the setting of priorities within the Research Project(s) and the Research Program; and (e) together with the JOT making written status reports on a regular basis for all Research Projects; and (f) the selection, approval and abandonment of additional Targets (each to be described in a separate Research Plan); (g) definition or the modification of CC Criteria and the selection of CC compounds to be submitted for approval to the RDC; and (h) the approval of resource allocations. The Joint Steering Committee shall not have the power to make any changes to the provisions of this Agreement.
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Responsibilities of the Joint Steering Committee. (a) In general, the responsibilities of the JSC will be to analyze, consult, review and advise MMT, solely on a non-binding, advisory basis, concerning the research, development, record keeping and other activities related to any Lead Drug, PDT Drug, PDT Device, PDT Therapy or the Pre-Clinical Development Program. As part of its responsibilities, the JSC will review and make non-binding recommendations as necessary from time to time concerning MMT's Pre-Clinical Development Program and Phase I Trial. Specific review and consulting activities for JSC include, but are not limited to, (i) recommending guidelines for staffing physician advisory groups, Pre-clinical Development Program Plans, and Phase I Trial plans, (ii) discussing project projections, budgets, tracking reports, and timelines, (iii) reviewing and discussing data from pre-clinical studies and clinical trials, (iv) recommending additional research studies beyond Pre-clinical Development Program Plans, (v) recommending timing of and content for the INDA submission program with respect to any Lead Drug, PDT Drug, PDT Device or PDT Therapy in the Therapeutic Field, (vi) recommending content for the clinical readiness review, (vii) analysis of the Phase I Trial Report, and (viii) recommending how to amend, as needed, the Pre-clinical Development Program and Phase I Trial plans. (b) The JSC shall have such other responsibilities as are expressly set forth elsewhere in this Agreement or as are assigned to it as mutually agreed upon by the Parties in writing.
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Responsibilities of the Joint Steering Committee. At each quarterly meeting of the JSC, the Parties, through their representatives on the JSC, shall be required to submit a report to the other members of the JSC on their respective activities for the prior calendar quarter setting forth their progress and specific activities undertaken in accordance with the Work Plan. In general, the JSC shall be responsible for reviewing and reporting on the progress of the Project, ensuring the Project proceeds according to the timelines set forth in the Work Plan, ensuring the cooperation and participation of the Parties in the performance of the Project and reviewing the recommendations, plans and other activities in support of the Project and coordinating the activities of the Parties under this Agreement to assure that the Project is aligned with the clinical development of the Product in the Territory. Subject to the other provisions of the Agreement, the JSC shall be responsible for coordinating the activities and decision-making of the Parties with respect to the approval of amendments to the Work Plan and all regulatory activities with respect to the Product as described further below. The following decisions shall require approval of the JSC (which approval shall not be unreasonably withheld or delayed): (a) the required level of sensitivity, specificity, scoring methodology, Results interpretation and performance criteria for the Product (including, for example, limits of quantitation, linearity, range, precision and accuracy); (b) the Labeling, including but not limited to the “Indication for Use” statement to be submitted in a Regulatory Submission or otherwise to be presented to a Regulatory Authority in the Licensed Territory for the Product; and (c) the type of Approval Application(s) to be developed and filed for Approval for the Product in the Licensed Territory.
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Responsibilities of the Joint Steering Committee. The Joint Steering Committee shall be responsible for directing, coordinating and supervising the research activities of the Parties during the Research Phase and the co-Development of Biontech Option Products, Sanofi Option Products and Sanofi Option Combination Products. In particular, the Joint Steering Committee shall (i) review and update the Research Plan; (ii) receive regular reports from each Party’s Alliance Manager on, and monitor the conduct, progress and results of each Party’s activities under the Research Plan; (iii) oversee and manage the work under, monitor the progress of, and implement any Development plan according to Section 4, including compliance with budget and timelines; (iv) review quarterly Manufacturing information produced in accordance with Section 3.3.6, including forecasts of clinical supplies requirements for the co-Development of Biontech Option Products, Sanofi Option Products and Sanofi Option Combination Products; (v) discuss and exchange information regarding the conduct of ongoing clinical trials; (vi) resolve any issues referred to it by the Parties in accordance with Section 13.7; and (vii) from time to time, establish one or more subcommittees or project teams to oversee particular projects or activities, as the JSC deems necessary or advisable. For the avoidance of doubt, the Joint Steering Committee shall not have any responsibilities with respect to Sanofi’s Development and Commercialization of Licensed Products.
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Responsibilities of the Joint Steering Committee. In addition to the responsibilities expressly described elsewhere in this Agreement, the JSC shall: (a) draft the R&D Plan and present it to the parties for approval; (b) monitor activities and execution of the R&D Plan; (c) develop updates or amendments to the R&D Plan including, but not limited to, the annual updates specified in Section 2.4, and recommend such updates or amendments to the parties for approval; (d) select compounds as candidates for clinical development (“IND Candidates”); (e) develop a plan related to the conduct of clinical trials and commercialization of Products developed under this Agreement; (f) attempt to settle disputes or disagreements that are unresolved by the Primary Contact Persons; and (g) perform any other activities related to the R&D Plan as may be requested by the parties from time to time. In no circumstance shall the JSC (i) have any authority to make any determination that either party is in breach of its obligations under the R&D Plan or this agreement; or (ii) have the authority to amend either this Agreement or the R&D Plan, other than the ability to recommend updates or amendments for approval by the parties.
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Related to Responsibilities of the Joint Steering Committee

  • Responsibilities of the Parties 1.5.1 The Parties shall perform all obligations of this Agreement in accordance with all Applicable Laws and Regulations, Operating Requirements, and

  • 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.

  • 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.

  • 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.

  • 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.

  • RESPONSIBILITIES OF THE OWNER The Owner agrees to: Provide all documentation, records, and disclosures as required by law or required by the Agent to manage and operate the Property, and immediately notify the Agent if the Owner becomes aware of any change in such documentation, records or disclosures, or any matter affecting the habitability of the Property; Indemnify, defend, and hold harmless the Agent, and all persons in the Agent's firm, regardless of responsibility, from all costs, expenses suits, liabilities, damages, attorneys fees, and claims of every type, including, but not limited to, those arising out of injury or death of any person, or damage to any real or personal property of any person, including the Owner, for: Any repairs performed by the Owner or by others hired directly by the Owner; or Those relating to the management, leasing, rental, security deposit, or operation of the Property by the Agent, or any person in the Agent's company, or the performance or exercise of any of the duties, powers, or authorities granted to the Agent; This sub-section, and all rights to the Agent’s indemnification, shall be considered void if the Agent exemplifies any willful acts of gross negligence; Maintain the Property in a condition fit for human habitation as required by applicable State and local laws; Pay all interest on Tenants’ security deposits if required by applicable laws; Carry and pay for: Public and premises liability insurance in an amount of no less than one-million dollars ($1,000,000.00); and Property damage and worker’s compensation insurance adequate to protect the interests of the Owner and the Agent. The Agent shall be, and the Owner authorizes Agent to be, named as an additional insured party on the Owner’s policies; and Pay any late charges, penalties and/or interest imposed by lenders or other parties for failure to make payment only if the failure is due to insufficient funds in the Agent’s trust account available for such payment. In addition, the Owner agrees to replace any funds required if there are insufficient funds in the Agent’s trust account to cover such responsibilities of the Owner.

  • Responsibilities of Both Parties 6.1 The CLEC providing the circuit between CLEC’s office and SBC-12STATE’s office shall make such circuits available for use in connection with the DA services covered herein. When the total traffic exceeds the capability of the existing circuits, additional circuits will be provided by the CLEC. 6.2 Where applicable, if additional ADAX cards and ASN Routers (with sync and token ring cards) are necessary, they will be provided by SBC-12STATE, and CLEC will reimburse SBC-12STATE for the cost, plus Engineering, Furnish and Installation.

  • 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).

  • Responsibilities of Adviser In carrying out its obligations under this Agreement, the Adviser agrees that it will: (a) Comply with all applicable law, including but not limited to the 1940 Act and the Advisers Act, the rules and regulations of the Commission thereunder, and the conditions of any order affecting the Trust or a Fund issued thereunder; (b) Use the same skill and care in providing such services as it uses in providing services to other fiduciary accounts for which it has investment responsibilities; (c) Not make loans to any person for the purpose of purchasing or carrying Fund shares; (d) Place, or arrange for the placement of, all orders pursuant to its investment determinations for the Funds either directly with the issuer or with any broker or dealer (including any affiliated broker or dealer). In executing portfolio transactions and selecting brokers or dealers, the Adviser will use its best efforts to seek on behalf of each Fund the best overall terms available. In assessing the best overall terms available for any transaction, the Adviser shall consider all factors that it deems relevant, including the breadth of the market in the security, the price of the security, the financial condition and execution capability of the broker or dealer, and the reasonableness of the commission, if any, both for the specific transaction and on a continuing basis. In evaluating the best overall terms available, and in selecting the broker or dealer to execute a particular transaction, the Adviser may also consider whether such broker or dealer furnishes research and other information or services to the Adviser; (e) Adhere to the investment objective, strategies and policies and procedures of the Trust adopted on behalf of each Fund; and (f) Maintain a policy and practice of conducting its investment advisory services hereunder independently of the commercial banking operations of its affiliates. In making investment recommendations for a Fund, the Adviser's investment advisory personnel will not inquire or take into consideration whether the issuers (or related supporting institutions) of securities proposed for purchase or sale for the Fund's account are customers of the commercial departments of its affiliates. In dealing with commercial customers, such commercial departments will not inquire or take into consideration whether securities of those customers are held by the Fund.

  • Local Professional Development Committee A. There shall be a Local Professional Development Committee (LPDC) to oversee, review, and approve individual professional development plans (IPDP) for course work, continuing education units and/or other equivalent activities. 1. The LPDC shall be responsible to recommend for the Superintendent’s approval, all in-service activities and workshops offered in the district during the school year for staff professional development. 2. Recommendations for District Workshops and In-Service activities should be submitted to the LPDC for approval and recommendation no later than the last school day of the year prior to the year it will be implemented. 3. The LPDC chair shall review and approve all “Professional Growth Reimbursement Application” forms. B. The LPDC shall consist of three (3) teachers appointed by the Association President and two (2) members appointed by the Superintendent. One of the Superintendent's appointees will be a Principal employed by the district. C. Appointments shall be for two (2) years with half of the committee members being appointed every other year. 1. Appointments shall be made on or before May 1. 2. The Appointments shall be made by each party outlined above, notifying the other of those appointed. 3. In the event of a vacancy, the committee members shall be replaced in accordance with "B." above. 4. The Association shall name a fourth teacher member and the Superintendent shall name a third administrative member to serve as alternates and attend trainings. These two (2) people shall act as substitutes when a committee member is absent. D. This committee shall meet monthly. 1. The committee may also be convened by the request of two sitting members. 2. A quorum shall consist of five (5) members. When administrative licenses/certificates are reviewed, two (2) sitting teacher members will abstain and the decision will be decided by three (3) members. 3. If the committee determines it is needed, they will be provided two (2) professional release days to meet during regular school hours. Substitutes will be provided for the committee members on these release days. 4. Committee members shall be provided an additional annual stipend of $1,000 for meetings beyond the normal work day or year. This stipend shall be paid in two (2) semi-annual payments. Any member who fails to serve the full year shall have the above compensation prorated on a monthly basis for each month served. 5. Decisions of the LPDC will be made by consensus of the committee members present. 6. The committee minutes shall be prepared and maintained in compliance with the laws governing the operation of committees of public bodies.

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