Development Team Responsibilities Sample Clauses

Development Team Responsibilities. The DT shall be responsible for: (i) developing an overall strategy for the Development of the Products in the Field in the Territory for review and approval by the JSC; (ii) formulating the Development Plans (including the allocation of Development activities between the Parties) and associated annual budgets and any substantive amendments thereto for review and approval by the JSC, which Development Plans will include the plans for Manufacture development and associated annual budgets and any substantive amendments thereto received by the DT from the ST; (iii) formulating the multiyear long-range plan for Development of the Products in the Field in the Territory (including the budget for Development Costs) for review and approval by the JSC; (iv) implementing in coordination with the ST, as appropriate, all activities pursuant to the Development Plans approved by the JSC; (v) making recommendations for further Development of the Products, including Development of the Products for a New Indication; ** CONFIDENTIAL TREATMENT REQUESTED (vi) in consultation with intellectual property representatives of each Party, developing a strategy, and implementing methods for compliance, to protect trade secrets, know-how and other confidential material, data and information developed, made or conceived by the Parties pursuant to a Development Plan; (vii) in consultation with the CT, developing and co-ordinating a communications and publication strategy for the Products in the Territory;
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Development Team Responsibilities. The DT will perform the following functions: (i) for the Alkermes 8700 Product in the Initial Indication in the U.S., formulating amendments to the Initial Development Plan, including, in each case, the applicable annual budget or the regulatory strategy, in each case, set forth therein; (ii) coordinating implementation of all Development activities for the Alkermes 8700 Product in the Initial Indication in the U.S. pursuant to the Initial Development Plan; (iii) generating forecasts of supply requirements for the Alkermes 8700 Product and Placebo pursuant to the Initial Development Plan and delivering such forecasts to the ST; (iv) exchanging information and facilitating cooperation and coordination between the Parties as they exercise their respective rights and meet their respective obligations under the Initial Development Plan; (v) providing status updates to the JSC regarding Development activities for the Alkermes 8700 Product in the Initial Indication in the U.S. pursuant to the Initial Development Plan, including progress towards achieving key milestone events and Development Cost expenditures; and (vi) performing such other functions as appropriate to further the purposes of this Agreement as determined by mutual agreement of the Parties. In addition, the DT may designate subteams as appropriate to facilitate coordination and cooperation in key areas. The development plan for the Alkermes 8700 Product in the Initial Indication in the U.S. and the accompanying budget are attached hereto as Exhibit C (as amended from time to time in accordance with this Agreement, the “Initial Development Plan”). This Initial Development Plan shall be deemed to have been reviewed and approved by the JSC. The Initial Development Plan attached hereto as Exhibit C covers Development activities for the Alkermes 8700 Product in the Initial Indication in the U.S. through the filing of the Alkermes 8700 Product 505(b)(2) NDA (including the regulatory strategy for obtaining, supporting or maintaining Regulatory Approval of the Alkermes 8700 Product in the Initial Indication in the U.S.). The Initial Development Plan may be amended upon the written agreement of each Party to include additional Development activities for the Alkermes 8700 Product in the Initial Indication in the U.S. but, notwithstanding anything to the contrary set forth under this Agreement, will not include any Post-Marketing Commitments or Post-Marketing Clinical Trials for the Alkermes 8700 Product. The...
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Development Team Responsibilities. (A) As part of its responsibilities, the Development Team shall 28 29 (1) ***;
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Related to Development Team Responsibilities

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market [***]. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Joint Responsibilities The relationship between SAE ITC, the Activities and its Members shall be, and at all times, advisory only, and no party shall have the authority to enter into any contract or commitment in the name of, or on behalf of, any other party. Nothing in this Agreement shall be construed to confer upon either party the status of employee, agent, partner, joint venturer or legal representative of the other, it being intended by all parties to remain independent legal entities solely responsible for its own actions.

  • Specific Responsibilities Without limiting the responsibilities of the Manager, the Manager will: 1. Maintain office facilities (which may be in the offices of the Manager or a corporate affiliate but shall be in such location as the Trust reasonably determines). 2. Furnish statistical and research data, clerical services and stationery and office supplies. 3. Compile data for, prepare for execution by the Fund and file all the Fund’s federal and state tax returns and required tax filings other than those required by this Agreement to be made by the Fund’s custodian and transfer agent. 4. Prepare compliance filings pursuant to state securities laws with the advice of the Trust’s counsel. 5. Prepare the Trust’s Annual and Semi-Annual Reports to Shareholders and amendments to its Registration Statements (on Form N-1A or any replacement therefor). 6. Compile data for, prepare and file timely Notices to the SEC required pursuant to Rule 24f-2 under the 1940 Act. 7. Determine the daily pricing of the portfolio securities and computation of the net asset value and the net income of Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the procedures set forth in EXHIBIT A: NET ASSET VALUE CALCULATIONS. 8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or requested by the Fund. 9. Provide officers for the Trust as requested by the Trust’s Board of Trustees. 10. Perform fund accounting services for the Fund as set forth in EXHIBIT B: FUND ACCOUNTING FUNCTIONS. 11. Generally assist in all aspects of the operations of the Fund.

  • Client Responsibilities You are responsible for (a) assessing each participants’ suitability for the Training, (b) enrollment in the appropriate course(s) and (c) your participants’ attendance at scheduled courses.

  • University Responsibilities 4.1 The University will provide a room accommodation to The Resident for a period of one academic year or the portion of the academic year remaining when occupancy begins (limited to the subsequent fall and spring semesters) exclusive of the Winter Recess period unless The Resident is assigned to a facility that remains open during this time or is approved to live on-campus during Winter Recess. Services provided by the University begin on the official check-in dates for the specific area and include access to the assigned building and room. 4.2 In accordance with University policy, the University will provide staff that will help facilitate a living experience that complements the academic mission of the University. 4.3 Exclusive of unanticipated weather events and building system failures that may disrupt service and subject to the availability of applicable resources, the University will provide adequate light, heat, electricity, hot water and telecommunication services (limited to video and internet connection) to residents. Student rooms shall be furnished.