Phase II studies (Task Responsibility; Sanofi Pasteur Sample Clauses

Phase II studies (Task Responsibility; Sanofi Pasteur. Once a single protein candidate [**] has been determined to be immunogenic, able to induce [**] and displaying an acceptable safety profile a series of Phase II studies will be undertaken. Phase II studies are carried out in the final target population for immunisation and are aimed at confirming the immunogenicity observed in Phase I and at determining the final composition of the vaccine (dose-ranging, and determination of the immunisation schedule). These Phase II studies are an important part of the regulatory submission and must be powered to confirm the statistical hypothesis. Accordingly, [**]will be selected for dose-optimisation in Phase II studies of similar design to the Phase I studies. The [**] Schedule 1 Appendix 3 1 vaccine will be evaluated in descending age groups starting with adults [**] with approximately [**] subjects to be included. Once this is complete development would continue [**] with approximately [**] subjects in each age group and [**] again approximately [**] subjects. [**]. It is anticipated that further proteins [**].
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Related to Phase II studies (Task Responsibility; Sanofi Pasteur

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • 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 Occupational Health and Safety Committee The Employer and the Union recognize the role of the joint Occupational Health and Safety Committee in promoting a safe and healthful workplace. The parties agree that a Joint Occupational Health and Safety Committee shall be established for each Employer covered by this Collective Agreement. The Committee shall govern itself in accordance with the provisions of the Industrial Health and Safety Regulations made pursuant to the Workers’ Compensation Act. The Committee shall be as between the Employer and the Union, with equal representation, and with each party appointing its own representatives. Representatives of the Union shall be chosen by the Union membership or appointed by the Union. All minutes of the meetings of the Joint Occupational Health & Safety Committee will be recorded in a mutually agreeable format and will be sent to the Union. The Union further agrees to actively pursue with the other Health Care Unions a Joint Union Committee for the purposes of this Article. The Employer agrees to provide or cause to be provided to Employer members of the Joint Occupational Health and Safety Committee adequate training and orientation to the duties and responsibilities of committee members to allow the incumbents to fulfil those duties competently. The Union agrees to provide or cause to be provided to Union members of the Joint Occupational Health and Safety Committee adequate training and orientation to the duties and responsibilities of committee members to allow the incumbents to fulfil those duties competently. Such training and orientation shall take place within six (6) months of taking office.

  • Patent Filing Responsibilities and Costs 1. The invention and patent rights herein apply to any patent application or patents covering an invention made under this Agreement. Each Party is responsible for its own costs of obtaining and maintaining patents covering sole inventions of its employees. The Parties may agree otherwise, upon the reporting of any invention (sole or joint) or in any license granted. 2. Partner shall include the following in patent applications for an invention made jointly between NASA employees, its Related Entity employees and Partner employees: The invention described herein may be manufactured and used by or for the U.S. Government for U.S. Government purposes without the payment of royalties thereon or therefore.

  • Contractor Responsibility for System Agency’s Termination Costs If the System Agency terminates the Contract for cause, the Contractor shall be responsible to the System Agency for all costs incurred by the System Agency and the State of Texas to replace the Contractor. These costs include, but are not limited to, the costs of procuring a substitute vendor and the cost of any claim or litigation attributable to Contractor’s failure to perform any Work in accordance with the terms of the Contract.

  • 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.

  • 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.

  • Function of Joint Health and Safety Committee All incidents involving aggression or violence shall be brought to the attention of the Joint Health and Safety Committee. The Employer agrees that the Joint Health and Safety Committee shall concern itself with all matters relating to violence to staff.

  • PRIME CONTRACTOR RESPONSIBILITY The contractor will be required to assume prime contractor responsibility for the contract and will be the sole point of contact with regard to all commodities, services and support. The prime contractor may delegate facilitation of contract orders to their “Authorized/Certified Dealers” only. This delegation will in no way relieve the contractor of any contractual obligations set forth in this Contract Award.

  • Contractor Responsibility and Debarment The following requirements set forth in the County’s Non-Responsibility and Debarment Ordinance (Title 2, Chapter 2.202 of the County Code) are effective for this Agreement, except to the extent applicable State and/or federal laws are inconsistent with the terms of the Ordinance. A. A responsible Contractor is a Contractor who has demonstrated the attribute of trustworthiness, as well as quality, fitness, capacity and experience to satisfactorily perform the contract. It is the County’s policy to conduct business only with responsible contractors. B. The Contractor is hereby notified that, in accordance with Chapter 2.202 of the County Code, if the County acquires information concerning the performance of the Contractor on this or other Agreements which indicates that the Contractor is not responsible, the County may, in addition to other remedies provided in the Agreement, debar the Contractor from bidding or proposing on, or being awarded, and/or performing work on County Agreements for a specified period of time, which generally will not exceed five years but may exceed five years or be permanent if warranted by the circumstances, and terminate any or all existing Agreements the Contractor may have with the County. C. The County may debar a Contractor if the Board of Supervisors finds, in its discretion, that the Contractor has done any of the following: (1) violated a term of an Agreement with the County or a nonprofit corporation created by the County; (2) committed an act or omission which negatively reflects on the Contractor’s quality, fitness or capacity to perform a contract with the County, any other public entity, or a nonprofit corporation created by the County, or engaged in a pattern or practice which negatively reflects on same; (3) committed an act or offense which indicates a lack of business integrity or business honesty, or (4) made or submitted a false claim against the County or any other public entity. D. If there is evidence that the Contractor may be subject to debarment, the Department will notify the Contractor in writing of the evidence which is the basis for the proposed debarment and will advise the Contractor of the scheduled date for a debarment hearing before the Contractor Hearing Board. E. The Contractor Hearing Board will conduct a hearing where evidence on the proposed debarment is presented. The Contractor and/or the Contractor’s representative shall be given an opportunity to submit evidence at that hearing. After the hearing, the Contractor Hearing Board shall prepare a tentative proposed decision, which shall contain a recommendation regarding whether the contractor should be debarred, and, if so, the appropriate length of time of the debarment. The Contractor and the Department shall be provided an opportunity to object to the tentative proposed decision prior to its presentation to the Board of Supervisors. F. After consideration of any objections, or if no objections are submitted, a record of the hearing, the proposed decision and any other recommendation of the Contractor Hearing Board shall be presented to the Board of Supervisors. The Board of Supervisors shall have the right to modify, deny or adopt the proposed decision and recommendation of the Hearing Board. G. If a Contractor has been debarred for a period longer than five (5) years, that Contractor may, after the debarment has been in effect for at least five (5) years, submit a written request for review of the debarment determination to reduce the period of debarment or terminate the debarment. The County may, in its discretion, reduce the period of debarment or terminate the debarment if it finds that the Contractor has adequately demonstrated one or more of the following: (1) elimination of the grounds for which the debarment was imposed; (2) a bona fide change in ownership or management; (3) material evidence discovered after debarment was imposed; or (4) any other reason that is in the best interests of the County. H. The Contractor Hearing Board will consider a request for review of a debarment determination only where (1) the Contractor has been debarred for a period longer than five (5) years; (2) the debarment has been in effect for at least five (5) years; and (3) the request is in writing, states one or more of the grounds for reduction of the debarment period or termination of the debarment, and includes supporting documentation. Upon receiving an appropriate request, the Contractor Hearing Board will provide notice of the hearing on the request. At the hearing, the Contractor Hearing Board shall conduct a hearing where evidence on the proposed reduction of debarment period or termination of debarment is presented. This hearing shall be conducted and the request for review decided by the Contractor Hearing Board pursuant to the same procedures as for a debarment hearing. I. The Contractor Hearing Board’s proposed decision shall contain a recommendation on the request to reduce the period of debarment or terminate the debarment. The Contractor Hearing Board shall present its proposed decision and recommendation to the Board of Supervisors. The Board of Supervisors shall have the right to modify, deny, or adopt the proposed decision and recommendation of the Contractor Hearing Board. J. These terms shall also apply to subcontractors of County Contractors.

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