THE STUDY. 2.1The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable:
THE STUDY. The study consists of short circuit/fault duty, steady state (thermal and voltage) and stability analyses. The short circuit/fault duty analysis would identify direct Interconnection Facilities required and the Network Upgrades necessary to address short circuit issues associated with the Interconnection Facilities. The stability and steady state studies would identify necessary upgrades to allow full output of the proposed Large Generating Facility and would also identify the maximum allowed output, at the time the study is performed, of the interconnecting Large Generating Facility without requiring additional Network Upgrades.
THE STUDY. The Interconnection Study for Network Resource Interconnection Service shall assure that Interconnection Customer's Large Generating Facility meets the requirements for Network Resource Interconnection Service and as a general matter, that such Large Generating Facility's interconnection is also studied with Transmission Provider's Transmission System at peak load, under a variety of severely stressed conditions, to determine whether, with the Large Generating Facility at full output, the aggregate of generation in the local area can be delivered to the aggregate of load on Transmission Provider's Transmission System, consistent with Transmission Provider's reliability criteria and procedures. This approach assumes that some portion of existing Network Resources are displaced by the output of Interconnection Customer's Large Generating Facility. Network Resource Interconnection Service in and of itself does not convey any right to deliver electricity to any specific customer or Point of Delivery. The Transmission Provider may also study the Transmission System under non-peak load conditions. However, upon request by the Interconnection Customer, the Transmission Provider must explain in writing to the Interconnection Customer why the study of non-peak load conditions is required for reliability purposes.
THE STUDY. The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidance governing the conduct of clinical research in the jurisdiction of the Study; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); and the NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement, and any other relevant NHMRC publication or guideline that relates to clinical trials. If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Institution must notify the Sponsor and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. From time to time, the Sponsor may modify the Protocol by written notice to the Institution and Principal Investigator. Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC. If the parties determine that a modification will affect the cost of the Study, the parties shall amend Schedule 2 as agreed between them. PRINCIPAL INVESTIGATOR Role of Principal Investigator The Institution has authorised the Principal Investigator as the person responsible on a day-to-day basis for the conduct of the Study. The Principal Investigator does not have authority on behalf of the Institution to amend this Agreement or the Protocol.
THE STUDY. The parties must comply with, and conduct the Study in accordance with the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidances governing the conduct of clinical research in the jurisdiction of the Study; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); the NHMRC National Statement on Ethical Conduct in Human Research (2007) or replacement, and any other relevant NHMRC publication or guideline that relates or may relate to clinical trial; any Study specific and standard operating procedures provided by the CRG prior to the commencement of the Study; and any reasonable direction given by the CRG in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements. If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Institution must notify the CRG and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. From time to time, the CRG may modify the Protocol by written notice to the Institution and Principal Investigator. Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC. If the parties determine that a modification will affect the cost of the Study, the parties shall amend Schedule 2 as agreed between them. PRINCIPAL INVESTIGATOR
THE STUDY. 2.1The Institution shall conduct the Study in accordance with the Protocol, as the same may be changed from time to time thereafter and in accordance with prudent research practises. The Investigator shall, where required by applicable law, submit the Protocol for review and approval to its Human Research Ethics Committee / Institutional Review Board or equivalent body in accordance with applicable law, and to an independent review committee of scientists or other qualified individuals as set forth in the Declaration of Helsinki having similar jurisdiction (any such board, body or committee referred to hereinafter as the “IRB”). Changes to the Protocol may be made (i) in accordance with the procedures outlined in the Protocol or (ii) by agreement of the Investigator, Institution and Sponsor. Changes to the Protocol shall be accompanied by such notification, review and/or approval of the IRB as may be required by applicable and and/or the Protocol.
THE STUDY. Laboratory shall render the Services as set forth in a Protocol and/or Scope of Work, Letter of Payment Authorization and Letter of Commitment (the Protocol and/or Scope of Work, Letter of Payment Authorization and Letter of Commitment are collectively referred to here as the “Supporting Documents”). A “Protocol” and/or “Scope of Work” shall mean an attachment to this Agreement describing the nature, design and scope of the Study and the schedule of work to be performed during the course of an individual Study conducted by Laboratory for the Sponsor. A “Letter of Payment Authorization” shall mean an attachment to this Agreement that describes with respect to a particular Study the price, fees and payment schedule for that Study and any modifications of the terms of this Agreement as applied to a particular Study. A “Letter of Commitment” shall mean an attachment to this Agreement that describes a commitment of space and resources by the Laboratory. In the event of a conflict between the terms contained in the Supporting Documents and this Agreement, the terms of this Agreement shall control, unless specifically agreed upon to the contrary in the Supporting Documents. The Supporting Documents when signed by Laboratory and Sponsor shall be incorporated into and made a part of this Agreement.
THE STUDY. 2.1The Parties shall comply, and conduct the Study in accordance, with the Protocol, the terms and conditions imposed by the IRB (if any), the terms and conditions set forth in this Agreement, as well as the following: the ICH GCP; the ethical principles of the Declaration of Helsinki; any and all orders and mandates of the Regulatory Authorities; all laws, rules, regulations, guidance and guidelines applicable to the conduct of the Study as applicable in the respective jurisdictions of the Parties including, but not limited to all applicable Singapore laws, guidance, guidelines and regulations governing the conduct of clinical studies, and the Protocol. For the avoidance of doubt, the Institution shall comply only with Singapore laws, rules, regulations, guidance, and guidelines; and any Study-related instructions given by the Sponsor, any of its Affiliates or a third party authorised by the Sponsor. any and all orders and mandates of the relevant authorities and IRB and/or ethic committees. ((a) to (f) collectively referred to as “Applicable Laws”.) The Study shall not commence until: all the necessary approvals of the relevant Regulatory Authority(ies) and the IRB have been obtained in writing by the Sponsor and the Institution; the written approval of relevant authority(ies) or organisation that owns or is responsible for the administration of the Study Site has been obtained, if such authority or organisation is not the Institution; and the Informed Consent Form as provided by the Sponsor, has been approved by the IRB and the relevant Regulatory Authority(ies).
THE STUDY. 1.1 The Company hereby undertakes to finance performance of the Study for a period of two years (“Study Period”) in accordance with the Study Program or any amendment thereof. Such financing shall be, subject to any earlier termination of the Study pursuant to section 1.2, below, in an amount of NIS 749,249 (Seven Hundred Forty Nine Thousand and Two Hundred and Forty Nine NIS) plus VAT (inclusive of overhead) (the “Study Fee”) payable as follows: (i) on September 1st 2018 [ ] plus VAT and (ii) on the six (6) months anniversary of the Effective Date, [ ]
THE STUDY. 1.1 The Study under this Agreement will be conducted under the protocol approved by SKI/MEMORIAL's Human Subject Institutional Review Board (hereinafter "IRB"), based on the protocol annexed hereto as Exhibit A (hereinafter "Protocol").
