Investigational Device Sample Clauses

Investigational Device. The Sponsor, the Institution and the Principal Investigator agree to take all measures required for lawful importation into the Czech Republic of all units of the Device to be used in the Clinical Trials, including obtaining all the necessary authorisation from the Czech customs authorities. The Institution and the Principal Investigator undertake to use the Device only at the Medical Facility not to use the Device other than as specifically stipulated in this Contract or the relevant Clinical Investigation Plan and that only the Principal Investigator or any Sub-Investigator(s) approved in writing by Sponsor shall use the Device. Institution and the Principal Investigator shall not, nor permit any third party to, attempt to alter, open, change or analyse, decompile, disassemble, reverse engineer (or the like) the Device. Institution shall keep traceability and accountability of all Devices. Institution will keep the Device in storage facilities in accordance with the Sponsor's instructions and with Applicable Laws. Should any Device be damaged for any reason, the Institution and Principal Investigator shall promptly return it to the Sponsor. Upon the earlier of, completion of all of the Clinical Trials and/or termination or expiry of this Contract, or at the request of the Sponsor, all units of the Device shall be immediately returned to the Sponsor. The Principal Investigator shall notify the Sponsor immediately with regard to any defects or faults with respect to the Device. The Contracting Parties hereby note that the Device and all other materials and information provided under this Contract are of an experimental nature and are to be used for purposes of the Clinical Trials only. The Sponsor makes no warranties, express or implied, including and without limitation any of the implied warranties of merchantability, fitness for a particular purpose and non-infringement, regarding the Device. Except for the authorized use specified in the Clinical Investigation Plan, Sponsor grants Institution no express or implied intellectual property or other rights in or to the Device or in any methods of making or using the Device. For the avoidance of doubt, all such rights shall vest exclusively with Sponsor.
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Investigational Device. The Sponsor, the Institution and the Principal Investigator agree to take all measures required for lawful importation into the Czech Republic of all units of the Device to be used in the Clinical Trials, including obtaining all the necessary authorisation from the Czech customs authorities. The Institution and the Principal Investigator undertake not to use the Device other than as specifically stipulated in this Contract or the relevant Clinical Investigation Plan. Following completion of all of the Clinical Trials and termination or expiry of this Contract, or at the request of the Sponsor, all units of the Device currently held at the Institution shall be immediately returned to the Sponsor. The Principal Investigator shall notify the Sponsor immediately with regard to any defects or faults with respect to the Device. The Contracting Parties hereby note that the Device and all other materials and information provided under this Contract are of an experimental nature and are to be used for purposes of the Clinical Trials only.
Investigational Device. (LiquiBand FIX8®)‌
Investigational Device. Sponsor shall provide all Devices necessary for conduct of the Trial to the Clinical Team at no charge, pursuant to the terms set forth below and in the Agreement. The parties acknowledge that the Device is comprised of multiple components, including hardware, software, and disposables. The term “Device” refers to the hardware, software and/or disposables, as applicable. Hospital and Clinical Team shall not seek or retain payment from any patient, third-party health insurer or any other person or entity for the Device.
Investigational Device. The definition of an investigational device is a device that is assessed in a clinical investigation, MDR Article 2

Related to Investigational Device

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Investigational Services This plan covers certain experimental or investigational services as described in this section. This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.

  • Background Investigation The BOARD is prohibited from knowingly employing a person who has been convicted of committing or attempting to commit certain criminal offenses. If the required criminal background investigation is not completed at the time this Contract is signed, and the subsequent investigation report reveals that there has been a prohibited conviction, this Contract shall immediately become null and void.

  • Investigation and Prevention DST shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to: (A) cooperate with Fund in its efforts to comply with statutory notice or other legal obligations applicable to Fund or its clients arising out of unauthorized access and to seek injunctive or other equitable relief; (B) cooperate with Fund in litigation and investigations against third parties reasonably necessary to protect its proprietary rights; and (C) take reasonable actions necessary to mitigate loss from any such authorized access.

  • Grievance Investigation The Employer agrees to supply to the Union the names of all applicants for a vacancy, or new position in the course of a grievance investigation.

  • Compliance Investigations Upon City’s request, Contractor agrees to provide to City, within sixty calendar days, a truthful and complete list of the names of all subcontractors, vendors, and suppliers that Contractor has used in the past five years on any of its contracts that were undertaken within San Diego County, including the total dollar amount paid by Contractor for each subcontract or supply contract. Contractor further agrees to fully cooperate in any investigation conducted by City pursuant to City's Nondiscrimination in Contracting Ordinance. Contractor understands and agrees that violation of this clause shall be considered a material breach of the Contract and may result in Contract termination, debarment, and other sanctions.

  • Environmental Investigation (a) Heritage shall engage an environmental consultant acceptable to Acquiror to conduct a preliminary ("Phase I") environmental assessment of each of the parcels of real estate used in the operation of the businesses of Heritage and any Heritage Subsidiary and any other real estate owned by Heritage or a Heritage Subsidiary (other than single family residences). The fees and expenses of the consultant with respect to the Phase I assessments shall be shared equally by Acquiror and Heritage. The consultant shall complete and deliver the Phase I assessments not later than 60 days after the date of this Agreement. If any environmental conditions are found, suspected, or would tend to be indicated by the report of the consultant which may be contrary to the representations and warranties of Heritage set forth herein without regard to any exceptions that may be contained in Heritage's Schedules, then the parties shall obtain from one or more mutually acceptable consultants or contractors, as appropriate, an estimate of the cost of any further environmental investigation, sampling, analysis, remediation or other follow-up work that may be necessary to address those conditions in accordance with applicable laws and regulations. (b) Upon receipt of the estimate of the costs of all follow-up work to the Phase I assessments or any subsequent investigation phases that may be conducted, the parties shall attempt to agree upon a course of action for further investigation and remediation of any environmental condition suspected, found to exist, or that would tend to be indicated by the report of the consultant. All post-Phase I investigations or assessments (the cost of which shall be paid by Heritage), all work plans for any post-Phase I assessments or remediation, and any removal or remediation actions that may be performed, shall be mutually satisfactory to Acquiror and Heritage. If such work plans or removal or remediation actions would cost more than $3,000,000 (individually or in the aggregate on a tax affected basis) to complete, Acquiror and Heritage shall discuss a mutually acceptable modification of this Agreement. Acquiror and Heritage shall cooperate in the review, approval and implementation of all work plans. (c) If the parties are unable to agree upon a course of action for further investigation and remediation of an environmental condition or issue raised by an environmental assessment and/or a mutually acceptable modification to this Agreement, and the condition or issue is not one for which it can be determined to a reasonable degree of certainty that the risk and expense to which the Surviving Corporation and its Subsidiaries would be subject as owner of the property involved can be quantified, in good faith, and limited to an amount less than $3,000,000 (on a tax affected basis), then Acquiror may terminate this Agreement by the earlier to occur of (i) 120 days after the receipt of the Phase I assessments, or (ii) the receipt of all consents and approvals of government regulatory authorities as legally required to consummate the Merger and the expiration of all statutory waiting periods.

  • COMPLAINTS AND INVESTIGATIONS 1. This article applies to complaints or allegations made externally and not from normal supervisory activities. 2. A department head shall be responsible for ensuring that all allegations of misconduct or other complaints against an employee on which any action is to be taken or a record is to be made shall be investigated. The investigator shall be allowed to interview the complainant prior to notifying the employee.

  • Grievance Investigations Where an employee has asked or is obliged to be represented by the Institute in relation to the presentation of a grievance and an employee acting on behalf of the Institute wishes to discuss the grievance with that employee, the employee and the representative of the employee will, where operational requirements permit, be given reasonable leave with pay for this purpose when the discussion takes place in the headquarters area of such employee and leave without pay when it takes place outside the headquarters area of such employee.

  • Regulatory Investigations TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.

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