Conduct of Individual Studies Sample Clauses

Conduct of Individual Studies. 2. P rovádění jednotlivých studií Ethics Approval and Informed Consent. An Independent Ethics Committee or its local equivalent (“EC”), established and constituted in accordance with Applicable Law (defined below), approves and oversees the conduct of each Study. Institution will fulfil its obligations under applicable legislation,. Investigator shall obtain from each person enrolling in the Study, prior to the subject’s participation in the Study (a “Study Subject”), their consent to participate in the study on a valid written informed consent form (“ICF”) and document it as required by Applicable Law (defined below). The valid ICF shall be delivered to Investigator by Abbott. The ICF must permit Abbott and its representatives to access, process, obtain copies, transfer and retain Study data under applicable legal regulations. The Institution and the Investigator will comply with the terms of the consent, the Protocol, Xxxxxx’x instructions, and any guidance provided by the EC. EC will notify Abbott and the Institution immediately in case of Study approval withdrawal. Schválení etických komisí a informovaný souhlas Nezávislá etická komise (xxxx xxx „EK“), zřízená a ustanovená v souladu s platnými zákony (definovanými níže), schvaluje jednotlivé Studie a dohlíží na jejich provádění. Zdravotnické zařízení bude plnit své povinnosti v rámci platných právních předpisů. Zkoušející lékař xxxxx xx každé osoby zařazené do Studie, před účastí subjektu ve studii (xxxx xxx „Studijní subjekt“) jeho souhlas s účastí ve studii na platném formuláři písemného informovaného souhlasu (xxxx xxx „ICF“) a zdokumentuje jej, jak vyžadují platné zákony (definované níže). Platný formulář ICF bude Zkoušejícímu lékaři dodán společností Abbott. ICF musí společnosti Abbott a jejím zástupcům povolit přístup, zpracování, získávání kopií, přenos a uchovávání studijních údajů v rámci platných právních předpisů. Zdravotnické zařízení a Zkoušející lékař budou dodržovat podmínky souhlasu, protokol, pokyny společnosti Abbott a jakékoli pokyny poskytnuté Evropskou komisí. V případě, že EK odejme schválení Studie, neprodleně o xxx uvědomí společnost Abbott a Zdravotnické zařízení.
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Conduct of Individual Studies 

Related to Conduct of Individual Studies

  • Conduct of the Study The Parties shall perform the Study set forth in Protocol No. [ ] dated [ ] (“Protocol”) in accordance with this Agreement, the Protocol and all applicable laws and regulations. The Institution shall follow all guidelines and instructions reasonably provided by Sponsor. [If applicable:] The Principal Investigator has, in addition to his/her Principal Investigator responsibilities, been appointed to coordinate certain activities at a national level as National Coordinating Investigator. It is the duty of the National Coordinating Investigator to obtain all approvals for the Study required pursuant to Norwegian law or regulatory requirements from the relevant Independent Ethics Committee (“IEC”) before commencing the Study. The National Coordinating Investigator shall also, to the extent required pursuant to Norwegian law or regulatory requirements, notify and obtain the consent of the relevant EC of any amendments to the Protocol. Such approvals shall be forwarded to Sponsor as they are obtained.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Conduct of the Parties The parties will not engage in behaviour that is, or may reasonably be considered to be intimidating, bullying, or harassing or commit any act or behaviour which is offensive or abusive in connection with this Agreement.

  • Conduct of the Business Each of the Company and Parent covenants and agrees that:

  • Submission and Approval The Contractor’s Submittals must comply with the Contract Documents. The Contractor shall review and approve all Submittals prior to submission. The Contract Documents shall specify when shop drawings or submittals require the seal of a specialty consultant. The Contractor shall submit copies of Submittals as required by the Contract Documents for the Work of the various trades. The Design Professional shall review, approve, or take other appropriate action with respect to shop drawings, samples, or other submissions of the Contractor, including, but not limited to, confirming conformance with the design concept of the Project and with the Contract Documents. The Design Professional shall respond to and return said items to the Contractor within fourteen calendar days from receipt provided that the Submittals are submitted by the Contractor in accordance with the required Submittal schedule. The Design Professional shall review and give comment or approval to Submittal schedule within fourteen calendar days from receipt. Large submittal documents may require longer review times, e.g., submittals with over fifty sheets of drawings. If, because of events beyond its reasonable control, the Design Professional is not able to meet the specified time period, then it is entitled to ask for additional time from the Owner. The Contractor shall make all corrections required by the Design Professional and furnish such corrected copies as may be needed. If the Contractor believes that any corrections required by the Design Professional constitute a change to the contract, the Contractor shall immediately notify the Design Professional and Owner and request instructions. By forwarding the approved Submittals to the Design Professional, the Contractor represents that the Contractor has determined and verified materials, field measurements, and field construction criteria related thereto, or will do so, and has checked and coordinated the information contained within such Submittals with the requirements of the Work and of the Contract Documents. The Design Professional’s approval of Submittals shall not relieve the Contractor from the responsibility for errors of any sort in Submittals or schedules. The Contractor shall perform no portion of the Work for which the Contract Documents require Submittals until the Design Professional has approved the respective Submittal. The Contractor shall maintain at the Site one copy of all approved Submittals.

  • Conduct of Claims 31.6.1 The Indemnifying Party may at its own expense and with the assistance and co-operation of the Indemnified Party have the conduct of the Third Party Claim including its settlement and the Indemnified Party will not, unless the Indemnifying Party has failed to resolve the Third Party Claim within a reasonable period (and the Indemnified Party has notified the Indemnifying Party in writing that it is of the opinion that such reasonable period has expired), take any action to settle or pursue the Third Party Claim

  • Special Studies Providing planning services, site evaluations, environmental studies, or comparative studies of prospective sites, preparing special surveys, studies, and submissions required under Applicable Law.

  • Conduct of the Project C.1. The Proposer agrees to do the work set out in the Proposal in accordance with good standards relevant to such undertakings, and shall expend funds received hereunder only in accordance with such Proposal and the requirements of this Agreement.

  • Ownership of Improvements All modifications, alterations and improvements made or added to the Leased Premises by Tenant (other than Tenant’s inventory, equipment, movable furniture, wall decorations and trade fixtures) shall be deemed real property and a part of the Leased Premises, but shall remain the property of Tenant during the Lease, and Tenant hereby covenants and agrees not to grant a security interest in any such items to any party other than Landlord. Any such modifications, alterations or improvements, once completed, shall not be altered or removed from the Leased Premises during the Lease Term without Landlord’s written approval first obtained in accordance with the provisions of Paragraph 6.1 above. At the expiration or sooner termination of this Lease, all such modifications, alterations and improvements other than Tenant’s inventory, equipment, movable furniture, wall decorations and trade fixtures, shall automatically become the property of Landlord and shall be surrendered to Landlord as part of the Leased Premises as required pursuant to Article 2, unless Landlord shall require Tenant to remove any of such modifications, alterations or improvements in accordance with the provisions of Article 2, in which case Tenant shall so remove same. Landlord shall have no obligations to reimburse Tenant for all or any portion of the cost or value of any such modifications, alterations or improvements so surrendered to Landlord. All modifications, alterations or improvements which are installed or constructed on or attached to the Leased Premises by Landlord and/or at Landlord’s expense shall be deemed real property and a part of the Leased Premises and shall be property of Landlord. All lighting, plumbing, electrical, heating, ventilating and air conditioning fixtures, partitioning, window coverings, wall coverings and floor coverings installed by Tenant shall be deemed improvements to the Leased Premises and not trade fixtures of Tenant.

  • Conduct of Logging Unless otherwise specifi- cally provided herein, Purchaser shall fell trees desig- nated for cutting and shall remove the portions that meet Utilization Standards, as provided in B2.2, prior to accep- tance of subdivision for completion of logging under B6.36. Forest Service may make exceptions for occa- sional trees inadvertently not cut or trees or pieces not removed for good reason, including possible damage to forest resources or gross economic impracticability at the time of removal of other timber. Logging shall be con- ducted in accordance with the following, unless C6.4 pro- visions set forth requirements to meet special or unusual logging conditions:

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