Performance of the Clinical Sample Clauses

Performance of the Clinical. Trial 1.1 The parties agree that the Protocol, including any subsequent Protocol amendments, if not attached hereto but known to all parties, and the Exhibits form an integral part of this Agreement. 1.2 Institution and Principal Investigator agree to use their best efforts and professional expertise to perform the Clinical Trial in accordance with the Protocol, all applicable legal and regulatory requirements, the identified timelines and the terms and conditions of this Agreement. Institution and Principal Investigator may not start the clinical trial without prior approval of the ethics committee, notifications and further legally required approvals. 1.3 In the event that the Principal Investigator becomes no longer affiliated with Institution, Institution shall provide written notice to Sponsor and CRO as soon as possible and at the latest within three (3) calendar days of such departure. Sponsor or CRO on behalf of the Sponsor shall have the right to approve any new Principal Investigator designated by Institution. The new Principal Investigator shall be required to agree to the terms and conditions of this Agreement. In the event Sponsor does not approve such new Principal Investigator, Sponsor may terminate this Agreement in accordance with Section 2.2 below and Institution shall take all necessary steps to accommodate Sponsor’s decision. If Principal Investigator is to be temporarily absent from Institution for more than 10 days, but not more than 14 days, Institution will designate a Sub-investigator to temporarily supervise the Study on the Principal Investigator’s behalf. Institution will document this designation and notify Sponsor in writing of such designation prior to its commencement. If Principal Investigator is, or is to be, absent for more than 14 days, Sponsor may terminate Agreement if Institution and Sponsor cannot agree on a replacement Principal Investigator within a 14-day period. 1.4 Institution and Principal Investigator may appoint such other individuals and investigational staff as they may deem appropriate as co-investigator or investigational staff to assist in the conduct of the Clinical Trial. All co-investigators and investigational staff will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of co-investigators and investigational staff, who in all respect shall be bound to the same terms and conditions as the Principal Inves...
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Performance of the Clinical. Trial 1.1 The parties agree that the Protocol, including any subsequent Protocol amendments, if not attached hereto but known to all parties, and the Exhibits form an integral part of this Agreement. 1.2 Institution and Principal Investigator agree to use their best efforts and professional expertise to perform the Clinical Trial in accordance with the Protocol, all applicable legal and regulatory requirements, the identified timelines and the terms and conditions of this Agreement. Institution
Performance of the Clinical. Trial 1.1 The parties agree that the Protocol, including any subsequent Protocol amendments, if not attached hereto but known to all parties, and the Exhibits form an integral part of this Agreement. 1.2 Institution and Principal Investigator agree to use their best efforts and professional expertise to perform the Clinical Trial in accordance with the Protocol, all applicable legal and regulatory requirements, the identified timelines and the terms and conditions of this Agreement. Institution and Principal Investigator may not start the clinical trial without prior approval of the ethics committee, notifications and further legally required approvals. 1.3 In the event that the Principal Investigator becomes no longer affiliated with Institution, Institution shall provide written notice to Sponsor and CRO as soon as Zdravotnické zařízení bere na vědomí, že ZADAVATEL spolu s touto smlouvou podepíše současně také smlouvu s hlavním zkoušejícím ohledně činností, které má hlavní zkoušející během klinického hodnocení vykonávat a které jdou nad rámec činností, za které je na základě této smlouvy, odpovědné zdravotnické zařízení. V této smlouvě s hlavním zkoušejícím bude specifikována odměna pro hlavního zkoušejícího a členy týmu, provádějícího klinické hodnocení, za provádění těchto činností. Zdravotnické zařízení bere na vědomí a souhlasí s xxx, že odměna za služby poskytované pro účely klinického hodnocení hlavním zkoušejícím a členy týmu provádějícího klinické hodnocení na základě těchto samostatných smluv, může být vyplacena přímo hlavnímu zkoušejícímu a členům týmu provádějícího klinické hodnocení. Se nyní proto, s ohledem na výše uvedené skutečnosti a vzájemné sliby a ujednání vyjádřené v této Smlouvě, Strany dohodly následovně: 1. Provedení Klinického hodnocení 1.1 Strany souhlasí, že Protokol, včetně veškerých následných dodatků k Protokolu, pokud nejsou k této Smlouvě přiloženy, ale jsou všem stranám známy, jakož i přílohy této Smlouvy tvoří její nedílnou součást.
Performance of the Clinical. Trial 1.1 Institution and Principal Investigator agrees to use best efforts and professional expertise to perform the Clinical Trial in accordance with the Protocol, all applicable legal and regulatory requirements, such as regulation No 140/1998 subsequently amended, regulation No. 428/2002 subsequently amended, regulation No.576/2004 subsequently amended, approved by State Institute for Drug Control No. 2010/1914/SBLKS on 24.3.2011, approved by Ethic Commitee No. EK/10/37 on 9.12.2010 and with the identified timelines and the terms and conditions of this Agreement.

Related to Performance of the Clinical

  • PERFORMANCE OF THE CONTRACT II.1.1. The Contractor shall perform the Contract to the highest professional standards. The Contractor shall have sole responsibility for complying with any legal obligations incumbent on him, notably those resulting from employment, tax and social legislation. II.1.2. The Contractor shall have sole responsibility for taking the necessary steps to obtain any permit or licence required for performance of the Contract under the laws and regulations in force at the place where the tasks assigned to him are to be executed. II.1.3. Without prejudice to Article II.3 any reference made to the Contractor’s staff in the Contract shall relate exclusively to individuals involved in the performance of the Contract. II.1.4. The Contractor must ensure that any staff performing the Contract have the professional qualifications and experience required for the execution of the tasks assigned to them. II.1.5. The Contractor shall neither represent the Agency nor behave in any way that would give such an impression. The Contractor shall inform third parties that he does not belong to the European public service. II.1.6. The Contractor shall have sole responsibility for the staff who execute the tasks assigned to him. II.1.7. In the event of disruption resulting from the action of a member of the Contractor's staff working on Agency premises or in the event of the expertise of a member of the Contractor's staff failing to correspond to the profile required by the Contract, the Contractor shall replace him without delay. The Agency shall have the right to request the replacement of any such member of staff, stating its reasons for so doing. Replacement staff must have the necessary qualifications and be capable of performing the Contract under the same contractual conditions. The Contractor shall be responsible for any delay in the execution of the tasks assigned to him resulting from the replacement of staff in accordance with this Article. II.1.8. Should any unforeseen event, action or omission directly or indirectly hamper execution of the tasks, either partially or totally, the Contractor shall immediately and on his own initiative record it and report it to the Agency. The report shall include a description of the problem and an indication of the date on which it started and of the remedial action taken by the Contractor to ensure full compliance with his obligations under the Contract. In such event the Contractor shall give priority to solving the problem rather than determining liability. II.1.9. Should the Contractor fail to perform his obligations under the Contract in accordance with the provisions laid down therein, the Agency may - without prejudice to its right to terminate the Contract - reduce or recover payments in proportion to the scale of the failure. In addition, the Agency may impose penalties or liquidated damages provided for in Article II.16.

  • Performance of the Company The Company shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by this Agreement and the Registration Rights Agreement to be performed, satisfied or complied with by the Company at or prior to the Commencement. The Company shall deliver to the Investor on the Commencement Date the compliance certificate substantially in the form attached hereto as Exhibit C (the “Compliance Certificate”).

  • Performance of Reviews The RIRs shall send a request for review to the Operator per email, where they shall specify the areas they request a review for. The Operator must comply with the request by providing the requested information within working days. The review may include an onsite inspection. In this case the RIRs and the Operator must agree on a specific date for the inspection to take place, which may not be later than sixty calendar days from the date of the request.

  • Performance of the Work The Contractor shall perform all of the Work required for the complete and prompt execution of everything described or shown in, or reasonably implied from the Contract Documents for the above referenced Project.

  • Standard of Care; Performance of Employees Consultant shall perform all Services under this Agreement in a skillful and competent manner, consistent with the standards generally recognized as being employed by professionals in the same discipline in the State of California. Consultant represents and maintains that it is skilled in the professional calling necessary to perform the Services. Consultant agrees that all employees and subconsultants shall have sufficient skill and experience to perform the Services assigned to them. Finally, Consultant represents that it, its employees and subconsultants shall have all licenses, permits, qualifications and approvals of whatever nature that are legally required to perform the Services, including a City Business License, and that such licenses and approvals shall be maintained throughout the Term of this Agreement. As provided for in the indemnification provisions of this Agreement, Consultant shall perform, at its own cost and expense and without reimbursement from the City, any services necessary to correct errors or omissions which are caused by the Consultant’s failure to comply with the standard of care provided for herein. Any employee of the Consultant or its sub-consultants who is determined by the City to be uncooperative, incompetent, a threat to the adequate or timely completion of the Project, a threat to the safety of persons or property, or any employee who fails or refuses to perform the Services in a manner acceptable to the City, shall be promptly removed from the Project by the Consultant and shall not be re-employed to perform any of the Services or to work on the Project.

  • Performance of the Services In addition to the Common Articles, it is specified that:

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

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Performance of Services The Contractor is responsible for fully meeting all obligations set forth in the Contract and for providing Product in accordance with the Contract or any Authorized User Agreement.

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

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