Principal Investigator Substitution. If, for any reason, Principal Investigator is unwilling or unable to continue to serve as Principal Investigator for the Study, Institution shall provide prompt written notice thereof to Sponsor. Institution shall consult with Sponsor regarding the appointment of a replacement principal investigator. Any replacement of Principal Investigator will be subject to Sponsor’s prior written approval and he/she must agree in writing to be bound by the terms of this Agreement. If Sponsor does not approve of the proposed replacement, all further enrollment of subjects at the Institution for this Study will cease immediately and, without limitation of any other rights or remedies that Sponsor may have hereunder or as a matter of law, Sponsor may elect to immediately terminate this Agreement, upon written notice to Institution. Institution may not replace Principal Investigator or substantially reduce his/her role in the Study without Sponsor’s prior written consent. 2.

Principal Investigator Substitution. If, for any reason, Principal Investigator is unwilling or unable to continue to serve as principal investigator for the Trial, Institution shall provide prompt written notice thereof to CRO. Institution shall consult with CRO regarding the appointment of a replacement principal investigator. Any replacement Principal Investigator will be subject to CRO’s prior written approval and he/she must agree in writing to be bound by the terms of this Agreement. If Sponsor does not approve of the proposed replacement, all further enrollment of subjects at the Institution for this Trial will cease immediately and, without limitation of any other rights or remedies that CRO and Sponsor may have hereunder or as a matter of law, CRO may elect to immediately terminate this Agreement, upon written notice to Institution on behalf of Sponsor. Institution may not replace Principal Investigator or substantially reduce his/her role in the Trial without CRO’s prior written consent on behalf of Sponsor. jim byl delegován a zdokumentován. Zdravotnické zařízení, prostřednictvím hlavního zkoušejícího, může delegovat povinnosti a odpovědnost na personál zdravotnického zařízení pouze v rozsahu přípustném platnými právními předpisy (definovanými níže), a pouze pokud splňuje požadavky uvedené v této smlouvě.

Principal Investigator Substitution. If, for any reason, Principal Investigator is unwilling or unable to continue to serve as principal investigator for the Trialy, Institution or Principal Investigator shall 1.3 Náhrada hlavného skúšajúceho. Ak z akéhokoľvek dôvodu hlavný skúšajúci nie je ochotný alebo schopný naďalej vykonávať funkciu hlavného skúšajúceho v skúšaní, zdravotnícke zariadenie alebo hlavný provide prompt written notice thereof to Syneos Health. Institution shall consult with Syneos Health regarding the appointment of a replacement principal investigator. Any replacement Principal Investigator will be subject to Syneos Health’s prior written approval and he/she must agree in writing to be bound by the terms of this Agreement. If Sponor does not approve of the proposed replacement, all further enrollment of subjects at the Institution for this Trial will cease immediately and, without limitation of any other rights or remedies that Syneos Health and Sponsor may have hereunder or as a matter of law, Syneos Health may elect to immediately terminate this Agreement, upon written notice to Institution on behalf of Sponsor. Institution may not replace Principal Investigator or substantially reduce his/her role in the Trial without Syneos Health’s prior written consent on behalf of Sponsor. skúšajúci okamžite zašlú písomný oznam spoločnosti Syneos Health. Zdravotnícke zariadenie sa poradí so spoločnosťou Syneos Health ohľadom vymenovania náhradného hlavného skúšajúceho. Akýkoľvek náhradný hlavný skúšajúci bude podliehať predchádzajúcemu písomnému schváleniu spoločnosťou Syneos Health a musí písomne vyjadriť záväzok, že bude viazaný podmienkami tejto zmluvy. Ak zadávateľ neschváli navrhovaného náhradníka, všetko ďalšie zaraďovanie účastníkov v zdravotníckom zariadení do tohto skúšania sa okamžite zastaví, a bez obmedzenia akýchkoľvek iných práv alebo náprav, ktoré tu spoločnosť Syneos Health a zadávateľ môžu mať podľa zákona, spoločnosť Syneos Health sa môže rozhodnúť okamžite ukončiť túto zmluvu písomným oznamom zdravotníckemu zariadeniu v mene zadávateľa. Zdravotnícke zariadenie nesmie nahradiť hlavného skúšajúceho alebo významne obmedziť jeho rolu v skúšaní bez predchádzajúceho písomného súhlasu spoločnosti Syneos Health v mene zadávateľa.

Principal Investigator Substitution. If, for any reason, Principal Investigator is unwilling or unable to continue to serve as principal investigator for the Trial, Institution or Principal Investigator shall provide prompt written notice thereof to CRO. Institution shall consult with CRO regarding the appointment of a replacement principal investigator. Any replacement Principal Investigator will be subject to CRO’s prior jen „subjekty klinického hodnocení“). Zadavatel chce zapojit zdravotnické zařízení, pod vedením hlavního zkoušejícího, do provádění klinického hodnocení, a zdravotnické zařízení chce takové zapojení přijmout, v souladu s podmínkami uvedenými v této smlouvě. PROTO NYNÍ, s ohledem na výše uvedená východiska, vzájemné závazky a dohody uvedené v této smlouvě, a výměnou za úplatu, jejíž přijetí a dostatečnost tímto strany potvrzují, se smluvní strany dohodly takto: 1. Hlavní zkoušející a personál zdravotnického zařízení. 1.1 Hlavní zkoušející. 1). Zdravotnické zařízení tímto prohlašuje a zaručuje, že hlavní zkoušející je a vždy po dobu trvání této smlouvy a během trvání klinického hodnocení bude: (i) mít aktivní všechny profesní licence nezbytné k provedení klinického hodnocení v souladu s platnými právními předpisy, (ii) mít řádnou kvalifikaci formou doloženého vzdělání k provádění klinického hodnocení a provádění funkce hlavního zkoušejícího podle této smlouvy a (iii) bude zodpovědný a schopný koordinovat, delegovat a dohlížet na veškerý personál zdravotnického zařízení (jak je definován níže). Klinické hodnocení bude prováděno pod dohledem hlavního zkoušejícího na adrese Fakultní nemocnice Xxxx, Xxxxxxxxx 00, 000 00 Xxxx, Xxxxx xxxxxxxxx.

Related to Principal Investigator Substitution

Principal Investigator The Research will be supervised by __________________ ("Principal Investigator"). If for any reason the individual is unable to continue to serve as Principal Investigator and a successor acceptable to both the University and the Sponsor is not available, this agreement shall be terminated as provided in Article 9. The Principal Investigator may work with others at the University (“Associates”) in conducting the Research.
Geotechnical Investigation Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.
Submitting Investigator An investigator who submitted a genomic dataset to an NIH designated data repository (e.g., dbGaP).
Investigator Where a difference arises between the parties relating to the dismissal, discipline or suspension of an employee, or to the interpretation, application, operation or alleged violation of this agreement, including any questions as to whether a matter is arbitrable, during the term of the collective agreement, an arbitrator agreed to by the parties shall, at the request of either party: (a) investigate the difference; (b) define the issue in the difference; and (c) make written recommendations to resolve the difference within five days of the date of receipt of the request and for those five days from that date time does not run in respect of the grievance procedure. The parties agree that this procedure will not be invoked until the grievance procedure has been completed.
PRODUCT SUBSTITUTION In the event a specified manufacturer’s Product listed in the Contract becomes unavailable or cannot be supplied by the Contractor for any reason (except as provided for in the Savings/Force Majeure Clause) a Product deemed in writing by the Commissioner to be equal to or better than the specified Product must be substituted by the Contractor at no additional cost or expense to the Authorized User. Unless otherwise specified, any substitution of Product prior to the Commissioner’s written approval may be cause for cancellation of Contract.
Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.
DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK
Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.
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.
Third Party Components The Products and Services may contain third party components (including open source software) subject to separate license agreements. To the limited extent a third party license expressly supersedes this XXXX, such third party license governs Customer’s use of that third party component.

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