By CRO Sample Clauses
The "By CRO" clause designates actions, rights, or responsibilities that are specifically to be carried out by the Contract Research Organization (CRO) within an agreement. In practice, this clause clarifies which tasks—such as data collection, regulatory submissions, or reporting—are under the CRO’s purview, distinguishing them from those handled by the sponsor or other parties. Its core function is to ensure clear allocation of duties, reducing ambiguity and potential disputes over who is responsible for specific obligations in the contract.
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By CRO. CRO may freely 17.2 Ze strany CRO. CRO může assign any or all of its rights and delegate any or all of its duties under this Agreement to Pfizer. If CRO assigns all rights and delegates all duties to Pfizer, CRO or Pfizer will notify Principal Investigator and Institution in writing. CRO (or Pfizer, following assignment and delegation by CRO) may also freely delegate and assign Study-related duties and rights to an external provider upon advance notice to Principal Investigator and Institution, and may freely delegate or assign its Study- related duties or rights to any Pfizer affiliate. CRO may not otherwise assign its rights or delegate its duties under this Agreement without written permission from the affected party. If CRO or Pfizer delegates or subcontracts any duties, CRO or Pfizer remains responsible to Principal Investigator or Institution, as applicable, for the performance of those duties. If CRO assigns all of CRO's rights and duties under this Agreement, in accordance with the terms herein, to another service provider, that service provider will become responsible for performance of all duties. For the avoidance of doubt, the rights and duties discussed in this subsection are only those arising out of this Agreement. svobodně postoupit společnosti Pfizer některá nebo všechna svá práva a delegovat na ni některé nebo všechny své povinnosti vyplývající z této Smlouvy. Pokud CRO postoupí společnosti Pfizer všechna svá práva a deleguje na ni všechny své povinnosti, CRO nebo společnost Pfizer oznámí tuto skutečnost písemně Hlavnímu zkoušejícímu a Instituci. Po předchozím oznámení Hlavnímu zkoušejícímu a Instituci může CRO (nebo společnost Pfizer po postoupení práv a delegaci povinností ze strany CRO) též svobodně postoupit práva související se Studií externímu poskytovateli a delegovat na něj příslušné povinnosti a může též svobodně postoupit svá práva související se Studií libovolné přidružené společnosti společnosti Pfizer a delegovat na ni své příslušné povinnosti. Jinak nesmí CRO postoupit svá práva ani delegovat své povinnosti vyplývající z této Smlouvy bez písemného souhlasu dotčené strany. Pokud CRO nebo společnost Pfizer deleguje nebo formou dílčí subdodavatelské smlouvy převede jakékoli povinnosti, CRO nebo společnost Pfizer nadále odpovídá Hlavnímu zkoušejícímu nebo Instituci (podle toho, co připadá v úvahu) za plnění těchto povinností. Pokud CRO postoupí všechna svá práva a deleguje všechny své povinnosti vyplývající z této Smlouvy v soul...
By CRO. CRO may freely assign any or all of its rights and delegate any or all of its duties under this Agreement to Pfizer. If CRO assigns all rights and delegates all duties to Pfizer, CRO or Pfizer will notify Institution in writing. ▇▇▇ (or Pfizer, following assignment and delegation by ▇▇▇) may also freely delegate and assign Study-related duties and rights to an external provider upon advance notice to Institution, and may freely delegate or assign its Study-related duties or rights to any Pfizer affiliate. CRO may not otherwise assign its rights or delegate its duties under this Agreement without written permission from Institution. If CRO or Pfizer delegates or subcontracts any duties, CRO or Pfizer remains responsible to Institution for the performance of those duties. If CRO assigns all of CRO’s rights and duties under this Agreement, in accordance with the terms herein, to another service provider, that service provider will become
By CRO. CRO may freely assign any or all of its rights and delegate any or all of its duties under this Agreement to Pfizer. If CRO assigns all rights and delegates all duties to Pfizer, CRO or Pfizer will notify Principal Investigator and Institution in writing. CRO (or Pfizer, following assignment and delegation by CRO) may also freely delegate and assign Study-related duties and rights to an external provider upon advance notice to Principal Investigator and Institution, and may freely delegate or assign its Study-related duties or rights to any Pfizer affiliate. CRO may not otherwise assign its rights or delegate its duties under this Agreement without written permission from the affected party. If CRO or Pfizer delegates or subcontracts any duties, CRO or Pfizer remains responsible to Principal Investigator or Institution, as applicable, for the performance of those duties. If CRO assigns all of CRO's rights and duties under this Agreement, in accordance with the terms herein, to another service provider, that service provider will become responsible for performance of all duties. For the avoidance of doubt, the rights and duties discussed in this subsection are only those arising out of this Agreement.
By CRO. CRO represents and warrants that the following statements are true and correct as of the Effective Date and will continue to be true and correct for the duration of the term of this Agreement:
(a) CRO has full right, power and authority to enter into this Agreement, and perform its obligations hereunder, without the consent, approval or authorization of any third party;
(b) CRO will render the Services in accordance with recognized standards in the clinical research industry and in compliance with the terms of this Agreement, the terms of the applicable IPA(s) (including use of commercially reasonable efforts to comply with each Project schedule and Project budget contained therein) and upon any standard operating procedures agreed to by the Parties in writing;
(c) CRO will comply with all laws, regulations and ordinances applicable to its performance under this Agreement, and has obtained (or before performing the Services will obtain) all governmental permits and licenses required for it to perform the Services and its other obligations under this Agreement;
(d) CRO will be responsible for the supervision of the Study(ies) and oversight of the Study Sites in accordance with its standard operating policies. CRO represents and warrants that such policies are not inconsistent with the terms of this Agreement, the Protocol, generally acceptable standards of good clinical practice and all applicable local, state and federal laws and regulations governing the performance of clinical investigations;
(e) CRO shall have sufficient staff to perform the Services and the personnel assigned to perform such Services shall have the requisite qualifications, expertise and experience, and CRO shall verify the identity of all such personnel;
(f) CRO will not knowingly, in the course of performing the Services, infringe or misappropriate, and neither the work product resulting from such Services nor any element thereof will knowingly infringe or misappropriate, any intellectual property right of any other person;
(g) CRO will make available to Sponsor, or to the responsible regulatory authority, relevant records, programs and data as may be reasonably requested by Sponsor for purposes related to the filing and/or prosecution of any regulatory applications, including new drug and/or patent applications;
(h) CRO is not a party to any agreement which would prevent it from fulfilling its obligations under this Agreement or impose conflicting obligations on CRO, and CRO agrees ...
By CRO. CRO may freely assign any or all of its rights and delegate any or all of its duties under this Agreement to Pfizer or to another CRO selected by Pfizer. If CRO assigns all rights and delegates all duties to Pfizer, CRO or Pfizer will notify Principal Investigator and Institution in writing. CRO (or Pfizer, following assignment and delegation by CRO) may also freely delegate and assign Study- related duties and rights to an external provider upon advance notice to Institution and Principal Investigator and may freely delegate or assign its Study-related duties or rights to any Pfizer affiliate. CRO may not otherwise assign its rights or delegate its duties under this Agreement without written permission from Institution and Principal Investigator. If CRO or Pfizer delegates or subcontracts any duties, CRO or Pfizer remains responsible to Institution and Principal Investigator for the 17.2 Ze strany CRO. CRO může bez omezení postoupit kterákoli nebo všechna svá práva a delegovat kterékoli nebo všechny své povinnosti podle této smlouvy na společnost Pfizer nebo jinou CRO vybranou společností Pfizer. Pokud CRO postoupí všechna práva a deleguje všechny povinnosti na společnost Pfizer, CRO nebo společnost Pfizer o tom písemně uvědomí hlavního zkoušejícího a zdravotnické zařízení. CRO (nebo společnost Pfizer po postoupení a delegování ze strany CRO) může také po předchozím oznámení zdravotnickému zařízení a hlavnímu zkoušejícímu bez omezení delegovat a postoupit povinnosti a práva související se studií externímu poskytovateli a může bez omezení delegovat nebo postoupit své povinnosti nebo práva související se studií kterémukoli subjektu přidruženému ke společnosti Pfizer. CRO nesmí jinak bez písemného souhlasu zdravotnického zařízení a hlavního zkoušejícího postoupit svá práva ani delegovat své performance of those duties povinnosti podle této smlouvy. Pokud CRO nebo společnost Pfizer delegují nebo subkontrahují kterékoli povinnosti, CRO nebo společnost Pfizer i nadále ponesou vůči zdravotnickému zařízení a hlavnímu zkoušejícímu odpovědnost za plnění těchto povinností.
By CRO. CRO may freely assign any or all of its rights and delegate any or all of its duties under this Agreement to Pfizer. If CRO assigns all rights and delegates all duties to Pfizer, CRO or Pfizer will notify Principal Investigator and Provider in writing. ▇▇▇ (or Pfizer, following assignment and delegation by ▇▇▇) may also freely delegate and assign Study-related duties and rights to an external provider upon advance notice to Principal Investigator and Provider, and may freely
By CRO. CRO may freely assign any or all of its rights and delegate any or all of its duties under this Agreement to Pfizer. If CRO assigns all rights and delegates all duties to Pfizer, CRO or Pfizer will notify Principal Investigator and Institute in writing. CRO (or Pfizer, following assignment and delegation by CRO) may also freely delegate and assign Study-related duties and rights to an external provider upon advance notice to Principal Investigator and Institute, and may freely delegate or assign its Study-related duties or rights to any Pfizer affiliate. CRO may not otherwise assign its rights or delegate its duties under this Agreement without written permission from the affected party. If CRO or Pfizer delegates or subcontracts any duties, CRO or Pfizer remains responsible to Principal Investigator or Institute, as applicable, for the performance of those duties. smlouvy. Smluvní strany tímto sjednávají, že za pšedpokladu dodržení povinných požadavků je společnost Pfizer oprávnena pšíslušnou pojistku v průbehu studie zmenit či upravit.
By CRO. The Sponsor has the right to assign this Agreement in whole or in part to any of its Affiliates. In addition to the above, none of the Contracting Parties is entitled to transfer their rights and/or obligations in whole or in part to a third party without the prior written consent of the other Contracting Parties. This Agreement binds the Contracting Parties, as well as their legal successors and persons to whom the rights and obligations of the Contracting Parties will be transferred in accordance with this article. sčasti na ktorúkoľvek zo svojich Prepojených osôb. Okrem vyššie uvedeného nie je žiadna zo Zmluvných strán oprávnená postúpiť svoje práva a /alebo povinnosti úplne ani sčasti na tretiu stranu bez predchádzajúceho písomného súhlasu ostatných Zmluvných strán. Táto Zmluva zaväzuje Zmluvné strany, ako aj ich právnych nástupcov a osoby, na ktoré budú práva a záväzky ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇ ▇▇▇▇▇▇ ▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇.
By CRO. CRO may freely assign any or all of its rights and delegate any or all of its duties under this Agreement to XXX or to another CRO selected by XXX. If CRO assigns all rights and delegates all duties to XXX, CRO or XXX will notify Institution and nebo postupy vyžadovanými v Protokolu, které by Subjekt studie neutržil, pokud by se Studie neúčastnil. Vzhledem k tomu, že ▇▇▇▇▇▇ ▇▇ observační studií a týká se Subjektů studie, kterým byla léčba Přípravkem společnosti XXX předepsána v rámci standardní zdravotní péče, nebyla by žádná nežádoucí reakce na Produkt společnosti XXX Újmou způsobenou výzkumem. Poskytovatel a Hlavní zkoušející se zavazují poskytnout nebo zajistit rychlé provedení diagnózy a poskytnutí lékařské péče, pokud jakýkoli Subjekt studie utrpí jakoukoli újmu. Poskytovatel a Hlavní zkoušející ▇▇ ▇▇▇▇ zavazují CRO neprodleně informovat o jakékoli újmě, kterou utrpí Subjekt studie. Vzhledem k tomu, že se jedná o observační studii, Poskytovatel, Hlavní zkoušející, CRO ani společnost XXX neposkytují ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇. ▇▇. Postoupení práv a povinností 17.1 Ze strany Poskytovatele a Hlavního řešitele. Bez písemného souhlasu CRO nejsou Poskytovatel ani Hlavní zkoušející oprávněni postoupit svá práva či povinnosti z této Smlouvy nebo využít subdodavatele pro splnění povinností vyplývajících z této Smlouvy. Pokud CRO udělí souhlas s postoupením povinností nebo využitím subdodavatelů, odpovídají Poskytovatel a Hlavní zkoušející i nadále vůči CRO za plnění veškerých postoupených povinností, resp. povinností zadaných ke splnění subdodavatelům.
By CRO. 11.2.1 CRO will fully indemnify and hold harmless the Sponsor and its affiliates, agents, officers and employees from and against all claims and proceedings (to include any settlements or ex gratia payments made with the consent of CRO and all legal and expert costs and expenses) made or brought (whether successful or otherwise) by or on behalf of Trial Subjects taking part in Clinical Trials (or their dependants Estate or Personal Representatives) against the Sponsor, its staff or contractors for personal injury (including death) to Trials Subjects arising out of or relating to the Clinical Trials, the administration of the Investigational Product(s) or any clinical intervention or procedure provided for or required by the Protocol to which the Trial Subjects would not have been exposed but for their participation in the Clinical Trial, which result directly from the gross negligence or wilful default of CRO in the performance of this Agreement.
11.2.2 The above indemnity by CRO shall not apply to any such claim or proceedings:-
(a) to the extent that such personal injury (including death) is caused by the negligent or willful acts or omissions or breach of statutory duty of the Sponsor and its staff and contractors or to the extent that such personal injury (including death) is caused by procedures conducted in accordance with the Protocol;
(b) unless as soon as reasonably practicable following receipt of notice of such claim or proceeding, the Sponsor and its staff and contractors notify CRO in writing of it and upon CRO's request, and at CRO's sole cost, give CRO the option to have full care and control of the claim or proceedings using legal representation of its own choosing, such option to be exercised by giving written notice to the Sponsor within ten days from receipt of notice of such claim or proceeding from the Sponsor:
