Poškození zdraví subjektu studie Sample Clauses

Poškození zdraví subjektu studie odškodnění, pojištění a náhrada škody Zadavatel prohlašuje a potvrzuje, že v souladu s ust. § 52 odst. 3, písm. f) zákona č. 378/2007 Sb., o léčivech, v platném znění, zajistí pojištění klinického hodnocení. Poskytovatel je povinen neprodleně písemně vyrozumět Quintiles a Zadavatele o jakémkoli nároku vztahujícím se k onemocnění či újmě na zdraví, k nimž skutečně či údajně došlo v souvislosti s nežádoucí reakcí na Hodnocené léčivo, a zavazuje se plně spolupracovat se Zadavatelem při řešení nežádoucí události. Zadavatel uhradí Poskytovateli náklady na immediate medical treatment of a Study Subject who sustains physical illness or injury as a direct result of the treatment of such Study Subject in accordance with the terms of the Protocol and this Agreement. Sponsor shall indemnify Institution for and against any liability or loss resulting from judgements or claims against them arising out of the physical illness, injury or death of a Study Subject as a direct result of treatment of such subject in accordance with the terms of the Protocol and this Agreement except to the extent that such adverse event, illness or personal injury is caused by: a) failure by Institution, Investigator or any of their respective personnel to comply with this Agreement, the Protocol, any written instructions of Sponsor concerning the Study, or any applicable law, regulation or guidance, including GCPs, issued by any regulatory authority, or b) negligence or willful misconduct by Institution, Investigator or any of their respective personnel; or c) failure of the Study Subject to follow the reasonable instructions of the Investigator relating to the requirements of the Study. The Sponsor’s liability to reimburse the Institution under this provision shall not be limited to the amount payable under any insurance required to be carried by Sponsor but shall extend to the full amount of the Institution’s actual damages in the amount of subject’s claim or of subject's legal representative's claim successfully claimed under Czech legal order. Institution shall not be entitled to such reimbursement according to the previous paragraph if: a) The injury of subject (including death) has been caused by wilful act, negligence, wrongful conduct or breach of any obligation stipulated for the Institution or the Investigator by legal guideline or by this Agreement including all its attachment(s); b) The Institution fails to notify the Sponsor in writing within twenty (20) working days of the dat...
Sample 1
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Poškození zdraví subjektu studie pojištění a odškodnění Zadavatel tímto prohlašuje a potvrzuje, že v souladu s ustanovením § 52 odst. 3 písm. f), zákona o léčivech, v aktuálním platném znění, uzavře pojištění Studie. Zdravotnické zařízení je povinno neprodleně písemně vyrozumět Quintiles a Zadavatele o jakémkoli nároku vztahujícím se k poškození či újmě na zdraví, k nimž skutečně či údajně došlo v souvislosti s nežádoucí reakcí na Hodnocené léčivo, a zavazuje se plně spolupracovat se Zadavatelem při řešení nežádoucí události. Zadavatel uhradí Zdravotnickému zařízení přímé, přiměřené a nezbytné zdravotní výdaje, které vznikly Zdravotnickému zařízení v souvislosti s léčbou jakýchkoli nežádoucích událostí, poškození nebo újmy na zdraví Subjektu studie způsobené léčbou Subjektu studie v souladu s Protokolem, s výjimkou případů, kdy taková nežádoucí událost, poškození nebo újma na zdraví je způsobena (jak určí příslušný soud, pokud se smluvní strany nedohodnou jinak): a) pochybením Zdravotnického zařízení, Zkoušejícího nebo jakéhokoli jejich zaměstnance jednat v souladu s touto Smlouvou, Protokolem, jakoukoli písemnou instrukcí Zadavatele týkající se Studie nebo jakýmikoli Příslušnými právními předpisy nebo prováděcím předpisem nebo postupem, včetně GCP, vydaným
Sample 1
Poškození zdraví subjektu studie. Zadavatel prohlašuje a potvrzuje, že v souladu s ust. § 52 odst. 3, písm. f) zákona č. 378/2007 Sb., o léčivech, v platném znění, zajistí pojištění klinického hodnocení. Zdravotnické zařízení je povinno neprodleně písemně vyrozumět Quintiles a Zadavatele o jakémkoli nároku vztahujícímu se k onemocnění či újmě na zdraví, k nimž skutečně či údajně došlo v souvislosti s nežádoucí reakcí na Hodnocené léčivo a zavazuje se plně spolupracovat se Zadavatelem při řešení nežádoucí události. Zadavatel uhradí Zdravotnickému zařízení přímé, přiměřené a nezbytné zdravotní výdaje, které expenses incurred by Institution for the treatment of any adverse event experienced by, illness of or bodily injury to a Study Subject that is caused by treatment of the Study Subject in accordance with the Protocol, except to the extent that such adverse event, illness or personal injury is caused by: vznikly Zdravotnickému zařízení v souvislosti s léčbou jakýchkoli nežádoucích událostí, nemocí nebo újmy na zdraví Subjektu studie způsobené léčbou Subjektu studie v souladu s Protokolem, s výjimkou případů, kdy taková nežádoucí událost, nemoc nebo újma na zdraví je způsobeno: a) failure by Institution, Investigator or any of their respective personnel to comply with this Agreement, the Protocol, any written instructions of Sponsor concerning the Study, or any applicable law, regulation or guidance, including GCPs, issued by any regulatory authority, or a) pochybením Zdravotnického zařízení, Zkoušejícího nebo jakéhokoliv jejich zaměstnance jednat v souladu s touto Smlouvou, Protokolem, jakoukoliv písemnou instrukcí Zadavatele týkající se Studie, nebo jakéhokoliv platného zákona nebo prováděcího předpisu nebo postupu, včetně GCP, vydaném jakoukoliv regulační autoritou, nebo b) negligence or willful misconduct by Institution, Investigator or any of their respective personnel or b) nedbalostí nebo úmyslným nesprávným jednáním Zdravotnického zařízení, Zkoušejícím nebo jakýmkoliv jejich zástupcem nebo c) failure of the Study Subject to follow the reasonable instructions of the Investigator relating to the requirements of the Study. c) porušením povinnosti Studijním Subjektem jednat v souladu s důvodnými pokyny Zkoušejícího týkajících se požadavků Studie. d) Indemnification by Sponsor is covered in a separate indemnification letter, in accordance with provisions set forth in Attachment B. Sponsor and Quintiles maintain contractual liability coverage with sufficient limits to cover their obligatio...
Sample 1
Poškození zdraví subjektu studie odškodnění, pojištění a náhrada škody Zadavatel prohlašuje a potvrzuje, že v souladu s ust. § 52 odst. 3, písm. f) zákona č. 378/2007 Sb., o léčivech, v platném znění, zajistí pojištění klinického hodnocení. Zdravotnické zařízení je povinno neprodleně písemně vyrozumět IQVIA a Zadavatele o jakémkoli nároku vztahujícímu se k onemocnění či újmě na zdraví, k nimž skutečně či údajně došlo v souvislosti s nežádoucí reakcí na Hodnocené léčivo a zavazuje se plně spolupracovat se Zadavatelem při řešení nežádoucí události. Zadavatel uhradí Zdravotnickému zařízení náklady na bezprostřední zdravotní výdaje na léčbu Subjektu studie, který onemocněl nebo jemuž byla způsobena újma na zdraví jako přímý následek jeho léčby v souladu s ustanoveními Protokolu a této Smlouvy. Zadavatel odškodní Zdravotnické zařízení za veškerou odpovědnost nebo ztrátu vyplývající z rozsudků nebo nároků vzniklých illness, injury or death of a Study Subject as a direct result of treatment of such subject in accordance with the terms of the Protocol and this Agreement except to the extent that such adverse event, illness or personal injury is caused by: a) failure by Institution, Investigator or any of their respective personnel to comply with this Agreement, the Protocol, any written instructions of Sponsor concerning the Study, or any applicable law, regulation or guidance, including GCPs, issued by any regulatory authority, or b) negligence or willful misconduct by Institution, Investigator or any of their respective personnel; or c) failure of the Study Subject to follow the reasonable instructions of the Investigator relating to the requirements of the Study. The Sponsor’s liability to reimburse the Institution under this provision shall not be limited to the amount payable under any insurance required to be carried by Sponsor but shall extend to the full amount of the Institution’s actual damages in the amount of subject’s claim or of subject's legal representative's claim successfully claimed under Czech legal order. Institution shall not be entitled to such reimbursement according to the previous paragraph if: a) The injury of subject (including death) has been caused by willful act, negligence, wrongful conduct or breach of any obligation stipulated for the Institution or the Investigator by legal guideline or by this Agreement including all its appendices; b) The Institution fails to notify the Sponsor or IQVIA in writing within twenty (20) working days of the date z onemocnění, újmy ...
Sample 1
Poškození zdraví subjektu studie. The Site shall promptly notify IQVIA and Sponsor in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and cooperate with Sponsor in the handling of the adverse event. Místo provádení klinického hodnocení je povinno neprodlene písemne vyrozumet IQVIA a Zadavatele o jakémkoli nároku vztahujícímu se k onemocnení či újme na zdraví, k nimž skutečne či údajne došlo v souvislosti s nežádoucí reakcí na Hodnocené léčivo a zavazuje se plne Sponsor shall reimburse Institution for the direct, reasonable and necessary medical expenses incurred by Institution for the treatment of any adverse event experienced by, illness of or bodily injury to a Study Subject that is caused by treatment of the Study Subject in accordance with the Protocol, except to the extent that such adverse event, illness or personal injury is caused by:
Sample 1
Poškození zdraví subjektu studie odškodnění, pojištění a náhrada škody Zadavatel zajistil, že před zahájením Studie bude pro něho jako Zadavatele a Zkoušejícího uzavřeno pojištění odpovědnosti za škodu ve smyslu § 52 odst. 3 písm.
Sample 1
Poškození zdraví subjektu studie. Sponsor hereby represents and warrants that it will provide insurance in accordance with § 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended, which will cover Sponsor’s and Investigator’s liability for damage including liability for death or health damage of a Study Subject resulting out of their participation in the Study. A copy of the Certificate of Insurance is attached hereto as Attachment C. Sponsor is obliged to maintain the above Zadavatel prohlašuje a potvrzuje, že v souladu s ust. § 52 odst. 3, písm. f) zákona č. 378/2007 Sb., o léčivech, v platném znění, zajistí pojištění odpovědnosti za škodu pro zadavatele a zkoušejícího, jehož prostřednictvím je zajištěno i odškodnění v případě smrti subjektu hodnocení nebo v případě škody vzniklé na zdraví subjektu hodnocení v důsledku provádění klinického hodnocení.. Kopie pojistného certifikátu tvoří přílohu C této Smlouvy. Zadavatel je povinen výše uvedené insurance throughout the duration of the Study. Without prejudice to the conditions set forth below, all claims from Study Subjects arising out of health damage or death caused by Study Subject’s participation in the Study, but only if such claims are successfully granted by final decisions of Czech courts, those shall be satisfied by Sponsor. The Site shall promptly notify Quintiles and Sponsor in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and cooperate with Sponsor in the handling of the adverse event. Sponsor shall reimburse Institution for the direct, reasonable and necessary medical expenses incurred by Institution for the treatment of any adverse event experienced by, illness of or bodily injury to a Study Subject that is caused by treatment of the Study Subject in accordance with the Protocol, except to the extent that such adverse event, illness or personal injury is caused by:
Sample 1
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Poškození zdraví subjektu studie. POJIŠTĚNÍ A ODPOVĚDNOST
Sample 1

Related to Poškození zdraví subjektu studie

  • 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Vlastnictví Zdravotnické zařízení si ponechá a bude uchovávat Zdravotní záznamy. Zdravotnické zařízení a Zkoušející převedou na Zadavatele veškerá svá práva, nároky a tituly, včetně práv duševního vlastnictví k Důvěrným informacím (ve smyslu níže uvedeném) a k jakýmkoli jiným Studijním datům a údajům.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • 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.

  • DUŠEVNÍ VLASTNICTVÍ a) The Institution and the Investigator acknowledge and agree that the Sponsor shall have exclusive ownership rights to all Study Data, Study results, information, improvements, developments, discoveries, inventions, work, know-how and other rights (whether or not patentable), created, developed, and/or reduced to practice as a result of or in connection with the conduct of the Study and/or the use of the Study Drug or the Confidential Information, together with all intellectual property rights (existing and future) relating thereto (“Intellectual Property”) conceived by the Institution or the Investigator or Study Personnel, solely or jointly with others as a result of work done under this Agreement, to the widest extent possible under applicable law. The Institution and the Investigator shall promptly disclose in writing to PSI and the Sponsor all Intellectual Property made or reduced to practice by the Institution, the Investigator and/or the Study Personnel related to the Study. At the Sponsor's request, the Institution and the Investigator shall cause all rights titles and interests in and to any such Intellectual Property to be assigned to the Sponsor without additional compensation and provide reasonable assistance to obtain patents, including causing the execution of any invention assignment or other documents. b) All parties to this Agreement and Sponsor shall retain all right, title and interest in any Intellectual Property that was owned by such party or Sponsor prior to or apart from the commencement of this Agreement. No a) Zdravotnické zařízení a Hlavní zkoušející uznávají a souhlasí, že Zadavatel bude mít výhradní vlastnická práva ke všem Studijním údajům, výsledkům Studie, informacím, vylepšením, na vývoj, k objevům, vynálezům, dílům, know-how a dalším právům (ať už patentovatelným či nikoli), vytvořeným, vyvinutým, a/nebo uvedeným do praxe v důsledku nebo v souvislosti s prováděním Studie, a/nebo používáním Studijního léku nebo Důvěrných informací společně s právy duševního vlastnictví (stávajícími i budoucími) s nimi souvisejícími (dále jen „Duševní vlastnictví“), které vytvořilo Zdravotnické zařízení, Hlavní zkoušející nebo Studijní personál, samostatně nebo společně s ostatními jako výsledek práce prováděné na základě této Smlouvy, a to v největším možném rozsahu povoleném příslušnými zákonnými předpisy. Zdravotnické zařízení a Hlavní zkoušející budou neprodleně písemně informovat PSI a Zadavatele o veškerém Duševním vlastnictví vytvořeném nebo uvedeném do praxe Zdravotnickým zařízením, Hlavním zkoušejícím a/nebo Studijním personálem v souvislosti se Studií. Na žádost Zadavatele zajistí Zdravotnické zařízení a Hlavní zkoušející převod veškerých práv a zájmů týkajících se Duševního vlastnictví na Zadavatele bez další odměny a poskytnou přiměřenou součinnost k získání patentu včetně zajištění podpisu dokumentů k převodu objevu nebo jiných dokumentů. b) Všechny strany této Smlouvy a Zadavatel si i nadále ponechají veškerá práva, nároky a podíly na jakémkoli Duševním vlastnictví, které daná strana nebo Zadavatel vlastnili před začátkem platnosti této Smlouvy nebo na které license grant or assignment, express or implied, by estoppel or otherwise, is intended by, or shall be inferred from, this Agreement except to the extent necessary for each party to fulfill its obligations under this Agreement or otherwise give effect to this Agreement.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

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