Conduct of Trial. The Institution and the Investigator shall conduct the Trial in accordance with the Protocol, the opinion of the ethics committee(s), this Agreement and any additional reasonable requirements notified by Biogen to the Investigator. The Investigator and the Institution acknowledge that Biogen, and its affiliates need to adhere to the provisions of (i) the Xxxxxxx Xxx 0000 of the United Kingdom (Bribery Act); (ii) the Foreign Corrupt Practices Xxx 0000 of the United States of America (FCPA) and (iii) any other applicable anti-corruption legislation (together the Applicable Anti-Corruption Legislation). A summary of the key principles underlying the Bribery Act and the FCPA is set out in Schedule C. The Institution and the Investigator shall not and shall not permit or induce employees, agents, consultants or other representatives, whether directly or indirectly, to engage in any activity that is prohibited by the Applicable Anti-Corruption Legislation including bribery, kickbacks, payoffs or other corrupt business practices. Furthermore, the Institution and the Investigator shall conduct the Trial in accordance with all national and supranational legislation, regulations and guidance notes relevant to the jurisdiction in which the Trial is being conducted, including, but not limited to:
Conduct of Trial. The Institution and the Investigator shall conduct the Trial in accordance with the Protocol, the opinion of the ethics committee(s), this Agreement and any additional reasonable requirements notified by Biogen to the Investigator. The Investigator and the Institution acknowledge that Biogen, and its affiliates need to adhere to the provisions of (i) the Xxxxxxx Xxx 0000 of the United Kingdom (“Bribery Act”); (ii) the Foreign Corrupt Practices Xxx 0000 of the United States of America (“FCPA”) and (iii) any other applicable anti-corruption legislation (together the “Applicable Anti-Corruption Legislation”). A summary of the key principles underlying the Bribery Act and the FCPA is set out in Schedule C. The Institution and the Investigator shall not and shall not permit or induce employees, agents, consultants or other representatives, whether directly or indirectly, to engage in any activity that is prohibited by the Applicable Anti- Corruption Legislation including bribery, kickbacks, payoffs or other corrupt business practices. Furthermore, the Institution and the Investigator shall conduct the Trial in accordance with all national and supranational legislation, regulations and guidance notes relevant to the jurisdiction in which the Trial is being conducted, including, but not limited to: (e) Provádění Klinického hodnocení. Zdravotnické zařízení a Zkoušející budou Klinické hodnocení provádět v souladu s Protokolem, stanoviskem etické komise (komisí), touto smlouvou a jakýmikoliv dalšími odůvodněnými požadavky, které společnost Biogen oznámí Zkoušejícímu. Zkoušející a Zdravotnické zařízení berou na vědomí, že společnost Biogen a její přidružené osoby musejí dodržovat ustanovení (i) Zákona Spojeného království Velké Británie a Severního Xxxxx x xxxxxxxxxxxx x xxxx 0000 (xxxx jen „Zákon o úplatkářství“), (ii) Zákona Spojených států amerických o zahraničních korupčních praktikách z roku 1977 (dále jen „FCPA“) a (iii) jakékoliv další příslušné protikorupční legislativy (společně dále jen „Příslušná protikorupční legislativa“). Stručný přehled základních principů Zákona o úplatkářství a FCPA je uveden v Příloze C. Zdravotnické zařízení a Zkoušející nesmějí umožnit nebo nabádat zaměstnance, zprostředkovatele, konzultanty nebo jiné zástupce, ať již přímo či nepřímo, aby se podíleli na jakékoliv činnosti, která je dle Příslušné protikorupční legislativy zakázána, včetně poskytnutí úplatku, provize či jakýchkoliv jiných korupčních praktik. Zdravotnické zařízení a...
Conduct of Trial. Institution shall, and shall cause Principal Investigator and all Institution Personnel to, diligently perform the Trial in accordance with (i) the Protocol, (ii) Applicable Law, (iii) Sponsor’s or its designee’s written instructions and (iv) Institution’s internal policies (which policies Institution represents and warrants are not inconsistent with any of the foregoing). For purposes of this Agreement, “Applicable Law” shall mean all applicable laws, rules, and regulations pertaining to the activities contemplated herein, including without limitation, Directive 2001/20/EC, as implemented in the Czech Republic and as replaced by the CTR as soon as applicable, and Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (“GDPR”) as well as, to the extent not incompatible with the foregoing, all relevant International Conference on Harmonization Good Clinical Practice (“ICH GCP”) guidelines and standards and the World Medical Association Declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects”. 2.1
Conduct of Trial. 3.1 During the course of the Trial and during the remainder of the Research Period, Velindre will answer all reasonable questions and queries put by Bioerivision concerning the Trial.
Conduct of Trial. The Institution and the Investigator shall conduct the Trial in accordance with the Protocol, the applicable legal regulations of Czech Republic the opinion of the ethics committee(s), State Institute of Drug Control, this Agreement and any additional reasonable requirements notified by Biogen to the Investigator. The Investigator and the Institution acknowledge that Biogen, and its affiliates need to adhere to the provisions of (i) the Xxxxxxx Xxx 0000 of the United Kingdom (Bribery Act); (ii) the Foreign Corrupt Practices Xxx 0000 of the United States of America (FCPA) and (iii) any other applicable anti- corruption legislation (together the Applicable Anti-Corruption Legislation). A summary of the key principles underlying the Bribery Act and the FCPA is set out in Schedule C. The Institution and the Investigator shall not and shall not permit or induce employees, agents, consultants or other representatives, whether directly or indirectly, to engage in any activity that is prohibited by the Applicable Anti- Corruption Legislation including bribery, kickbacks, payoffs or other corrupt business practices. Furthermore, the Institution and the Investigator shall conduct the Trial in accordance with all national and supranational legislation, regulations and guidance notes relevant to the jurisdiction in the country in which the Trial is being conducted, including, but not limited to:
Conduct of Trial. The Institution and the Investigator shall conduct the Trial in accordance with the Protocol, the opinion of the ethics committee(s), this Agreement and any additional reasonable requirements notified by Biogen to the Investigator. The Investigator and the Institution acknowledge that Biogen, and its affiliates need to adhere to the provisions of (i) the Xxxxxxx Xxx 0000 of the United Kingdom (Bribery Act); (ii) the Foreign Corrupt Practices Xxx 0000 of the United States of America (FCPA) and (iii) any other applicable anti- corruption legislation (together the Applicable Anti-Corruption Legislation). A summary of the key principles underlying the Bribery Act and the FCPA is set out in Schedule C. The Institution and the Investigator shall not and shall not permit or induce employees, agents, consultants or other representatives, whether directly or indirectly, to engage in any activity that is prohibited by the Applicable Anti- Corruption Legislation including bribery, kickbacks, payoffs or other corrupt business practices. Furthermore, the Institution, Biogen, and the Investigator shall conduct the Trial in accordance with all national and supranational legislation, regulations and guidance notes relevant to the jurisdiction in which the Trial is a nadnárodní legislativou, předpisy a pravidly platnými pro právní řád, ve které Klinické hodnocení probíhá, a to zejména s následujícím: being conducted, including, but not limited to:
Conduct of Trial. The Institution shall ensure that the Trial is conducted in accordance with the Protocol, the opinion of the ethics committee(s), this Agreement and any additional reasonable requirements notified by Biogen to the Institution. The Institution acknowledges that Biogen, and its affiliates need to adhere to the provisions of (i) the Xxxxxxx Xxx 0000 of the United Kingdom (Bribery Act); (ii) the Foreign Corrupt Practices Act 1977of the United States of America (FCPA) and (iii) any other applicable anti-corruption legislation (together the Applicable Anti-Corruption Legislation). A summary of the key principles underlying the Bribery Act and the FCPA is set out in Schedule B. The Institution and the Investigator shall not and shall not permit or induce employees, agents, consultants or other representatives, whether directly or indirectly, to engage in any activity that is prohibited by the Applicable Anti-Corruption Legislation including bribery, kickbacks, payoffs or other corrupt business practices. Furthermore, the Institution shall conduct the Trial in accordance with all national and supranational legislation, regulations and guidance notes relevant to the jurisdiction in which the Trial is being conducted, including, but not limited to:
Conduct of Trial. The Institution shall ensure that the Trial is conducted in accordance with the Protocol, the opinion of the ethics committee(s), this Agreement and any additional reasonable requirements notified by Biogen to the Institution. The Institution acknowledges that Biogen, and its affiliates need to adhere to the provisions of (i) the Xxxxxxx Xxx 0000 of the United Kingdom (“Bribery Act”); (ii) the Foreign Corrupt Practices Act 1977of the United States of America (“FCPA”) and (iii) any other applicable anti-corruption legislation (together the “Applicable Anti-Corruption Legislation”). A summary of the key principles underlying the Bribery Act and the FCPA is set out in Schedule B. The Institution and the Investigator shall not and shall not permit or induce employees, agents, consultants or other representatives, whether directly or indirectly, to engage in any activity that is prohibited by the Applicable Anti-Corruption Legislation including bribery, kickbacks, payoffs or other corrupt business practices. Furthermore, the Institution shall conduct the Trial in accordance with all national and supranational legislation, regulations and guidance včetně poskytnutí úplatku, provize či jakýchkoliv jiných korupčních praktik. Zdravotnické zařízení bude dále provádět Klinické hodnocení v souladu s veškerou národní a nadnárodní legislativou, předpisy a pravidly platnými pro právní řád, ve které Klinické hodnocení probíhá, a to zejména s následujícím: notes relevant to the jurisdiction in which the Trial is being conducted, including, but not limited to:
Conduct of Trial. The Institution shall ensure that the Trial is conducted in accordance with the Protocol, the opinion of the ethics committee(s), this Agreement and any additional reasonable written requirements notified by Biogen to the Institution. The Institution acknowledges that Biogen, and its affiliates need to adhere to all applicable anti bribery rules as summarized under Schedule B (the Applicable Anti-Corruption Legislation). No party to this Agreement, nor its representatives shall or shall permit or induce employees, agents, consultants or other representatives, whether directly or indirectly, to engage in any activity that is prohibited by the Applicable Anti-Corruption Legislation (to the extent it does not contravene the governing provisions of Czech Republic law), including bribery, kickbacks, payoffs or other corrupt business practices. Furthermore, the Institution shall conduct the Trial in accordance with all national and supranational legislation, regulations and guidance notes relevant to the jurisdiction in which the Trial is being conducted, including, but not limited to:
Conduct of Trial. The Institution should ensure Principal Investigator shall conduct the Trial in a professional manner using all due skill, care and diligence. The Institution and Principal Investigator shall inform all persons assisting in the Trial about the Protocol, the Sponsor Drug and their respective obligations relating to the Trial and shall have adequate equipment for the conduct of the Trial. Institution and Principal Investigator shall ensure that the Trial commences only after approval by Sponsor. 1.3
