Institution and Principal. Investigator each shall conduct and require, subinvestigator(s), and Institution’s other employees, subcontractors and agents performing services related to the Study (collectively, “Institution Personnel”) to conduct the Study in accordance with: (i) this Agreement; (ii) the Protocol; (iii) all written instruction provided by or on behalf of AbbVie; and (iv) all applicable laws and regulations and industry codes of practice (collectively “Law(s)”), including without limitation, anti-bribery and anti-corruption laws, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E6 Good Clinical Practice (“ICH-GCP”), the Act on Pharmaceuticals No. 378/2007 Sb., as amended (“Act on Pharmaceuticals”), the Act on Health Care Services No. 372/2011 Sb., as amended (“Health Care Services Law”), Decree No. 226/2008 Sb., as amended, on Good Clinical Practice and Detailed Conditions of Clinical Trials on Medicinal Products, Decree No. 84/2008 Sb. on Good Pharmacy Practice, as amended (“Good Pharmacy Practice”), Decree No. 86/2008 Sb. on Good Laboratory Practice in the Area of Medicines, Act No. 110/2019 Sb. on Processing of Personal Data, the EU General Data Protection Regulation (2016/679) and related data protection laws (“Data Protection Law(s)”) and other data protection and privacy laws, as each may be amended, from time to time. In furtherance of the foregoing obligations, AbbVie shall ensure that the State Institute for Drug Control (“SUKL“) and an Ethics Committee (“EC”) established and constituted in accordance with applicable Laws approves and oversees the conduct of the Study. AbbVie shall notify SUKL and EC of (i) the date and place of commencement of the Study within sixty (60) days from its start in the Czech Republic and (ii) the introduction of substantial amendments to the Protocol as required by applicable regulations. Institution and Principal Investigator shall observe the procedures set forth for recording and reporting data as required by applicable regulations. a. Zdravotnické zařízení a Hlavní zkoušející budou provádět Studii v souladu s následujícími ustanoveními, jejichž dodržení budou vyžadovat i na dalších zkoušejících a dalších zaměstnancích, subdodavatelích a zástupcích Zdravotnického zařízení spojených se Studií (společně „Personál zdravotnického zařízení“). Studie se bude provádět v souladu s (i) touto Smlouvou, (ii) Protokolem, (iii) všemi písemnými pokyny poskytnutými společností AbbVie nebo jejím jménem; a
Appears in 3 contracts
Sources: Clinical Study Agreement, Clinical Study Agreement, Clinical Study Agreement