Common use of The Study Clause in Contracts

The Study. 1The Parties shall comply, and conduct the Study in accordance, with the Protocol, the terms and conditions imposed by the IRB (if any), the terms and conditions set forth in this Agreement, as well as the following: the ICH GCP; the ethical principles of the Declaration of Helsinki; any and all orders and mandates of the Regulatory Authorities; all laws, rules, regulations, guidance and guidelines applicable to the conduct of the Study as applicable in the respective jurisdictions of the Parties including, but not limited to all applicable Singapore laws, guidance, guidelines and regulations governing the conduct of clinical studies, and the Protocol. For the avoidance of doubt, the Institution shall comply only with Singapore laws, rules, regulations, guidance, and guidelines; and any Study-related instructions given by the Sponsor, any of its Affiliates or a third party authorised by the Sponsor. any and all orders and mandates of the relevant authorities and IRB and/or ethic committees. ((a) to (f) collectively referred to as “Applicable Laws”.) The Study shall not commence until: all the necessary approvals of the relevant Regulatory Authority(ies) and the IRB have been obtained in writing by the Sponsor and the Institution; the written approval of relevant authority(ies) or organisation that owns or is responsible for the administration of the Study Site has been obtained, if such authority or organisation is not the Institution; and the Informed Consent Form as provided by the Sponsor, has been approved by the IRB and the relevant Regulatory Authority(ies).