Institution. Principal Investigator shall promptly disclose and assign to Sponsor all Inventions generated by Institution/Principal Investigator pursuant to this Agreement.
Institution and Investigator hereby acknowledge and agree that each has received sufficient Information regarding their respective participation in the Study. In addition, Investigator further warrants (i) that he/she has distributed all relevant Information to the Study Personnel who have a need to know such Information in order to perform their assigned tasks on the Study, and (ii) that he/she, and all Study Personnel (as applicable), has read and understands such Information.
Institution. Principal Investigator shall during the Study, on reasonable prior written notice and at an agreed upon time, permit authorized personnel of Sponsor to access the site during normal business hours in order to conduct monitoring and audits. Any review by Sponsor of source documents shall be performed with due regard for Study subject confidentiality.
Institution. Principal Investigator shall immediately deliver to Sponsor all Data generated as a direct result of the Study and shall, at Sponsor’s expense return to Sponsor or destroy upon instructions of the Sponsor, all unused Study Product, all documents, materials and equipment provided by Sponsor or CRO and all Sponsor Confidential Information, as defined in Section 3, at the earlier of the conclusion of the Study or termination of this Agreement. This provision does not apply to those documents that should be maintained and retained by Institution/Principal Investigator at Institution, as defined in the Protocol and as requested by applicable laws and regulations.
Institution. Principal Investigator agrees to inform the investigational staff that their personal data may be collected. In such case the Sponsor may transmit such personal data to other affiliates or group companies and their respective agents worldwide. Accordingly, personal data may be transmitted to countries outside the European Economic Area, such as the United States, which the EU has determined currently lack appropriate privacy laws providing an adequate level of privacy protection. Nonetheless, Sponsor will apply adequate privacy safeguards to protect such personal data. Personal data may also be disclosed as required by individual regulatory agencies or applicable law, such as to report serious adverse events.
Institution and Investigator agree that they are not presently under any agreement or obligation which conflicts with the duties and obligations owed to CRO or SPONSOR under this Agreement, and further agree not to undertake any such obligation or agreement during the course of the Study. Investigator warrants that no Study Personnel are presently under any agreement or obligation which conflicts with the duties and obligations owed to SPONSOR or CRO under this Agreement, and shall ensure that no Study Personnel will undertake any such obligation or agreement during the course of the Study.
Institution. Principal Investigator agrees to report to Sponsor immediately but not later than twenty-four (24) hours after learning of any serious adverse events and other important medical events, as identified in the Protocol, affecting any Study subject in the Study. Institution/Principal Investigator further agrees to follow up such report with detailed, written reports in compliance with all applicable legal and regulatory requirements. Institution/Principal Investigator shall record and evaluate all Adverse Events experienced by the Study subjects in accordance with the Protocol.