Common use of INVESTIGATIONAL PRODUCT Clause in Contracts

INVESTIGATIONAL PRODUCT. If the Organisation facilitates the supply to the Institution of any Investigational Product for use in the Study, the Organisation must ensure that all supplied Investigational Product is packaged in safe and appropriately labelled containers. In relation to any Investigational Product supplied by the Organisation, the Institution must: ensure that it is used strictly according to the Protocol and not used for any other purposes, unless agreed in writing by the Organisation; provide a written explanation accounting for any missing Investigational Product; not charge any Study Subject or third party payer for it; keep it under appropriate storage conditions as specified in the Protocol in a secured area accessible only to authorised Personnel; and maintain complete and current records for all received, dispensed and returned Investigational Product. When this Agreement ends, the Institution must promptly return (or destroy if requested by the Organisation, and provide evidence of such destruction) to the Organisation any unused Investigational Product. PROVISION OF EQUIPMENT The Organisation may provide the Institution and Principal Investigator with the Equipment; this will be at no charge. Unless otherwise agreed by the parties in writing, the Equipment will be used only by the Principal Investigator and Personnel involved in the conduct of the Study and only for the purposes of the Study. The Institution will ensure the Principal Investigator and Institution’s Personnel will use the Equipment in accordance with the Equipment's manufacturer's specifications and instructions. The Institution will take reasonable care in the use and secure storage of the Equipment. The parties will cooperate in maintaining the Equipment in good working order and ensuring that it is in a safe condition and compliant with the requirements of the relevant licensing and safety authorities so long as it continues to be used for the purposes of the Study. The parties will share equally any out of pocket expenses in doing so. When this Agreement ends, if requested by the Organisation the Institution must return the Equipment to the Organisation or dispose it in an appropriate manner. If the Organisation makes no such request within 7 days after the Agreement ends, the Institution will be deemed to be the owner of the Equipment and may use it in any manner it wishes. CONFIDENTIALITY AND PRIVACY Subject to clause 9.2, the Parties must not, and must ensure their Personnel do not, use or disclose any Confidential Information, other than where and only to the extent such use or disclosure is necessary for the performance of the Study. The Institution may use or disclose Confidential Information in any of the following circumstances: for the purposes of complying with the Institution’s internal complaint procedures, accident reporting procedures, quality assurance activities, disciplinary procedures or any applicable policy in relation to patient safety, Adverse Events and/or reportable incidents; for the purposes of disclosing any material risks identified during the Study or subsequent to it, to Study Subjects, Principal Investigators, medical practitioners administering treatment to Study Subjects, Responsible HRECs and Regulatory Authorities; for the purposes of complying with the requirements of any Regulatory Authority; for the purposes of the monitoring of the Study by the Responsible HREC; where the Organisation consents in writing to the disclosure; where the Confidential Information has been independently received from a third party who is free to disclose it; where the Confidential Information has entered the public domain other than as a result of a breach of this Agreement; as part of a publication issued under the provisions of clause 11; where release of the Confidential Information is required by law, with notice as soon as reasonably practical to the Organisation; for the purposes of legal advice; and disclosure to the Institution’s insurer. Where Confidential Information is disclosed in accordance with clause 9.2(1) or 9.2(4), the Confidential Information must only be used in connection with the legitimate purposes of the Institution, and only disclosed to those who have a need to know it for such purposes and are obligated to keep the information confidential. The parties are responsible for ensuring that their Personnel are aware of the obligations in respect of Confidential Information in this clause 9, and are bound in similar terms to keep such information confidential, but are not responsible if those Personnel deliberately and intentionally fail to observe those restrictions. The parties must ensure that any Personal Information arising from the Study regarding Study Subjects or Personnel, is collected, stored, used and disclosed in accordance with the Relevant Privacy Laws.

INVESTIGATIONAL PRODUCT. If the Organisation Principal Investigator facilitates the supply to the Institution of any Investigational Product for use in the Study, the Organisation Principal Investigator must ensure that all supplied Investigational Product is packaged in safe and appropriately labelled containers. In relation to any Investigational Product supplied by the OrganisationPrincipal Investigator, the Institution must: ensure that it is used strictly according to the Protocol and not used for any other purposes, unless agreed in writing by the OrganisationPrincipal Investigator; provide a written explanation accounting for any missing Investigational Product; not charge any Study Subject Participant or third party payer for it; keep it under appropriate storage conditions as (including any conditions specified in the Protocol Protocol) and in a secured area accessible only to authorised Personnel; and maintain complete and current records for all received, dispensed and returned Investigational Product. When this Agreement ends, the Institution must promptly return (or destroy if requested by the OrganisationPrincipal Investigator, and provide evidence of such destruction) to the Organisation Principal Investigator any unused Investigational Product. PROVISION OF EQUIPMENT The Organisation may provide the Institution Confidentiality and Principal Investigator with the Equipment; this will be at no charge. Unless otherwise agreed by the parties in writing, the Equipment will be used only by the Principal Investigator and Personnel involved in the conduct of the Study and only for the purposes of the Study. The Institution will ensure the Principal Investigator and Institution’s Personnel will use the Equipment in accordance with the Equipment's manufacturer's specifications and instructions. The Institution will take reasonable care in the use and secure storage of the Equipment. The parties will cooperate in maintaining the Equipment in good working order and ensuring that it is in a safe condition and compliant with the requirements of the relevant licensing and safety authorities so long as it continues to be used for the purposes of the Study. The parties will share equally any out of pocket expenses in doing so. When this Agreement ends, if requested by the Organisation the Institution must return the Equipment to the Organisation or dispose it in an appropriate manner. If the Organisation makes no such request within 7 days after the Agreement ends, the Institution will be deemed to be the owner of the Equipment and may use it in any manner it wishes. CONFIDENTIALITY AND PRIVACY Privacy Subject to clause 9.210.2, the Parties must each not, and must each use reasonable endeavours to ensure their Personnel do not, use or disclose any Confidential Information, other than where and only to the extent such use or disclosure is necessary for the performance of the Study. The Institution and the Principal Investigator may each use or disclose Confidential Information in any of the following circumstances: for the purposes of complying with the Institution’s internal complaint procedures, accident reporting procedures, quality assurance activities, disciplinary procedures or any applicable policy in relation to patient safety, Adverse Events and/or reportable incidentsincidents of each; for the purposes of disclosing any material risks identified during the Study or subsequent to it, to Study Subjects, Principal InvestigatorsParticipants, medical practitioners administering treatment to Study SubjectsParticipants, Responsible Reviewing HRECs and Regulatory Authorities; for the purposes of complying with the requirements of any Regulatory Authority; for the purposes of the monitoring of the Study by the Responsible Reviewing HREC; where the Organisation other party consents in writing to the disclosure; where the Confidential Information has been independently received from a third party who is free to disclose it; where the Confidential Information has entered the public domain other than as a result of a breach of this Agreement; as part of a publication issued under the provisions of clause 11; where release of the Confidential Information is required by law, with notice as soon as reasonably practical to the Organisation; for the purposes of legal advice; and disclosure to the Institution’s insurer. Where Confidential Information is disclosed in accordance with clause 9.2(1) or 9.2(4), the Confidential Information must only be used in connection with the legitimate purposes of the Institution, and only disclosed to those who have a need to know it for such purposes and are obligated to keep the information confidential. The parties are responsible for ensuring that their Personnel are aware of the obligations in respect of Confidential Information in this clause 9, and are bound in similar terms to keep such information confidential, but are not responsible if those Personnel deliberately and intentionally fail to observe those restrictions. The parties must ensure that any Personal Information arising from the Study regarding Study Subjects or Personnel, is collected, stored, used and disclosed in accordance with the Relevant Privacy Laws.;