Confidentiality and Data Protection. 7.1 Each of Investigator and Institution shall not: (i) use Confidential Information for any purpose other than the performance of the Clinical Trial, aggregate and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; or (ii) disclose Confidential Information to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Confidential Information to only those Study Personnel and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive Confidential Information of the confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the informed consent process. 7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information. 7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests under this Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement. (i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential. (ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law. (iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft. (iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information. (v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document. (vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information. (vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution. (viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach. (ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction. 7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwise. 7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 4 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Confidentiality and Data Protection. 7.1 Each The terms of Investigator this Agreement are confidential, and Institution the VENDOR agree to not disclose their terms described herein to any party (other than the VENDOR’s employees, parent companies and shareholders on a need to-know basis only after undertaking reasonable precautions to preserve the confidentiality of the information made available to such individuals) VENDOR agrees that it shall not: (inot at any time during the Term and for a period of Five ( 5 ) use Confidential Information years thereafter Disclose to any person any confidential information not known or available to the general public, outside of this agreement concerning the business, affairs, customer, clients or other Vendors of the Company, including information relating to the operations, processes, plans, pricing, product information, know-how, designs, trade secrets, Intellectual Property, software, market opportunities, customers, Purchase Orders, and the Company requirements. The said information shall not be used by the Vendor for any purpose other than for the performance of the Clinical Trial, aggregate and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; or (ii) disclose Confidential Information to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Confidential Information to only those Study Personnel and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive Confidential Information of the confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests obligations under this Agreement. Vendor agrees that the unauthorized disclosure or use of such Information would cause irreparable harm and significant injury, the degree of which may be difficult to ascertain. Any Confidential Information retained in computer backups breach of this confidentiality provision by the VENDOR shall be maintained considered a material breach of this agreement and will result in accordance with irreparable and continuing damage to the COMPANY for which there will be no adequate remedy at law. Accordingly, Vendor agrees that the Company shall have the right to obtain an immediate injunction from any court of competent jurisdiction enjoining breach of this Agreement.
(i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Agreement and/or disclosure of the Confidential Information. This information is required Company shall also have the right to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or pursue any other third party, except as explicitly provided rights or remedies available at law or equity for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use i. Those maintained by VENDOR for its own information of the Clinical Trial Participant Personal Information and shall at no cost return it to Institutioninformation of its customers of a similar nature, including any copiesor, or shall destroy it in a manner designated by Institution with proof of destruction.if more rigorous, and
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol. Accepted business practices, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to applicable laws. If the extent the REB-approved Protocol COMPANY International, and informed consent permits its sole discretion, requests or requires otherwiseVendor to access any electronic database or online webpage system owned and / or operated by Laktree International, Vendor hereby agrees it shall submit to, and successfully complete Laktree International’s screening and / or testing requirements regarding the protection of online or electronic data.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: Vendor Agreement
Confidentiality and Data Protection. 7.1 The recipient of Confidential Information (“Recipient”) shall take care to prevent the publication and distribution of the Confidential Information with at least the same degree of care which the Recipient takes to protect its own confidential information of a similar nature, but in any case no less than an appropriate and reasonable degree of care.
7.2 Each of Investigator and Institution shall notparty may disclose the other party’s Confidential Information: (i) use to its affiliates, employees, officers, representatives or advisers, subcontractors, financial institutions involved and correspondent banks who need to know such information for the purposes of carrying out our or your (as applicable) obligations under this Agreement; and (ii) to such extent as may be required by law, a court of competent jurisdiction or any governmental or regulatory authority. In addition, we may disclose – and you hereby explicitly agrees thereto - your Confidential Information for any purpose other than the performance of the Clinical Trial, aggregate and de- identified (as including – but not limited to Sponsor and Clinical Trial- your KYC information) metric reporting to third partiesparty solution providers to perform customer due diligence checks and ongoing monitoring activities in accordance with applicable laws and internal policies. Each party shall ensure that the persons to whom it discloses the other party's Confidential Information comply with this clause.
7.3 Following the termination of this Agreement, and for internal training subject to the Agreement and quality assurance purposesapplicable law, the Recipient agrees either to: (i) return all Confidential Information in tangible form, promptly and by secure means; or (ii) disclose destroy all Confidential Information promptly and by secure means and to certify such destruction in writing. In either case, the Recipient agrees not to retain any third partycopies, except as permitted by this Section and Section 9 (Publication Rights)summaries, as required by Applicable Law extracts or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination other reproductions of Confidential Information to only those Study Personnel and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive Confidential Information of the confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution in whole or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedyin part, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry fulfil its regulatory obligations. The obligations of this Agreement clause will remain in full force and effect until three (3) years after the termination or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy expiration of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests under this Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement.
(i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial 7.4 We undertake that we shall process personal data in accordance with applicable data protection laws and Sponsor [insert if applicable: handle such personal data with care and CRO] in a confidential manner. We shall treat all Clinical Trial Participant Personal Information it may come use the personal data only to the extent necessary for performance of our obligations under this Agreement or applicable laws and we shall not reproduce, duplicate, copy, sell, resell or exploit for any commercial purposes, any data of you or your beneficiaries. We shall have in contact with as confidential.
(ii) Sponsor [insert if applicable: place appropriate technical and CRO] shall comply with the applicable requirements organisational measures which ensure an appropriate level of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly security for the purposes processing of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destructionpersonal data.
7.5 With You shall act as data controller in respect to of any biological materials to be transferred to Sponsor collection, use and processing of your or any Sponsor-designated representative your beneficiaries’ data, and assume full and sole responsibility for testing or analysesthe lawful collection, as required by the Protocol delivery and permitted by Clinical Trial Participants’ informed consents, use of all such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used data for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocolprovision of Services, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with undertaking of transactions via the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwiseOnline Interface.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: General Terms and Conditions
Confidentiality and Data Protection. 7.1 14.1 Each party agrees that they may disclose to the other party (“Receiving Party”), during the course of Investigator and Institution shall not: this Agreement, business or technical information of a confidential nature (i“Confidential Information”) use to the disclosing party (“Disclosing Party”). Confidential Information includes, without limitation, employee data, financial information not otherwise disclosed to the public, patent and patent applications, trade secrets, copyrighted information and other intellectual property, business and marketing plans, the identity of customers and suppliers, future products, product developments and other proprietary information. Any written document or other tangible material will be appropriately marked by the Disclosing Party to indicate whether it contains Confidential Information; however, information in the form of data transmitted electronically which falls within the list of examples above need not be appropriately marked to be Confidential Information and shall be protected pursuant to this provision. Except for data transmitted electronically as provided above, at the time of disclosure, the Disclosing Party will inform the Receiving Party about the confidential nature of any purpose Confidential Information that is not in a written document or other than tangible material form. Each party agrees not to use or disclose the performance Confidential Information of the Clinical Trialother party for its own benefit, aggregate and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and or for internal training and quality assurance purposes; or (ii) disclose Confidential Information to the benefit of any third party, except as permitted by may be required in their performance under this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization Agreement. The Confidential Information shall not be unreasonably withheld. To protect Confidential Informationtreated as confidential, Investigator and Institution shalleven if it is designated as such by the Disclosing Party if: (i) limit dissemination it is or becomes available to the public without confidentiality restrictions through no unauthorized act of Confidential Information to only those Study Personnel and other personnel having a "need to know"the Receiving Party; (ii) advise all Study Personnel and other personnel is received from a third party who receive is not under an obligation of confidence to the Disclosing Party; or iii) is independently developed by employees or contractors of the Receiving Party who did not use the Confidential Information of the confidential nature other party in the development. A Party shall not be in breach of this provision if it is required to disclose Confidential Information pursuant to a requirement of a governmental agency or law, provided such Party gives prompt notice to the Disclosing Party of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator obligation to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any such Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy This Agreement is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for of the Confidential Informationparties.
7.3 Upon expiry 14.2 All of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting a party] at any time, Institution ’s Confidential Information is the exclusive property of such party and Investigator shall return to [choose Sponsor or CRO to match contracting the furnishing of the such party]’s Confidential Information to, or destroyaccess to such items by, at [choose Sponsor the other party and/or its subcontractors will not grant any express or CRO implied license to match contracting party]'s option and expense, all Confidential Information or interest in such other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of party and/or its subcontractors relating to such Confidential Information in except as required to perform the services pursuant to this Agreement. Upon request by a secure location for archival purposes the disclosing party at any time and ongoing compliance from time to time and without regard to the default status of the Parties under this Agreement, and thereafter make no use of the receiving party and/or its subcontractors shall promptly deliver to the disclosing party its Confidential Information whatsoeverin such format as specified by the disclosing party.
14.3 All right, other than title and interest in and to protect property, data (including personal data), information, equipment, supplies and materials provided by Customer or its rights affiliates (the “Customer Materials”) shall remain at all times vested in Customer or its affiliates, and interests under this Agreement. Any Confidential Information retained in computer backups nothing contained herein shall be maintained deemed in accordance with this Agreement.
(i) Where applicableany way to transfer any ownership or other interest therein to Yorktel. Customer grants to Yorktel a non-exclusive, Sponsor [insert if applicable: or CRO] may have access limited, fully paid license during the Term to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with use the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and Customer data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the sole purpose of the Clinical Trial performing Services for which the biological materials were collected and Customer in accordance with the informed consentsterms and conditions of this Agreement and any SOW.
14.4 All right, REB-approved Protocoltitle and interest in and to property, data, information, equipment, supplies and materials provided by Yorktel in the performance of the Services shall remain at all times vested in Yorktel, and Applicable Lawnothing contained herein shall be deemed in any way to transfer any ownership or other interest therein to Customer. Yorktel grants Customer a non-exclusive, including privacy limited, fully paid license during the Term to use the Yorktel furnished data, software or IP for the sole purpose of utilizing the Services in accordance with the terms and conditions of this Agreement and any SOW
14.5 While in possession of Customer data, Yorktel shall use said data protection laws. Sponsor only for the intended purpose and to the extent necessary for the proper performance of the Contract and shall not make process the data for any attempt other purpose. Data will be treated as Customer confidential in accordance with Yorktel’s Customer Data Privacy Policy (xxxx://xxx.xxxxxxx.xxx/privacy-policy/) and secured in accordance with Yorktel’s ISO27001 procedures. Yorktel is Privacy Shield Certified. By acceptance of these terms and conditions customer agrees that Yorktel can store EU customer data in the US. Our Privacy Shield certification status grants Yorktel the legal basis to re-identify Clinical Trial Participants with store the biological materials or contact any such Clinical Trial ParticipantsEU customer's data in the US. Sponsor shall require any Sponsor-designated representative receiving biological materials to Evidence of certification can be found at xxxxx://xxx.xxxxxxxxxxxxx.xxx/participant?id=a2zt0000000PDMCAA4&status=Active. Yorktel and Customer will comply with all Applicable Law Data Protection legislation as applicable, including but not limited to the EU General Data Protection Regulation (GDPR). With Customer permission, Yorktel may use customer data to conduct user satisfaction surveys. Each party agrees to obtain all necessary consents under applicable data protection and privacy laws and will not pass personal data to the other party or to third parties without prior notification to the data subject. Each party agrees to obtain all necessary consents under applicable data protection and privacy laws and will not pass personal data to the other party or to third parties without prior notification to the data subject. By acceptance of these terms and conditions, the Customer (Data Controller) acknowledges and authorizes Yorktel subcontractors to be sub-processors of this Agreement applicable to such biological materials, Customer Data only for the intended purpose and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent necessary for the REB-approved Protocol proper performance of the SOW and informed consent permits or requires otherwiseshall not process the data for any other purpose.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: Procurement Agreement
Confidentiality and Data Protection. 7.1 Each Confidentiality In return for the disclosure by each Party of Investigator and Institution shall not: (i) use Confidential Information and for any purpose other than consideration given under this Agreement, each Supplier shall (except as expressly permitted by this Agreement or with the performance written consent of the Clinical TrialDisclosing Party): keep all Confidential Information secret; only use or make copies of Confidential Information in connection with and to the extent necessary for the purposes of this Agreement and the relevant Tower Services Agreement or Supply Agreement(s); take all reasonable action to ensure that, aggregate and de- identified (as within its organisation, the Confidential Information is not made available to Sponsor and Clinical Trial) metric reporting any person who is not an Authorised Person; use all reasonable endeavours to third partiesensure that Confidential Information within its control is kept securely protected against theft or unauthorised access, and for internal training in any event shall maintain its security, integrity and quality assurance purposesconfidentiality to at least the same standard as it applies to its own confidential information; and not reverse engineer, or (ii) attempt to reverse engineer, any software comprised within the Confidential Information, except to the extent permitted by law. A Supplier may disclose Confidential Information to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Confidential Information to only those Study Personnel and other personnel having Authorised Persons on a "need need-to-know" basis solely in relation to know"; (ii) advise this Agreement, provided that the Supplier: informs all Study Personnel and other personnel who receive Confidential Information of the confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so Authorised Persons that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required confidential; and ensures that all Authorised Persons (other than those already under a professional duty of confidence to be disclosedthat Supplier or an obligation of confidence as part of employment arrangements) enter into written confidentiality undertakings with it on equivalent terms to this Clause 28, and shall request confidential treatment for provide copies of such undertakings to the Confidential Information.
7.3 Upon expiry of other Supplier to this Agreement upon that other Supplier's reasonable request; and shall be responsible for all acts and omissions of Authorised Persons as though they were its own acts or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests omissions under this Agreement. Any Confidential Information retained in computer backups Each Supplier shall be maintained in accordance with this Agreement.
(i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with promptly notify the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing Disclosing Party if it becomes aware of a privacy, confidentiality any unauthorised use or security breach relating to Personal disclosure by any Authorised Person or any other person of any Confidential Information. A Supplier may disclose any Confidential Information to any regulator, law enforcement agency or other third party if it is required to do so by law, regulation, or similar authority. In those circumstances: that Supplier shall (provided that it is practical and lawful to do so) notify the event of a breach, Sponsor Disclosing Party in writing as soon as practicable before the disclosure; the relevant Supplier and the Disclosing Party shall use all reasonable endeavours to consult with Institution each other with a view to agreeing the timing, manner and Investigator to identify the root cause extent of the breach disclosure; and the affected informationSupplier required to disclose shall in any event use all reasonable endeavours to obtain written confidentiality undertakings in its favour from the third party. If the Supplier required to disclose is unable to inform the Disclosing Party before Confidential Information is disclosed, it shall (provided that it is lawful to undertake do so) fully inform the other immediately afterwards in writing of the circumstances of the disclosure and implement possible mitigation measuresthe Confidential Information which has been disclosed. Nothing in this Agreement or the disclosures envisaged by this Clause shall (except as expressly agreed otherwise) operate to transfer, or operate as a grant of any licences to the party to which the Confidential Information is being disclosed pursuant to Clause 28.4, of any Intellectual Property Rights in the information being disclosed. The undertakings and to determine appropriate measures to prevent the recurrence other provisions of such a breach.
(ix) Upon expiry or this Clause 28 shall continue in force without limit in time and shall survive termination of this Agreement, or upon request, Sponsor but shall cease any and all use to apply to information which may enter the public domain otherwise than through the unauthorised disclosure by or fault of the Clinical Trial Participant Personal recipient of the Confidential Information and or by a person with whom such recipient is connected in any way. Each Supplier acknowledges that damages alone would not be an adequate remedy in the event of breach by the other Party of the provisions of this Clause. Accordingly, it is agreed that any Party shall at no cost return it to Institutionbe entitled, including any copies, or shall destroy it in a manner designated by Institution with without proof of destruction.
7.5 With respect special damages, to seek an injunction or other interim remedy for any threatened or actual breach of this Clause, without prejudice to any biological materials other rights and remedies which that Party may have. Data Protection Each Supplier's attention is drawn to be transferred the Data Protection Xxx 0000, Directives 95/46/EC and 00/31/EC of the European Parliament and any legislation and/or regulations implementing them (all referred to Sponsor together as the "Data Protection Requirements"). Each Supplier warrants that they will duly observe all their obligations under the Data Protection Requirements that arise in connection with this Agreement. In particular, a Supplier (the "Data Processor") shall, in relation to the processing of another Supplier's (the "Data Controller") personal data: only carry out processing on the Data Controller's instructions; implement appropriate technical and organisational measures to protect personal data against accidental or any Sponsor-designated representative for testing unlawful destruction or analysesaccidental loss, as required by the Protocol and permitted by Clinical Trial Participants’ informed consentsalteration, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited unauthorised disclosure or access; and (iii) only be used for take reasonable steps to ensure the purpose reliability of staff that have access to personal data. The Suppliers shall not transfer any personal data received from any other Party outside of the Clinical Trial for which EEA without the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach prior written consent of the foregoing by any of its representatives. Sponsor acknowledges other Party that is the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwiseData Controller.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: Collaboration Agreement
Confidentiality and Data Protection. 7.1 Each In the performance of Investigator this Agreement, the Parties may have access to information that may include information, data or materials relating to a Party’s products and Institution services, technology, business plans, prices, financial information, marketing plans, and other trade secret or proprietary information that a party either designates as confidential, or should be reasonably understood given the nature of the information to be confidential (“Confidential Information”). The Party disclosing such information under this Agreement is referred to as “Disclosing Party” and the Party receiving such information is referred to as the “Receiving Party.” Receiving Party agrees, with respect to such Confidential Information to: (i) use such Confidential Information only for the purposes of carrying out its obligations pursuant to this Agreement; (ii) to use the same methods and degree of care to prevent disclosure of such Confidential Information as it uses to prevent disclosure of its own proprietary and Confidential Information but in no event less than reasonable care; and (iii) to disclose Confidential Information to its employees and Users only on a need-to-know basis and, to the extent a User is not an employee of Client, provided that such User(s) have signed confidentiality agreements with Client containing provisions no less stringent than required in this section. Confidentiality obligations shall not apply to any information which (i) enters the public domain through no fault of Receiving Party; (ii) which was known to Receiving Party prior to receipt from Disclosing Party; (iii) which is disclosed to Receiving Party by a third party which in making such information available to Receiving Party is not in violation of any confidentiality obligation to the Disclosing Party; or (iv) which is independently developed by Receiving Party. In the event that Receiving Party is served with a subpoena, request for information or documents or similar legal process (“Request”) Receiving Party will provide the Disclosing Party with prompt notice of the Request so that Disclosing Party may seek a Protective Order or otherwise seek to limit or protect such Confidential Information and/or documents from disclosure. If and to the extent any legislation applying to the processing of personal data applies to the Client Data or the Services, it is agreed and understood that at all times in undertaking any and all aspects of the Services, Xxxxx Ontrack is acting as a data processor appointed by Client in its capacity as data controller. Client acknowledges and agrees that Client Data may be transferred, accessed, stored and processed in the United States and/or other countries in order to carry out the Services and by using the Services consents to such transfer, processing and use of the Client Data by Xxxxx Ontrack. Xxxxx Ontrack shall maintain appropriate administrative, physical and technical safeguards for the protection of the security, confidentiality and integrity of the Client Data and shall not: (i) access, process, or use Confidential Information for the Client Data except to provide or improve the Services or otherwise at the direction of Client, including to perform any purpose other than the performance of the Clinical Trial, aggregate and de- identified (as support to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposesaddress or prevent technical problems; or (ii) disclose Confidential Information to any third party, Client Data except as permitted compelled by this Section and Section 9 (Publication Rights), as required by Applicable Law law or by a Regulatory Authority, regulation or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Confidential Information to only those Study Personnel and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive Confidential Information of the confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the informed consent processwith Client’s consent.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests under this Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement.
(i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwise.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: Service Agreement
Confidentiality and Data Protection. 7.1 Each All information, in whatever form, provided by one party to the other party which is indicated to be confidential or proprietary or which by its nature is deemed to be confidential or proprietary (“Confidential Information”), shall be considered Confidential Information. Unless with prior written consent of Investigator and Institution shall not: the party disclosing Confidential Information, the receiving party shall:
(i) only use Confidential Information such information for any the purpose other than for which it was provided and to meet its obligations under the performance of the Clinical Trial, aggregate and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; or agreement;
(ii) store it with at least the same degree of care it uses to store its own Confidential Information, but in no event less than a reasonable degree of care; and
(iii) not disclose Confidential Information it to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization . A receiving Party shall not be unreasonably withheldrequired to treat as confidential any information that is already in its possession prior to any disclosure by the disclosing party, which becomes publicly available other than as a result of any breach of this article by the receiving party, which is independently developed by it, or which is lawfully obtained from any third party without restriction on disclosure. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Nothing in this article shall prevent a party from disclosing Confidential Information where ordered to only those Study Personnel do so by a court or a statutory or regulatory body with power to order such disclosure. However, in such case, the party ordered to disclose Confidential Information shall inform and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive consult with the disclosing party in advance. Notwithstanding the provisions of this article, the receiving party may communicate the Confidential Information of the confidential nature of such information; disclosing party to its employees, consultants and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the suppliers who are directly involved with and/or must be informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreementimplementation of the agreement. Upon first request or upon termination of the agreement for any reason whatsoever, and thereafter make no use of each party shall return to the other party all Confidential Information whatsoeverand any materials (and all copies thereof) on any media belonging to the other party or received from any third party by the other party which is in such party’s possession or under its control and shall confirm in writing to the other party that it has complied in all respects with this article 14. However, other than to protect its rights and interests under this Agreement. Any Confidential Information retained in computer backups IntellectEU shall be maintained in accordance with this Agreement.
(i) Where applicableentitled to retain a copy of the project documentation after expiry or termination of the agreement for reasons related to archiving, Sponsor [insert if applicable: quality control or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] its legal and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly regulatory obligations. If for the purposes of provision of Services hereunder client transfers to IntellectEU and any duly engaged contractors any personal data of any individuals, it is sole responsibility of client to receive approval, under provisions of US legislation and General Data Protection Regulation approved by the Clinical Trial EU Parliament on 14 April 2016, enforced on 25 May 2018 (“GDPR”) and applicable laws and regulations, for transfer of personal data and processing of personal data by IntellectEU and its contractors in EU and in Ukraine. Client guarantees and warrants IntellectEU that all personal data transmitted under this agreement and any SOWs hereto is duly collected and processed under provisions of US law and GDPR and other applicable laws and regulations. IntellectEU shall process any personal data in compliance with the REB-approved informed consent document effective version of IntellectEU Personal Data Protection Policy and Applicable Laweffective legislation.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwise.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: General Terms and Conditions
Confidentiality and Data Protection. 7.1 Each You undertake to treat as strictly private and confidential and to not disclose to third parties any information, data, news or document in any medium relating to the Service which You obtain or receive as a result of Investigator and Institution shall not: entering into or performing these T&C (i) use the “Confidential Information”). The undertaking set out in the paragraph above will not be deemed to be breached if information, news, data and/or documents are already in the public domain when disclosed or the disclosure of such information is required by law or an authority orders the total or partial disclosure of the Confidential Information. For the purposes of this section, Confidential Information for also the TDI&P system, any purpose document, business offer, order or presentation given by TDI&P to You, related to TDI&P business partners’ technology, clients, business plan, promotional and marketing activities, finances and other than the performance business affairs. The confidentiality obligations established herein shall survive termination of these T&C and shall continue until any of the Clinical Trial, aggregate and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; or (ii) disclose Confidential Information to any third party, except as permitted by exception included in this Section and Section 9 (Publication Rights), as section applies. If You are required by Applicable Law statute, applicable law or regulation or by a Regulatory Authoritylegal or regulatory authority, process or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Confidential Information to only those Study Personnel and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive Confidential Information of the confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator proceeding to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient You shall provide [choose Sponsor TDI&P with a reasonably adequate notice (if permitted by law, regulatory or CRO to match contracting party] with notice as promptly as possible the relevant authority) of such requirement so that Sponsor We may timely seek a protective order or other appropriate remedy or waive compliance with the terms of this section. You also agree to cooperate with TDI&P in its efforts to so obtain such a protective order or other remedy, unless prohibited by Applicable Law. If In the event that such protective order or other remedy is not obtained, the notice recipient You shall permit hereunder to furnish only that portion of the Confidential Information which that it is advised by opinion of counsel it is legally required to be disclosed, disclose and shall request exercise reasonable efforts to obtain assurance that confidential treatment for the will be accorded such Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO . With regard to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests under this Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement.
(i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information is required the document uploaded to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with analyzed, TDI&P will store the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except file temporally to the extent strictly necessary for the REB-approved Protocol provision of the Service. TDI&P will apply the technical and informed consent permits or requires otherwiseorganizational measures reasonably needed to keep the temporary file confidential and secure. TDI&P will delete the file as soon as the Service has been performed. The service will deliver to You the metadata of the document which may include personal data. TDI&P will not process the data in any way except as needed as to temporally store the file and visualize the metadata. Our Privacy Policy xxxxx://xxx.xxxxxxxxxxx.xxx/general-terms-use-privacy-policy/privacy- policy/index.html will apply to the extent TDI&P is processing Personal Data to provide the Service.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: Terms and Conditions
Confidentiality and Data Protection. 7.1 Each You shall maintain all non-public information regarding the Fund’s portfolio, including the list of Investigator and Institution portfolio securities held by the Fund, which you receive or have access to in the course of performing your duties hereunder as strictly confidential. You shall not: (i) use Confidential Information for any purpose other than the performance of the Clinical Trial, aggregate and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; not disclose or (ii) disclose Confidential Information disseminate such non-public information to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized party unless such disclosure is approved in writing by [choose Sponsor the Fund or CRO to match contracting party], which authorization the Adviser or is otherwise required by law. You shall not be unreasonably withheld. To protect Confidential Informationuse your knowledge of non-public information regarding the Fund’s portfolio as a basis to place or recommend any securities transactions for your own or your affiliates’ (or your respective directors, Investigator officers and Institution shall: (iemployees) limit dissemination of Confidential Information benefit to only those Study Personnel and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive Confidential Information the detriment of the Fund. If you are requested or required to disclose any confidential information concerning the Fund by any regulatory authority or pursuant to an order of a court or a facially valid administrative, legislative or other subpoena, then you shall, where not prohibited from doing so under applicable laws or regulations, immediately notify the Adviser of the request to allow the Adviser the opportunity to legally contest or limit the scope and terms of any such disclosure required by law. More generally neither party shall disclose to any person (except with the written consent of the other party or where required to do so by a relevant regulatory authority or pursuant to an order of a court or a facially valid administrative, legislative or other subpoena) any information of a confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right other party of Institution and Investigator to disclose Clinical Trial Data as required which it becomes possessed during the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry continuance of this Agreement or upon and each party shall use its reasonable endeavors to prevent any earlier written request by [choose Sponsor or CRO such disclosure. Notwithstanding the foregoing, the parties may disclose in confidence confidential information of the other party (including without limitation to match contracting party] at any time, Institution their affiliates and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than the Board of Trustees of the Fund) as may be permitted by Section 9 (Publication Rights) required in order to perform the services or as required by Applicable Law, except that Institution to enforce their obligations and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance rights under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests under this the Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement.
(i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to The parties each undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement their obligations in relation to personal data under applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwisedata protection law.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Confidentiality and Data Protection. 7.1 Each All information, in whatever form, provided by one party to the other party which is indicated to be confidential or proprietary or which by its nature is deemed to be confidential or proprietary (“Confidential Information”), shall be considered Confidential Information. Unless with prior written consent of Investigator and Institution shall not: the party disclosing Confidential Information, the receiving party shall:
(i) only use Confidential Information such information for any the purpose other than the performance of the Clinical Trial, aggregate for which it was provided and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; or meet its obligations hereunder;
(ii) store it with at least the same degree of care it uses to store its own confidential Information, but in no event less than a reasonable degree of care; and
(iii) not disclose Confidential Information it to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization . A receiving Party shall not be unreasonably withheldrequired to treat as confidential any information that is already in its possession prior to any disclosure by the disclosing party, which becomes publicly available other than as a result of any breach of this article by the receiving party, or which is independently developed by it, or which is lawfully obtained from any third party without restriction on disclosure. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Nothing in this article shall prevent a party from disclosing Confidential Information where ordered to only those Study Personnel do so by a court or a statutory or regulatory body with power to order such disclosure. However, in such case, the party ordered to disclose Confidential Information shall inform and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive consult with the disclosing party in advance as soon as practically possible. Notwithstanding the provisions of this article, the receiving party may communicate the Confidential Information of the confidential nature of such information; disclosing party to its employees, consultants and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the suppliers who are directly involved with and/or must be informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreementthe provision of the services hereunder. Upon first request or upon the end of the Term for any reason whatsoever, and thereafter make no use of each party shall return to the other party all Confidential Information whatsoeverand any materials (and all copies thereof) on any media belonging to the other party or received from any third party by the other party which is in such party’s possession or under its control and shall confirm in writing to the other party that it has complied in all respects with this article 14. However, other than to protect its rights and interests under this Agreement. Any Confidential Information retained in computer backups IntellectEU shall be maintained in accordance with this Agreement.
(i) Where applicableentitled to retain a copy of the project documentation after the end of the Term for reasons related to archiving, Sponsor [insert if applicable: quality control or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] its legal and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly regulatory obligations. If for the purposes of provision of services hereunder client transfers to IntellectEU and any duly engaged contractors any personal data of any individuals, it is sole responsibility of customer to receive approval, under provisions of US legislation and General Data Protection Regulation approved by the Clinical Trial EU Parliament on 14 April 2016, enforced on 25 May 2018 (“GDPR”) and applicable laws and regulations, for transfer of such personal data and processing of personal data by IntellectEU and its contractors in EU and outside EU (in Ukraine). Customer guarantees and warrants IntellectEU that all personal data transmitted hereunder and under any SOW is duly collected and processed under provisions of US law and GDPR and other applicable laws and regulations. IntellectEU shall process any personal data in compliance with effective version of IntellectEU Personal Data Protection Policy, effective GDPR legislation and any applicable local legislation if the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed demands are higher than prescribed by Sponsor or any agent, contractor, third-party service provider or employee of SponsorGDPR. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information thatPublicity: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for For the purposes of public announcements and public presentations of non-confidential information which shall include name and logo of IEU’s customer and end client, name of project and brief description of the Clinical Trial, prior to project the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and Parties will not need any consent in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required unless some details are separately restricted by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored Client in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection lawswriting to IEU. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor Such duly restricted details shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwisedeemed confidential.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: General Terms and Conditions
Confidentiality and Data Protection. 7.1 11.1 Each of Investigator and Institution party shall not: (i) use keep all Confidential Information for any purpose of the other than party strictly confidential; and (ii) use such Confidential Information solely in connection with the performance of the Clinical TrialAgreement and not otherwise or for the benefit of any third party.
11.2 The provisions of clause 11.1 will not apply to any Confidential Information required to be disclosed pursuant to law, aggregate any governmental or regulatory authority or by a court or tribunal of competent jurisdiction but then only to the extent of such required disclosure and de- identified provided (as to Sponsor the extent it is legally permitted to do so) the relevant party agrees the nature and Clinical Trial) metric reporting extent of any disclosure in advance with the other party.
11.3 Notwithstanding clause 11.1, a party shall be permitted to third parties, and for internal training and quality assurance purposes; or (ii) disclose Confidential Information to any third partyits personnel or professional advisors and, except as permitted by this Section and Section 9 (Publication Rights)in the case of ArrowXL, as required by Applicable Law or by to ArrowXL Group, on a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Confidential Information to only those Study Personnel and other personnel having a "need to know"; know basis for the performance of its obligations or receipt of benefits under the Agreement provided always that it procures that any recipient complies with confidentiality obligations equivalent to those set out in this clause 11.
11.4 On the termination or expiry of the Agreement each party shall promptly return or (iiwhere directed by the other party) advise otherwise securely dispose of, all Study Personnel and other personnel who receive Confidential Information of the confidential nature other party.
11.5 Neither party will make any announcement or publicity statement relating to the existence of the Agreement or its subject matter without the other party’s prior written consent (except as required by law or by any legal or regulatory authority).
11.6 In the event that ArrowXL transfers any ‘personal data’ (as defined in the General Data Protection Regulation - ‘GDPR’) to the Supplier, the Supplier shall comply with all applicable data protection and privacy legislation for the time being in force including the GDPR regarding the processing of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit personal data regardless of whether the right of Institution and Investigator to disclose Clinical Trial Data Supplier is classified as required during a processor or a controller within the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion meaning of the Confidential Information which is legally required to be disclosed, GDPR. Where applicable and upon request the Supplier shall request confidential treatment for the Confidential Information.
7.3 Upon expiry of this complete and execute ArrowXL’s standard Data Processing Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution modified from time to time and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes doing so this shall be incorporated into these Terms and ongoing compliance under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests under this the Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement.
(i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required Failure by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials Supplier to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor provision shall be liable for any a material breach of the foregoing by any of its representatives. Sponsor acknowledges that Agreement and these Terms giving rise to an immediate right for ArrowXL to terminate the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwisesame.
7.6 This section 7 shall survive expiry 11.7 Each party will indemnify the other (including, in the case of ArrowXL, each member of ArrowXL Group), against all Losses incurred as a result of or termination in connection with any breach by that party or anyone acting on behalf of that party of this Agreement clause 11.
11.8 The obligations in this clause shall continue for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitelya period of 5 years following termination.
Appears in 1 contract
Samples: Terms of Purchase
Confidentiality and Data Protection. 7.1 Each party agrees that they may disclose to the other party (“Receiving Party”), during the course of Investigator and Institution shall not: this Agreement, business or technical information of a confidential nature (i“Confidential Information”) use to the disclosing party (“Disclosing Party”). Confidential Information includes, without limitation, employee data, financial information not otherwise disclosed to the public, patent and patent applications, trade secrets, copyrighted information and other intellectual property, business and marketing plans, the identity of customers and suppliers, future products, product developments and other proprietary information. Any written document or other tangible material will be appropriately marked by the Disclosing Party to indicate whether it contains Confidential Information; however, information in the form of data transmitted electronically which falls within the list of examples above need not be appropriately marked to be Confidential Information and shall be protected pursuant to this provision. Except for data transmitted electronically as provided above, at the time of disclosure, the Disclosing Party will inform the Receiving Party about the confidential nature of any purpose Confidential Information that is not in a written document or other than tangible material form. Each party agrees not to use or disclose the performance Confidential Information of the Clinical Trialother party for its own benefit, aggregate and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and or for internal training and quality assurance purposes; or (ii) disclose Confidential Information to the benefit of any third party, except as permitted by may be required in their performance under this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization Agreement. The Confidential Information shall not be unreasonably withheld. To protect Confidential Informationtreated as confidential, Investigator and Institution shalleven if it is designated as such by the Disclosing Party if: (i) limit dissemination it is or becomes available to the public without confidentiality restrictions through no unauthorized act of Confidential Information to only those Study Personnel and other personnel having a "need to know"the Receiving Party; (ii) advise all Study Personnel and other personnel is received from a third party who receive is not under an obligation of confidence to the Disclosing Party; or iii) is independently developed by employees or contractors of the Receiving Party who did not use the Confidential Information of the confidential nature other party in the development. A Party shall not be in breach of this provision if it is required to disclose Confidential Information pursuant to a requirement of a governmental agency or law, provided such Party gives prompt notice to the Disclosing Party of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator obligation to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any such Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy This Agreement is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which of the parties. All of a party’s Confidential Information is legally required to be disclosed, the exclusive property of such party and shall request confidential treatment for the furnishing of the such party’s Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party]Information to, or destroyaccess to such items by, at [choose Sponsor the other party and/or its subcontractors will not grant any express or CRO implied license to match contracting party]'s option and expense, all Confidential Information or interest in such other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of party and/or its subcontractors relating to such Confidential Information in except as required to perform the services pursuant to this Agreement. Upon request by a secure location for archival purposes the disclosing party at any time and ongoing compliance from time to time and without regard to the default status of the Parties under this Agreement, and thereafter make no use of the receiving party and/or its subcontractors shall promptly deliver to the disclosing party its Confidential Information whatsoeverin such format as specified by the disclosing party. All right, other than title and interest in and to protect property, data (including personal data), information, equipment, supplies and materials provided by Customer or its rights affiliates (the “Customer Materials”) shall remain at all times vested in Customer or its affiliates, and interests under this Agreement. Any Confidential Information retained in computer backups nothing contained herein shall be maintained deemed in accordance with this Agreement.
(i) Where applicableany way to transfer any ownership or other interest therein to Caregility. Customer grants to Caregility a non-exclusive, Sponsor [insert if applicable: or CRO] may have access limited, fully paid license during the Term to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with use the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and Customer data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the sole purpose of the Clinical Trial performing Services for which the biological materials were collected and Customer in accordance with the informed consentsterms and conditions of this Agreement and any SOW. All right, REB-approved Protocoltitle and interest in and to property, data, information, equipment, supplies and materials provided by Caregility in the performance of the Services shall remain at all times vested in Caregility, and Applicable Lawnothing contained herein shall be deemed in any way to transfer any ownership or other interest therein to Customer. Caregility grants Customer a non-exclusive, including privacy limited, fully paid license during the Term to use the Caregility furnished data, software or IP for the sole purpose of utilizing the Services in accordance with the terms and conditions of this Agreement and any SOW While in possession of Customer data, Caregility shall use said data protection laws. Sponsor only for the intended purpose and to the extent necessary for the proper performance of the Contract and shall not make process the data for any attempt other purpose. Data will be treated as Customer confidential in accordance with Caregility’s Customer Data Privacy Policy (xxxx://xxx.Xxxxxxxxxx.xxx/privacy-policy/) and secured in accordance with Caregility’s ISO27001 procedures. Caregility is Privacy Shield Certified. By acceptance of these terms and conditions customer agrees that Caregility can store EU customer data in the US. Our Privacy Shield certification status grants Caregility the legal basis to re-identify Clinical Trial Participants with store the biological materials or contact any such Clinical Trial ParticipantsEU customer's data in the US. Sponsor shall require any Sponsor-designated representative receiving biological materials to Evidence of certification can be found at xxxxx://xxx.xxxxxxxxxxxxx.xxx/participant?id=a2zt0000000PDMCAA4&status=Active. Caregility and Customer will comply with all Applicable Law Data Protection legislation as applicable, including but not limited to the EU General Data Protection Regulation (GDPR). With Customer permission, Caregility may use customer data to conduct user satisfaction surveys. Each party agrees to obtain all necessary consents under applicable data protection and privacy laws and will not pass personal data to the other party or to third parties without prior notification to the data subject. Each party agrees to obtain all necessary consents under applicable data protection and privacy laws and will not pass personal data to the other party or to third parties without prior notification to the data subject. By acceptance of these terms and conditions, the Customer (Data Controller) acknowledges and authorizes Caregility subcontractors to be sub-processors of this Agreement applicable to such biological materials, Customer Data only for the intended purpose and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent necessary for the REB-approved Protocol proper performance of the SOW and informed consent permits or requires otherwiseshall not process the data for any other purpose.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: Procurement Agreement
Confidentiality and Data Protection. 7.1 Each 19.1. The Subcontractor acknowledges that it may receive or become aware of Investigator and Institution shall not: (i) use the Customer’s Confidential Information or other Confidential Information from Securitas and/or the Customer and agrees that it shall keep and cause the Security Personnel to keep confidential the Customer Confidential Information and other Confidential Information, and the Subcontractor agrees not to disclose or use and to cause Subcontractor’s Personnel not to disclose or use said information unless such disclosure is necessary for the purpose of performing the Services under this Agreement or required by law. If the Subcontractor has questions regarding what comprises Confidential Information, it shall consult Securitas.
19.2. The Subcontractor shall employ security procedures to prevent disclosure of Securitas’s or Customer’s Confidential Information or Confidential Information (including Personal Information) to unauthorized third parties, if the Subcontractor and/or its Personnel hold any purpose Customer Confidential Information or other than Confidential Information. The Subcontractor and its Personnel or agents are required to sign an undertaking provided by the Customer to safeguard official information (if required by the Customer).
19.3. If the Subcontractor collects or accesses any Personal Information as part of the performance of the Clinical TrialServices, aggregate the Subcontractor agrees to comply with all applicable requirements provided by the Customer.
19.4. The Subcontractor shall procure that all its employees, servants and de- identified agents and those of its subcontractors (as if approved by the Securitas) and agents to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; or (ii) disclose whom Confidential Information is to be made available observe the obligations contained in this Article 19 and shall, at the request of the Securitas, procure that each of its employees servants and agents and those of its subcontractors and agents sign an undertaking to safeguard official information, if required by Securitas and/or the Customer.
19.5. The Subcontractor will not issue any press releases or other publicity related to the Subcontractor’s relationship with Securitas and/or the Customer, or any other information or material pertaining to any third partypart of the obligations to be performed under this Agreement in any media, except as permitted by this Section without prior written approval of Securitas and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization the Customer.
19.6. The Subcontractor shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination liable for disclosure of Confidential Information in the event and to only those Study Personnel and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive the extent any Confidential Information of the confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreement, and thereafter make no use of Confidential Information whatsoever, other than to protect its rights and interests under this Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement.
(i) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with disclosed by the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect Subcontractor pursuant to any biological materials applicable law, regulations or directives of any relevant government, statutory or regulatory body (including stock exchange) or pursuant to be transferred to Sponsor any legal process issued by any court or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose tribunal of the Clinical Trial for which the biological materials were collected and competent jurisdiction in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach provisions of the foregoing by any of its representatives. Sponsor acknowledges that Agreement, provided the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical TrialSubcontractor shall, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent practicably possible and permissible by law or regulations, give Securitas prompt and prior notice of any such requirement and shall cooperate with Securitas to limit the REB-approved Protocol and informed consent permits or requires otherwisescope of such disclosure to the maximum extent legally possible.
7.6 19.7. This section 7 Article shall survive expiry or termination of this Agreement for seven years, excepting apply during the provisions related to Personal Information Term and biological materials, which shall survive indefinitelyfive (5) years thereafter.
Appears in 1 contract
Samples: Terms and Conditions Agreement
Confidentiality and Data Protection. 7.1 Each All information, in whatever form, provided by one party to the other party which is indicated to be confidential or proprietary or which by its nature is deemed to be confidential or proprietary (“Confidential Information”), shall be considered Confidential Information. Unless with prior written consent of Investigator and Institution shall not: the party disclosing Confidential Information, the receiving party shall:
(i) only use Confidential Information such information for any the purpose other than the performance of the Clinical Trial, aggregate for which it was provided and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; or meet its obligations hereunder;
(ii) store it with at least the same degree of care it uses to store its own confidential Information, but in no event less than a reasonable degree of care; and
(iii) not disclose Confidential Information it to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization . A receiving Party shall not be unreasonably withheldrequired to treat as confidential any information that is already in its possession prior to any disclosure by the disclosing party, which becomes publicly available other than as a result of any breach of this article by the receiving party, or which is independently developed by it, or which is lawfully obtained from any third party without restriction on disclosure. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Nothing in this article shall prevent a party from disclosing Confidential Information where ordered to only those Study Personnel do so by a court or a statutory or regulatory body with power to order such disclosure. However, in such case, the party ordered to disclose Confidential Information shall inform and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive consult with the disclosing party in advance as soon as practically possible. Notwithstanding the provisions of this article, the receiving party may communicate the Confidential Information of the confidential nature of such information; disclosing party to its employees, consultants and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the suppliers who are directly involved with and/or must be informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under this Agreementthe provision of the services hereunder. Upon first request or upon the end of the Term for any reason whatsoever, and thereafter make no use of each party shall return to the other party all Confidential Information whatsoeverand any materials (and all copies thereof) on any media belonging to the other party or received from any third party by the other party which is in such party’s possession or under its control and shall confirm in writing to the other party that it has complied in all respects with this article 14. However, other than to protect its rights and interests under this Agreement. Any Confidential Information retained in computer backups IntellectEU shall be maintained in accordance with this Agreement.
(i) Where applicableentitled to retain a copy of the project documentation after the end of the Term for reasons related to archiving, Sponsor [insert if applicable: quality control or CRO] may have access to Clinical Trial Participant Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] its legal and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly regulatory obligations. If for the purposes of provision of services hereunder client transfers to IntellectEU and any duly engaged contractors any personal data of any individuals, it is sole responsibility of customer to receive approval, under provisions of General Data Protection Regulation approved by the Clinical Trial EU Parliament on 14 April 2016, enforced on 25 May 2018 (“GDPR”) and applicable laws and regulations, for transfer of such personal data and processing of personal data by IntellectEU and its contractors in EU and outside EU (in USA and Ukraine). Customer guarantees and warrants IntellectEU that all personal data transmitted hereunder and under and any SOW is duly collected and processed under provisions of GDPR and applicable laws and regulations. IntellectEU shall process any personal data in compliance with effective version of IntellectEU Personal Data Protection Policy, effective GDPR legislation and any applicable local legislation if the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed demands are higher than prescribed by Sponsor or any agent, contractor, third-party service provider or employee of SponsorGDPR. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information thatPublicity: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for For the purposes of public announcements and public presentations of non-confidential information which shall include name and logo of IEU’s customer and end client, name of project and brief description of the Clinical Trial, prior to project the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and Parties will not need any consent in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required unless some details are separately restricted by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored Client in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection lawswriting to IEU. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor Such duly restricted details shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwisedeemed confidential.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: General Terms and Conditions
Confidentiality and Data Protection. 7.1 Each (a) Because of Investigator and Institution shall not: this Agreement, the parties may have access to information that is confidential to one another (i) use "Confidential Information"). Confidential Information for any purpose other than shall include the performance of the Clinical TrialXxxxxxxxx Materials, aggregate including all source and de- identified (as to Sponsor and Clinical Trial) metric reporting to third parties, and for internal training and quality assurance purposes; or (ii) disclose Confidential Information to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Confidential Information to only those Study Personnel and other personnel having a "need to know"; (ii) advise all Study Personnel and other personnel who receive Confidential Information of the confidential nature of such information; and (iii) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution or Investigator receives notice from a third party seeking to compel disclosure of any Confidential Informationobject code, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the Confidential Information which is legally required to be disclosed, terms and shall request confidential treatment for the Confidential Information.
7.3 Upon expiry of this Agreement or upon any earlier written request by [choose Sponsor or CRO to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance pricing under this Agreement, and thereafter make no use of all information designated as confidential or which should reasonably be considered to be confidential. A party's Confidential Information whatsoevershall not include any information which (i) becomes part of the public domain through no act or omission of the other party; (ii) is lawfully acquired by the other party from a third party without any breach of confidentiality; or (iii) was available to the receiving party prior to disclosure by the disclosing party without any obligation of confidentiality. The parties agree to maintain the confidentiality of the Confidential Information by preventing any unauthorised copying, use, distribution, installation or transfer of possession of such information. Each party agrees to maintain at least the same procedures regarding Confidential Information that it maintains with respect to its own Confidential Information. Without limiting the generality of the foregoing, Customer shall not permit any personnel or Authorised User to remove any proprietary or other legend or restrictive notice contained or included in any material provided by Xxxxxxxxx and Customer shall not permit Customer’s personnel or Authorised Users to reproduce or copy any such material except as expressly Authorised hereunder.
(b) Both parties acknowledge that any use or disclosure of the other party's Confidential Information in a manner inconsistent with the provisions of this Agreement may cause irreparable damage for which remedies other than injunctive relief may be inadequate, and both parties agree that the other party shall be entitled to protect its rights seek from a court of competent jurisdiction injunctive or other equitable relief to restrain such use or disclosure in addition to other appropriate remedies.
(c) Both parties shall comply with any separately agreed Data Processing Agreement. The parties affirm that either party’s liability arising out of or related to a Data Processing Agreement, whether in contract, tort or under any other theory of liability, is subject to clause 11 (Limitation of Remedies) of this Agreement, and interests any references in such clause to the liability of a party means the aggregate liability of that party under this Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement and any Data Processing Agreement.
(id) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant Personal Information. This information Customer is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and responsible for conducting any data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer impact or disclosure of Clinical Trial Participant Personal Information strictly for the purposes of the Clinical Trial and similar risk assessment in compliance with the REB-approved informed consent document and Applicable Law.
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access relation to the Personal Informationprovision of Customer Data to Xxxxxxxxx.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consents, REB-approved Protocol, and Applicable Law, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwise.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
Appears in 1 contract
Samples: General Terms and Conditions
Confidentiality and Data Protection. 7.1 8.1. Each of Investigator Party:
i. must keep secret and Institution shall not: (i) use confidential all Confidential Information for any purpose disclosed to it; and
ii. must not disclose the Confidential Information (other than to its Affiliates, employees, consultants, subcontractors, agents, professional advisers or insurers and their employees, consultants, subcontractors, agents, professional advisers or insurers and any of its or its Affiliates' financiers or potential financiers (the performance of the Clinical Trial, aggregate and de- identified (as to Sponsor and Clinical Trial"Authorized Recipients") metric reporting to third parties, and for internal training and quality assurance purposes; or (ii) disclose Confidential Information to any third party, except as permitted by this Section and Section 9 (Publication Rights), as required by Applicable Law or by a Regulatory Authority, or as authorized in writing by [choose Sponsor or CRO to match contracting party], which authorization shall not be unreasonably withheld. To protect Confidential Information, Investigator and Institution shall: (i) limit dissemination of Confidential Information to only those Study Personnel and other personnel having on a "need to know"; (ii" basis) advise all Study Personnel and other personnel who receive except with the prior written consent of the Party whose Confidential Information is being disclosed. Disclosure to any Authorized Recipient will be subject to the Authorized Recipient being bound by obligations equivalent to those set out in this clause 8. The person disclosing Confidential Information to an Authorized Recipient must ensure that such Authorized Recipient complies with such obligations.
8.2. The obligations of confidentiality in this clause will not apply to any information that either Party can show:
(a) is in, or has become part of, the public domain other than as a result of a breach of the obligations of confidentiality under this Agreement; or
(b) was in its own written records prior to the disclosure to it of the confidential nature of such informationInformation; and or
(iiic) protect Confidential Information from disclosure. Nothing herein shall limit the right of Institution and Investigator was independently disclosed to disclose Clinical Trial Data as required during the informed consent process.
7.2 If Institution or Investigator receives notice from it by a third party seeking entitled to compel disclosure disclose the same.
8.3. The obligations of confidentiality in this clause will not prevent either Partner or TourScanner from disclosing such Confidential Information where it is required to do so under any applicable law or the rules of any recognized stock exchange or by order of a court or governmental body of authority of competent jurisdiction or a mandatory requirement of any regulatory authority.
8.4. Each Party must establish and maintain such security measures and procedures as are reasonably practicable to provide for the safe custody of any Confidential Information in its possession and to prevent unauthorized access to or use of such Confidential Information, the notice recipient shall provide [choose Sponsor or CRO to match contracting party] with notice as promptly as possible so that Sponsor . Neither Party may seek a protective order or other appropriate remedy, unless prohibited by Applicable Law. If such protective order or other remedy is not obtained, the notice recipient shall furnish only that portion of the use Confidential Information which is legally or reproduce such Confidential Information in whole or in part in any form except as may be required to be disclosed, and shall request confidential treatment for the Confidential Informationby this Agreement.
7.3 Upon expiry 8.5. Personal Data shall be defined as per the EU General Data Protection Regulation ("GDPR") or any analogous law in any country which has jurisdiction in relation to the subject matter of this Agreement or upon any earlier written request by [choose Sponsor or CRO data to match contracting party] at any time, Institution and Investigator shall return to [choose Sponsor or CRO to match contracting party], or destroy, at [choose Sponsor or CRO to match contracting party]'s option and expense, all Confidential Information other than as may be permitted by Section 9 processed under this Agreement (Publication Rights) or as required by Applicable Law, except that Institution and Investigator may retain one copy of such Confidential Information in a secure location for archival purposes and ongoing compliance under "Data Protection Legislation"). Under this Agreement, Personal Data may be transferred by Partner to TourScanner, or Partner may assist in a transfer of Personal Data by a Partner Customer to TourScanner, in particular where a booking is made through the API or if Partner is a travel-agency making a booking for and thereafter make no use on behalf of a Partner Customer. In case of a booking through a link, anonymous or pseudonymous information such as cookie IDs or TourScanner Partner IDs, may be provided to TourScanner. The Parties agree that, with regard to such Personal Data (including pseudonymous data) and such transfer, both Parties are independent data controllers and are not data processors or joint controllers within the meaning of the GDPR. In the event that either Party processes any Personal Data contained in the Confidential Information whatsoeverof, or that is otherwise supplied by, the other than Party or its Affiliates, such Party hereby agrees to protect its rights process such Personal Data at all times in compliance with Data Protection Legislation, and interests under this Agreement. Any Confidential Information retained in computer backups shall be maintained in accordance with this Agreement.to adhere to all applicable requirements for the processing of Personal Data, including, but not limited to:
(ia) Where applicable, Sponsor [insert if applicable: or CRO] may have access to Clinical Trial Participant process Personal Information. This information is required to be protected under Canadian and provincial laws and Sponsor [insert if applicable: and CRO] shall treat all Clinical Trial Participant Personal Information it may come in contact with as confidential.
(ii) Sponsor [insert if applicable: and CRO] shall comply with the applicable requirements of both [insert applicable province of Institution] and Canadian privacy and data protection laws, including the [insert applicable provincial personal health information law] and the Personal Information Protection and Electronic Documents Act (“PIPEDA”), and shall limit the use, transfer or disclosure of Clinical Trial Participant Personal Information strictly Data only for the purposes of providing the Clinical Trial and in compliance with the REB-approved informed consent document and Applicable Law.services under this Agreement;
(iii) Sponsor shall keep confidential and secure any Personal Information, regardless of format, obtained or accessed by Sponsor or any agent, contractor, third-party service provider or employee of Sponsor. Sponsor shall ensure appropriate administrative, technological and physical safeguards are put in place, using current industry best practices, to protect the Personal Information against risks such as unauthorized access, use, disclosure, copying, modification, disposal, loss or theft.
(iv) Sponsor confirms that, for those accessing Personal Information, it has a program of education for its employees, contractors and agents on privacy, confidentiality and security of information. Sponsor shall ensure that its employees, contractors and agents are aware of their privacy and confidentiality obligations, and that employees, contractors and agents who resign or are terminated return all Personal Information to Sponsor, are reminded of their continued responsibility to maintain the information’s confidentiality, and no longer have access to the Personal Information.
(v) Sponsor represents and warrants that if it engages any third-party service providers who will have access to Personal Information that: (a) they are subject to obligations of confidentiality and privacy substantially similar to those contained herein, and (b) they will not share Clinical Trial Participant process Personal Information with Sponsor or any other third party, except as explicitly provided for in the REB-approved informed consent document.
(vi) Sponsor agrees that Institution retains custody and control of Clinical Trial Participant Personal Information.
(vii) [choose Sponsor or CRO to match contracting party] shall, working with Institution and Investigator, ensure that any Clinical Trial Participant Personal Information is removed from any equipment or devices that were brought into Institution for the purposes of the Clinical Trial, prior to the equipment leaving Institution.
(viii) Sponsor shall notify Institution within one day and in writing if it becomes aware of a privacy, confidentiality or security breach relating to Personal Information. In the event of a breach, Sponsor shall consult with Institution and Investigator to identify the root cause of the breach and the affected information, to undertake and implement possible mitigation measures, and to determine appropriate measures to prevent the recurrence of such a breach.
(ix) Upon expiry or termination of this Agreement, or upon request, Sponsor shall cease any and all use of the Clinical Trial Participant Personal Information and shall at no cost return it to Institution, including any copies, or shall destroy it in a manner designated by Institution with proof of destruction.
7.5 With respect to any biological materials to be transferred to Sponsor or any Sponsor-designated representative for testing or analyses, as required by the Protocol and permitted by Clinical Trial Participants’ informed consents, such biological materials shall: (i) be transferred via a secure mode; (ii) be stored in a secure location with limited access; and (iii) Data only be used for the purpose of the Clinical Trial for which the biological materials were collected and in accordance with the informed consentsData Protection Legislation; and
(c) having appropriate operational and technical measures in place to safeguard the Personal Data against any unauthorized access, REB-approved Protocolloss, and Applicable Lawdestruction, including privacy and data protection laws. Sponsor shall not make any attempt to re-identify Clinical Trial Participants with the biological materials theft, use or contact any such Clinical Trial Participants. Sponsor shall require any Sponsor-designated representative receiving biological materials to comply with all Applicable Law and the terms of this Agreement applicable to such biological materials, and Sponsor shall be liable for any breach of the foregoing by any of its representatives. Sponsor acknowledges that the biological materials transferred under this Agreement are experimental in nature and may have infectious and/or hazardous properties and that Sponsor and any Sponsor-designated representatives have the necessary facilities and expertise to safely handle such biological materials. Promptly following conclusion of the Clinical Trial, Sponsor shall and shall cause its designated representatives to destroy such biological materials in a secure fashion and in compliance with Applicable Law except to the extent the REB-approved Protocol and informed consent permits or requires otherwisedisclosure.
7.6 This section 7 shall survive expiry or termination of this Agreement for seven years, excepting the provisions related to Personal Information and biological materials, which shall survive indefinitely.
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Samples: Distribution Agreement
