Common use of Human Biological Samples Clause in Contracts

Human Biological Samples. 25.1 Where the Sponsor or third parties for which the Sponsor is responsible supply HBS to Covance in connection with the Services, the Sponsor represents and warrants that: (a) all HBS supplied in connection with the Services under this Agreement and any relevant Work Order are or have been procured and supplied to Covance ethically in full compliance with any and all applicable national laws, regulations, or codes of practice (including any submissions, approvals and registrations to any applicable Regulatory Authority) relating to the Use of HBS providing protection for human subjects in the country of origin; (b) the HBS Donor has given Informed Consent; (c) all HBS shall be supplied to Covance without any information or data that could allow Covance to personally identify the HBS Donor under applicable Data Protection Laws and other applicable Regulatory Requirements; and (d) all HBS supplied to Covance: (i) may be Used for the Services; (ii) may be used to provide data in support of commercial product development; and (iii) were procured without inappropriate financial benefit to the HBS Donor; (e) provided that, if either Party learns that any of the above representations are not accurate, it shall inform the other Party and the Parties shall take reasonable steps to cure as applicable to its responsibilities, which may include obtaining Informed Consent or removal of applicable personal identifiers. 25.2 The Sponsor shall: (a) upon request, provide a copy of the relevant Informed Consent template; (b) upon request, provide a copy of the relevant documents certifying that the HBS provided to Covance has completed the necessary submissions, approvals and registrations required to be made to any applicable Regulatory Authority; and (c) ensure any HBS shall be de-identified or 'coded' according to applicable Regulatory Requirements to protect the identity and confidentiality of the HBS Donor. Full date of birth shall only be collected if medically relevant to the Services (unless legally restricted in the country of operation). 25.3 In the event of a withdrawal of, or a material variation to the Informed Consent (including any material changes that may affect the Services provided by Covance) the Sponsor shall promptly notify all relevant Covance entities of such changes. 25.4 Covance agrees to use the HBS in accordance with all applicable national laws, regulations and codes of practice. 25.5 Upon the Sponsor's request, Covance shall retain, return or dispose of all HBS in accordance with the Informed Consent, the Sponsor's reasonable instructions or any other specific requirements under applicable national law. 25.6 The Sponsor acknowledges that where Covance enters into a material transfer agreement (MTA) with the provider of any HBS, Covance shall act in accordance with the terms of the MTA and the disposition of the relevant HBS shall be as prescribed in the MTA. In the event of a conflict between the terms of the MTA, this Agreement, any Work Order and any instructions provided by the Sponsor, the terms of the MTA shall prevail.

Human Biological Samples. 25.1 Where Covance is performing Services that includes monitoring activities of a Study on behalf of the Sponsor at investigative sites, Covance shall: (a) verify that the HBS Donor has given Informed Consent; (b) confirm that any HBS and associated data are managed in full compliance with any and all applicable national laws, regulations, or codes of practice (including any submissions, approvals and registrations to any applicable Regulatory Authority) relating to the Use of HBS providing protection for human subjects in the country of origin; (c) use its reasonable efforts to ensure that any HBS shall be de-identified or ‘coded’ according to applicable Regulatory Requirements to protect the identity and confidentiality of the HBS Donor; and (d) in the event of a withdrawal of or a material variation to the Informed Consent, promptly notify all relevant parties of such withdrawal or variation. 25.2 In all other circumstances, where the Sponsor or third parties for which the Sponsor is responsible supply HBS to Covance in connection with the Services, the Sponsor represents and warrants that: (a) all HBS supplied in connection with the Services under this Agreement and any relevant Work Order are or have been procured and supplied to Covance ethically in full compliance with any and all applicable national laws, regulations, or codes of practice (including any submissions, approvals and registrations to any applicable Regulatory Authority) relating to the Use of HBS providing protection for human subjects in the country of origin; (b) the HBS Donor has given Informed Consent; (c) all HBS shall be de-identified or ‘coded’ according to applicable Regulatory Requirements to protect the identity and confidentiality of the HBS Donor and shall be supplied to Covance without any information or data that could allow Covance to personally identify the HBS Donor under applicable Data Protection Laws and other applicable Regulatory Requirements; and; (d) all HBS supplied to Covance: Covance (i) may be Used for the Services; (ii) may be used to provide data in support of commercial product developmentdevelopment by Sponsor; and (iii) were procured without inappropriate financial benefit to the HBS Donor;; and (e) provided thatin the event of a withdrawal of, if either Party learns or a material variation to the Informed Consent (including any material changes that any of may affect the above representations are not accurateServices), it shall inform the promptly notify Covance and any other Party and the Parties shall take reasonable steps to cure as applicable to its responsibilities, which may include obtaining Informed Consent relevant parties of such changes or removal of applicable personal identifierswithdrawal. 25.2 25.3 The Sponsor shall: (a) upon request, provide a copy of the relevant Informed Consent template; and (b) upon request, provide a copy of the relevant documents certifying that the HBS provided to Covance has completed the necessary submissions, approvals and registrations required to be made to any applicable Regulatory Authority; and (c) ensure any HBS shall be de-identified or 'coded' according to applicable Regulatory Requirements to protect the identity and confidentiality of the HBS Donor. Full The Sponsor agrees that full date of birth shall only be collected if medically relevant to the Services (unless legally restricted in the country of operation). 25.3 In the event of a withdrawal of, or a material variation to the Informed Consent (including any material changes that may affect the Services provided by Covance) the Sponsor shall promptly notify all relevant Covance entities of such changes. 25.4 Covance agrees to use the HBS in accordance with all applicable national laws, regulations and codes of practice. Covance shall not use the HBS, even on a de-identified or coded basis for any purpose other than in accordance with the signed Informed Consent form. 25.5 Upon the Sponsor's ’s request, Covance shall retain, return or dispose of all HBS in accordance with the Informed Consent, the Sponsor's ’s reasonable instructions or any other specific requirements under applicable national law. 25.6 The Sponsor acknowledges that where Covance enters into a material transfer agreement (MTA) with the provider of any HBS, Covance shall act in accordance with the terms of the MTA and the disposition of the relevant HBS shall be as prescribed in the MTA. In the event of a conflict between the terms of the MTA, this Agreement, any Work Order and any instructions provided by the Sponsor, the terms of the MTA shall prevail.