Human Biological Samples. i) Where Human Biological Samples have or will be collected or obtained by or on behalf of Tempus for or on behalf of GSK, the consent form used will include appropriate statements required by Applicable Law to permit Tempus to perform the Activities with respect to such Human Biological Samples, including but not limited to informing the donor (and in the case of post mortem Human Biological Samples, supplied with consent provided by or on behalf of the original donor) of the following and receiving consent therefor: a. the Human Biological Sample may be used for research purposes which may include DNA and/or Personal Information research or analysis (as applicable) and does not exclude the Activities; b. the Human Biological Sample may be transferred to a third party for testing, a subsequent research use and storage purposes conducted for and on behalf of a commercial organisation and its third-party collaborators; c. that the Human Biological Sample and any accompanying clinical information will be either anonymised or coded before use of the Human Biological Sample; d. that a commercial organisation will have ownership of the Results and may file patents or otherwise protect and commercialise any Results; and e. there will be no financial benefit to the donor whatsoever in respect of commercialisation of the Results or the original human tissue sample; ii) Tempus will use the Human Biological Samples only for the purposes that are consistent with consent referred to under paragraph (i) above. iii) No human embryonic or foetal derived material (including cell lines) will be used in connection with performance of the Activities or the Deliverables without the express prior written approval of GSK. iv) The party that provides Human Biological Samples required for Tempus’s provision of the Activities certifies (and, in respect of Human Biological Samples that are obtained from a third party, its Tempus of those Human Biological Samples) it has all the necessary authorisations, licenses, consents and approvals (for example, ethical approval from an ethics committee, or as may be otherwise prescribed by Applicable Law) to obtain, collect, store, transfer, use (including subsequent use by a commercial organisation), disclose, import, export and dispose of the Human Biological Samples in Tempus’s performance of the Activities. v) each party will comply with and will continue to comply with all Applicable Law and issued codes of practice and guidance relating to the collection, storage, use and disposal of Human Biological Samples for use in the performance of the Activities and vi) The party that provides Human Biological Samples required for Xxxxxx’s performance of the Activities certifies that appropriate consent at the material time has on all occasions been given to the extent by Applicable Law and will be obtained by/from an appropriate Person in respect of Human Biological Samples collected, transferred, stored, used and subsequently disposed of.
Appears in 2 contracts
Samples: Strategic Collaboration Agreement (Tempus AI, Inc.), Strategic Collaboration Agreement (Tempus Labs, Inc.)
Human Biological Samples. 23.1 Tempus (and, in respect of HBS that are obtained from another party, Tempus’s suppliers of those HBS) represents and warrants that: (i) Where Human Biological Samples have it has all the necessary authorisations, licenses, consents and approvals; (ii) it will comply with all Applicable Law relating to collection, storage, transfer, use (including subsequent use by a commercial organisation), disclosure, import, export and disposal of the HBS; and (iii) it will not use human embryonic or foetal derived material (including cell lines) without the express prior written approval of GSK.
23.2 If Tempus is using warranted HBS only, whether provided to GSK or not, for research not including genetic analysis, Tempus represents and warrants that: (i) no human embryonic or foetal derived material (including cell lines) will be used without the express prior written approval of GSK; (ii) appropriate and adequate donor consent and/or ethics committee approval (as required by Applicable Law) has been or will be obtained; and (iii) if the proposed use of HBS may include genetics analysis, Tempus will immediately inform GSK (and in any event, prior to commencing such analysis), which such communication may be documented in the applicable Task Order.
23.3 If Tempus has collected or obtained by or on behalf of Tempus for or and is using, in each case on behalf of GSK, tracked, restricted, or warranted HBS for research including genetic analysis (whether provided to GSK or not), then to the consent form used will include appropriate statements extent required by Applicable Law to permit Law, Tempus to perform will ensure the Activities with respect to such Human Biological Samples, including but not limited to informing consent provided by the donor (and in the case of post mortem Human Biological SamplesHBS, supplied with consent provided by or on behalf of the original donor) of acknowledged the following and receiving consent therefor:
a. following: (i) the Human Biological Sample HBS may be used for research purposes which may include purposes, including DNA and/or Personal Information personal data research or analysis (as applicable) analysis, and does not exclude the Activities;
b. ; (ii) the Human Biological Sample HBS may be transferred to a third party for testing, a subsequent research use and storage purposes conducted for and on behalf of a commercial organisation and its third-party collaborators;
c. that ; (iii) a commercial organisation will have ownership of the Human Biological Sample results of the research performed on the HBS and there will be no benefit whatsoever or any form of compensation for the donor in respect of the use of the HBS by the commercial organisation; (iv) the HBS and any accompanying clinical information will be either anonymised or coded before use of the Human Biological Sample;
d. that a commercial organisation will have ownership of the Results use; and may file patents or otherwise protect and commercialise any Results; and
e. there will be no financial benefit to the donor whatsoever in respect of commercialisation of the Results or the original human tissue sample;
ii(v) Tempus will use the Human Biological Samples HBS only for the purposes that are consistent with consent referred to under paragraph above. In addition with respect to such HBS, Tempus will: (ivi) above.
iii) No human embryonic or foetal derived material (including cell lines) will be used prior to commencing use of the HBS in connection with the performance of the Activities any Task Order or the Deliverables without the express prior written approval GSK-SCS Agreement, and subsequently upon GSK’s request, provide consent templates and examples of GSK.
iv) The party ethics documentation to GSK for review; provided, that provides Human Biological Samples required for Tempus’s provision of the Activities certifies (and, in respect of Human Biological Samples that are obtained from a third party, its Tempus of those Human Biological Samples) it has all the necessary authorisations, licenses, consents covenants and approvals (for example, ethical approval from an ethics committee, or as may be otherwise prescribed by Applicable Law) agrees not to obtain, collect, store, transfer, use (including subsequent use by a commercial organisation), disclose, import, export and dispose of the Human Biological Samples in Tempus’s performance of the Activities.
v) each party will comply with and will continue to comply with all Applicable Law and issued codes of practice and guidance relating to the collection, storage, use and disposal of Human Biological Samples for use any HBS in the performance of the Activities andfor which it cannot provide to GSK appropriate consent forms; (vii) record each HBS used under the Agreement in a suitable HBS level tracking system (the “Tracking Records”); (viii) maintain the Tracking Records at all points of the HBS lifecycle, including reporting on the status of each HBS at any time, up to HBS transfer or destruction; and (ix) store the HBS under conditions in Tempus’s premises that are secure, clean and appropriate to maintain HBS biological integrity.
23.4 If GSK is transferring HBS, whether warranted, tracked, or restricted, to Tempus, GSK represents and warrants to Tempus that all uses of HBS under the Agreement fall within the terms of the informed consent given by the donors of the samples. Tempus will: (i) check all HBS provided by or on behalf of GSK on arrival to assess their physical integrity and notify GSK in writing if any HBS have been compromised in transit, within [***] after making such finding; (ii) within [***] of receipt, record each HBS used under this Agreement in the Tracking Records; (iii) maintain the Tracking Records at all points of the HBS lifecycle, including reporting on the status of each HBS at any time, up to HBS transfer or destruction; (iv) store the HBS under conditions in Tempus’s premises that are secure, clean and appropriate to maintain HBS biological integrity; (v) ensure that its premises have sufficient spare capacity for the storage of chilled and frozen HBS; (vi) The party establish a contingency plan that provides Human Biological Samples required guarantees the quality of stored HBS, including potential refrigerator or freezer malfunction; (vii) monitor HBS storage areas (including refrigerators or freezers used for Xxxxxx’s performance the storage of GSK HBS) in compliance with GSK HBS storage requirements; (viii) implement procedures to ensure that prompt action is taken if acceptable limits are breached; and (ix) document and retain all evidence of its monitoring and actions taken in the Activities certifies that appropriate consent at event of any excursions from the material time has on all occasions been given to the extent by Applicable Law and will be obtained by/from an appropriate Person ranges specified in respect of Human Biological Samples collected, transferred, stored, used and subsequently disposed ofthis Agreement.
Appears in 2 contracts
Samples: Strategic Collaboration Agreement (Tempus AI, Inc.), Strategic Collaboration Agreement (Tempus Labs, Inc.)