Human Biological Samples Sample Clauses
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Human Biological Samples. 14.23.1 Each of the Parties represents, warrants and undertakes to other that any human biological samples used in the Research Collaboration have been and shall be obtained, and shall be stored and used, in accordance with all relevant laws including, but not limited to, the Human Tissue Act 2004 and any generally accepted ethical guidelines in particular the MRC Guidelines entitled “Human Tissue and Biological Samples for use in Research” regarding the collection, use and transport of human tissue.
14.23.2 Each of the Parties represents, warrants and undertakes to the other that all the relevant ethics committee approvals have been and shall be obtained to enable the use of any human biological samples obtained from patients or human subject volunteers or other donors in the Research Collaboration under this Agreement.
14.23.3 Each of the Parties represents, warrants and undertakes to the other that all uses of any human biological samples in the Research Collaboration fall and shall fall within the terms of the informed consent given by the donors of the samples including without limitation transfer to, and use by, a commercial organisation of the human biological samples and associated personal information in anonymised or coded form.
Human Biological Samples. If the Parties wish to source Human Biologicals Samples on each other’s behalf or exchange Human Biological Samples between them, such exchange shall be recorded in separate addendums to this Agreement setting forth further terms and conditions for the specific purpose. GSK and CureVac undertake that the Human Biological Samples used or collected in connection with the Development have been obtained and will be stored, transferred, used and disposed of in accordance with all Applicable Laws and any generally accepted ethical guidelines regarding the collection, use, transport and disposal of human tissue, including with regard to consents from patients, volunteers and other donors.
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 ...
Human Biological Samples. If the Study includes the collection by Institution of human biological materials from Study Subjects for research use, Institution will comply with all applicable laws, rules, regulations and codes of practice and guidance relating to the collection, storage, use, shipping, and disposal of human biological materials in the conduct of the Study and with respect to any such human biological materials from the Study retained in Institution’s possession. Institution agrees to appropriate informed consent (including, as appropriate, for any genetic analyses) for the Study and for research use of any human biological materials, with ethics approval. Site agrees that any human biological materials collected as part of the Study that are transferred to GSK or a GSK’s contractor, or held by Institution for GSK, will be under the custodianship and control of GSK.
Human Biological Samples. Supplier recognizes AstraZeneca’s commitment to working only with suppliers who embrace standards of ethical behavior that are consistent with AstraZeneca’s Global Policy on Bioethics, which can be found at: ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/content/dam/az/ourcompany/Sustainability/Bioethics-Policy-v60.pdf Supplier represents, warrants and undertakes that it shall perform the Services and operate its business in a manner which is consistent with said policy.
Human Biological Samples. The Human Biological Samples transferred to GSK by Surface in the course of the Technical Transition Services have been obtained and will be stored, transferred, used and disposed of in accordance with all applicable Laws and any generally accepted ethical guidelines regarding the collection, use, transport and disposal of human tissue. All the relevant ethics committee approvals and informed consents have been obtained to enable the use of the Human Biological Samples obtained from patients or human subject volunteers or other donors in the Development or Manufacture of Licensed Antibodies. No human embryonic or fetal derived material (including cell lines) have been or will be used in connection with the Technical Transition Services or other Development or Manufacture of Licensed Antibodies, without the express prior written approval of GSK.
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...
