HUMAN SAMPLES Sample Clauses

HUMAN SAMPLES. As part of the Protocol, Samples derived from Clinical Study Subjects may be transferred to Sponsor or another organization indicated by Sponsor (hereinafter: “Sponsor’s Designee”), however only if this is arranged for in the ICF. If this done in non-anonymous form, Sponsor and Sponsor’s Designee shall adhere to the provisions of the GDPR by concluding an industry standard processor agreement with each other.
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HUMAN SAMPLES. “Human Samples” means human biological material, including any portion of any tissue, blood, cerebrospinal fluid, cells or sub-cellular structures such as DNA, or any derivative of such human biological material such as pathogens (bacteria, viruses, fungi, parasites), serum, stem cells, cell lines and any human biological product. Access to, provision and exchange of Human Samples under the Project shall be carried out pursuant to the terms of this Consortium Agreement, any Study Protocols and the following principles: only Parties that are [hospitals //or// university/university hospital] shall be allowed to permanently store Human Samples. Collected Human Samples will be aliquoted (split) into fragments of the original sample at the microbiology institutions of each Party that is a [university/university hospital]. One aliquot will be shipped to the Party/ies performing examinations such as sequencing and metabolomics as described in the Project Description and/or the respective Study Protocol. Leftover aliquots will be stored at each microbiology institution for at least 5 years; Human Samples shall not be disposed of or acquired as such for research purposes in return for payment or other non-cash advantage. However, the foregoing shall not apply to operations such as preparation, transport, storage etc. of Human Samples; The Parties may only use the Human Samples received under this Consortium Agreement for the Project and shall either return or destroy the Human Samples after the related activities to the providing Party, or if requested by the patient.
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HUMAN SAMPLES. As part of the Protocol, Samples may be transferred to Sponsor or another organization indicated by Sponsor only if this is arranged for in the ICF. Sponsor, and the other organization mentioned above in this clause 18.1, shall have the right to store, transfer and use the Samples only in accordance with the applicable Law, the Protocol and ICF (as approved by the ethics committee). Principal Investigator shall promptly notify Sponsor of any withdrawal of or changes in the informed consent of a Clinical Trial Subject, which may affect the use of such Clinical Trial Subject’s Samples under this Agreement. In such event, Sponsor shall destroy or return the affected Samples if necessary. Upon termination or expiration of the Clinical Trial, and at least at any time the Samples are no longer needed to be retained by Sponsor for any pending registration purpose related to the Study Drug in relation to the Protocol or as defined in the ICF, or as required per any Applicable Law or regulation, the remainder of the Samples in Sponsor’s or any of its designee’s possession will be returned to the Site Parties, retained by the Sponsor in accordance with clause 18.2 or destroyed by the Sponsor, as described in the Protocol and/or the ICF. For the avoidance of any doubt, the control (in Dutch: zeggenschap) of the Samples remains at all times at the Clinical Trial Subjects they are derived from, with the Institution and/or Sponsor acting as custodian of the Samples, as described in the Protocol.
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HUMAN SAMPLES. 18.1 As part of the Protocol, Samples may be transferred to Sponsor or another organization indicated by Sponsor only if this is arranged for in the ICF. 18.2 Sponsor, and the other organization mentioned above in this clause 18.1, shall have the right to store, transfer and use the Samples only in accordance with the applicable Law, the Protocol and ICF (as approved by the ethics committee). Principal Investigator shall promptly notify Sponsor of any withdrawal of or changes in the informed consent of a Clinical Trial Subject, which may affect the use of such Clinical Trial Subject’s Samples under this Agreement. In such event, Sponsor shall destroy or return the affected Samples if necessary. 18.3 Upon termination or expiration of the Clinical Trial, and at least at any time the Samples are no longer needed to be retained by Sponsor for any pending registration purpose related to the Study Drug in relation to the Protocol or as defined in the ICF, or as required per any Applicable Law or regulation, the remainder of the Samples in Sponsor’s or any of its designee’s possession will be returned to the Site Parties, retained by the Sponsor in accordance with clause 18.2 or destroyed by the Sponsor, as described in the Protocol and/or the ICF. 18.4 For the avoidance of any doubt, the control (in Dutch: zeggenschap) of the Samples remains at all times at the Clinical Trial Subjects they are derived from, with the Institution and/or Sponsor acting as custodian of the Samples, as described in the Protocol.
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HUMAN SAMPLES. All human samples collected and retained in connection with Clinical Studies involving a Licensed Antibody or Licensed Product that are performed under a Development Plan and Budget or for which costs are shared as Allowable Expenses (together with compilations of Information comprising annotations regarding patient histories or correlating patient outcomes, with respect to such samples, the “Human Samples”) shall be a shared resource of the Parties. Unless otherwise agreed by the Parties, all Human Samples shall be maintained and stored at the facilities of a Third Party reasonably agreed by the Parties, and the fees paid to such Third Party in connection with such maintenance and storage shall be shared equally by the Parties. Each Party shall access and use the Human Samples, and authorize Affiliates and Third Parties to access or use the Human Samples, outside of the Collaboration Programs only as reasonably agreed by the Parties. If the Parties are unable to reach agreement on the storage, access to or use of the Human Samples, the matter shall be determined pursuant to Section 13.7.4 below. Notwithstanding anything herein to the contrary, the Parties agree that in no case shall either Party propose any access or use of the Human Samples which would (1) conflict with the terms of the informed consent under which the relevant Patient Sample was collected or (2) violate Applicable Law. Either Party shall have the right to access such samples in connection with such Party’s performance of its Party Development Activities.
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HUMAN SAMPLES. The Beneficiaries must use Human Samples under and pursuant to this Consortium Agreement and the Grant Agreement in compliance with their respective obligations under applicable international and national laws and regulations.
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HUMAN SAMPLES. The use of Samples derived from Clinical Study subjects shall be exclusively governed by the Consortium Agreement. Annex 1: Protocol Annex 2: Financial Provisions Annex 3: Equipment Annex 4: Consortium Agreement and Grant Agreement Annex 5: Data Processing Agreement Name xxxxxxx Name xxxxxxxxxxxxxxxxxxxx Title xxx Title xxxxxxxxxxxxxxxxxxxx Place, Country Czech republic (location) Place, Country Zeist, Netherlands (location) Date Date Signed by the Site Investigator: Name xxxxxxxxxxxxx Title Place, Country (location) Date (the most recent version of the Protocol has been incorporated by reference only)
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HUMAN SAMPLES. Not applicable
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HUMAN SAMPLES. The Beneficiaries must use Human Samples under and pursuant to this Consortium Agreement and the Grant Agreement in compliance with their respective obligations under applicable international and national laws and regulations. Human Samples - representation and warranty. Each Beneficiary represents and warrants that any Human Samples required for use in the Project that are obtained, handled or used by it (i) will be obtained, handled or used in accordance with all relevant laws and regulations (and where applicable, local ethical guidelines) regarding the collection, use, transport and subsequent disposal of Human Samples and (ii) that any ethics committee approvals and Donor informed consents – in so far needed - required for performing the Action or to conduct Research Use pursuant to the provisions of the Consortium Agreement (or otherwise determined in a bilateral agreement between the Human Sample provider and the Human Sample receiver), will be obtained prior to the commencement of the respective part of the Allocated Work respectively the envisaged Research Use. When processing Personal Data in relation to Human Samples under or pursuant to the Grant Agreement and/or this Consortium Agreement, the relevant Beneficiaries will comply with the terms and conditions as set out in Appendix 3. Data agreements. The relevant Beneficiaries may need to enter into appropriate additional agreements (e.g. data processing and/or data transfer agreements), to implement, regulate and facilitate appropriate provisions on the transfer and processing of data (including Personal Data) in relation to the Project, including the case being data transfers of data to a database/platform or biobank within the Project. The draft of such additional agreements shall in such case be initiated by the Beneficiary providing the data to another Beneficiary/Third Party (data receiver), regardless of the status of the Beneficiary providing the data per applicable Data Protection Legislation, before the transfer or processing of such data actually occurs, unless agreed otherwise in writing and beforehand between the data provider and data receiver or otherwise covered in the Data Management Plan. Such agreements may not contain provisions contradicting this Consortium Agreement (including the provisions of Appendix 3 to the extent and in so far applicable) or limiting any usage rights already granted under this Consortium Agreement, and are subject to applicable Data Protection Legisla...
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