Common use of HUMAN SAMPLES Clause in Contracts

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.

Appears in 2 contracts

Samples: Trial Agreement, Trial Agreement

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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 Committeeethics 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 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.

Appears in 2 contracts

Samples: Trial Agreement, Trial Agreement

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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 Committeeethics 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 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 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.

Appears in 1 contract

Samples: Trial Agreement

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