King’s Health Partners Cancer Biobank 

Terms & Conditions - MAY 2013 v2.0

 

The King’s Health Partners Cancer Biobank collects, stores and distributes tissues and associated data for the purposes of research into the cause, diagnosis and treatment of disease. The resource is accessible to investigators from Kings Health Partners, other academic institutions and commercial companies.

 

King’s Health Partners Cancer Biobank uses cost recovery models for academic and commercial companies whereby investigators will be charged the cost of sample processing, preparation and transport and contribute to the cost of collection and storage of Materials.

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Supply And Use Of Materials

King’s Health Partners Cancer Biobank (also referred to as "Custodian") agrees to supply samples and / or data ("the Materials") from its King’s Health Partners’ custodian to the Recipient Institution upon the following Terms and Conditions and in accordance with the Custodian's data/sample access policy (as may be reasonably amended by the Custodian from time to time)

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In the event of any conflict between these Terms and Conditions and any Materials Transfer Agreement (MTA) that may be entered into between a King’s Health Partner and the Recipient, the terms of the Materials Transfer Agreement shall prevail.

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The Materials and any unmodified derivatives thereof (and all rights therein) shall at all times remain the property of its custodian.

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The Custodian shall supply the Materials to the Recipient in a manner and format as defined in the approved study application.

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The Recipient shall pay the cost of retrieving, processing, packaging and dispatching the Materials from the Custodian to the Recipient as well as sample collection and storage under the applicable costing model.

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The Recipient shall use the Materials solely for the purpose of the approved Study for which the Materials are transferred and always in accordance with good laboratory practice.

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The Recipient shall NOT distribute, sell, transfer or release the Materials supplied by the Custodian to any third party, nor use the Tissue Sample(s) in human subjects or in clinical trials or for diagnostic purposes involving humans nor expose the Tissue Sample(s) to any material to be administered to or consumed by any human.

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The Recipient shall maintain accurate, full, clear and up-to-date records of research, tests, results and other work carried out in connection with the Study and ensure compliance with any and all applicable laws and regulations governing the transportation, keeping or use of the Materials including but not limited to the Human Tissue Act (2004), in force from time to time.

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The Recipient shall ensure that the samples are handled as a potential biohazard. The associated risks shall not be the responsibility of the custodian. The Recipient shall also dispose or return the Materials upon study termination or consent withdrawal.

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Data Protection

The Custodian confirms that it intends to provide all Clinical Data and Tissue Samples to the Recipient in anonymised or pseudoanonymised form. The Recipient shall adhere to the Data Protection Act 1998 and equivalent applicable laws and not attempt to relate Materials or Study results or other details to identifiable individuals.

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If Personal Data (as defined under the Data Protection Act 1998) is inadvertently transferred to the Recipient, the Recipient undertakes to inform the Custodian as soon as possible that it is in possession of such Personal Data and only process such Personal Data in accordance with the Data Protection Act 1998 and make no independent use of it whatsoever and to act at all times in accordance with the Custodians’ reasonable instructions and requirements including destroying any personal identifiers or such Personal Data should the Custodian so require.

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“Confidential Information” shall mean any information and data (of whatever nature and however recorded or preserved) that is confidential in nature relating to either Party, its patients and Material (including Clinical Data), business or activities, and which is disclosed by one Party (the “Disclosing Party”), its representatives, or advisers to the other Party (“Receiving Party) or its representatives or advisers. The Receiving Party undertakes to the Disclosing Party to:

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• Keep secret and confidential the Confidential Information; and

• Use the Confidential Information solely for the purpose of the Study; and

• Not disclose the Confidential Information of the Disclosing Party to any of Receiving Party’s personnel except to those who “need to know” to perform the Study (which in the case of the Recipient, shall mean the Investigator and any Co-workers only), and the Receiving Party shall procure that such persons to whom disclosure has been made are similarly bound; and

• Not disclose the Confidential Information to any third party without the prior written permission of the Disclosing Party.

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The obligations of confidence referred to shall not extend to any information which: (i) is or becomes generally available to the public other than as a result of disclosure by the Receiving Party (or its representatives or advisers) contrary to their respective obligations of confidentiality; or (ii) is or becomes available to the Receiving Party otherwise than pursuant to this Agreement and free of any restriction as to its use or disclosure; or (iii) is required by law, regulation or order of a competent authority (including any regulatory or governmental body or securities exchange) to be disclosed by the Receiving Party.

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Nothing shall restrict, delay, or prevent a Party from making disclosures under the Freedom of Information Act 2000, in force from time to time.

 

Publication And Intellectual Property

Nothing in this Agreement shall affect the ownership of intellectual property rights or other material or information existing prior to any transfer of Material (“Background”). The Custodian retains ownership of any Material, unmodified derivatives of the Material or Background which are embedded or contained in any Foreground (as defined below) as well as any modifications of the Custodians’ datasets, designs, images or databases made by Recipient that have been supplied as Background.

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Excluding Background, any and all intellectual property rights arising from use of the Material developed in whole or in part by any Party (‘Foreground’), shall belong to the Party creating such, or shall be owned by a Party or Parties as otherwise agreed under any relevant Collaboration Agreement or MTA where the King’s Health Partner Custodian and the Recipient are collaborators under a Study.

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Where the Recipient owns the Foreground, it hereby grants to King’s Health Partners the right to use the Foreground for teaching and non-commercial research and patient care purposes only, but for no other purpose, without the prior written consent of Recipient.

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Notwithstanding the foregoing, King’s Health Partners may publish or present the results arising from the use of the Materials and the associated Foreground, provided such publication or presentation does not disclose Recipient Confidential Information.

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King’s Health Partners shall submit for review a copy of the proposed publication (including abstracts, or presentation to a journal, editor, meeting, seminar or other third party) to Recipient at least sixty (60) days prior to submission for publication or presentation.  If Recipient determines that the proposed publication or presentation contains patentable subject matter and/or any of its Confidential Information, Recipient may require King’s Health Partners to delay the publication or presentation for a period of time not to exceed ninety (90) days for the purpose of deleting such confidential information and/or filing appropriate patent applications.

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Recipient shall acknowledge ‘King’s Health Partners Cancer Biobank’ on all publications, presentations or promotional material that has used Materials supplied by the Custodian.

 

Recipient agrees that the study title, lay summary and institutional details can be published on the Custodian’s website

 

Warranties And Liabilities

Nothing in these terms and conditions shall exclude or limit any Party’s liability for any death or personal injury caused by its negligence, nor for any fraudulent misrepresentation.

The Materials are provided ‘as is’ and the Custodian makes no representation and gives no warranty or undertaking whatsoever in relation to the Materials including but not limited to merchantability or fitness for a particular purpose, or that the use of the Materials will not infringe any patent, copyright, trademark, or other proprietary rights.  The Custodian does not warrant that the Material is free of extraneous agents, or biologically active contaminants, which may be present in any Materials.

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To the extent permitted by applicable law Recipient agrees to indemnify and hold harmless the Custodian against any claims resulting from Recipient’s use or storage of the Materials and the Custodian shall not be liable in contract, tort or otherwise for any direct, indirect or consequential loss or damage sustained by the Recipient in its use, storage or handling of the Material or its use of the Foreground (whether in the Study or otherwise).