Common use of Material Transfer Provisions Clause in Contracts

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol requires the Trial Site to supply Material and / or Starting Material to the Sponsor this Appendix 6 shall apply. In accordance with the Protocol, the Trial Site shall send Material and / or Starting Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the Protocol. Subject to Section 2 of this Appendix, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor shall ensure, or procure through an agreement with the Sponsor’s nominee as stated in Section 1 of this Appendix, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial and the Protocol; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial and the use of Material. The Trial Site and the Sponsor shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendix, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee as stated in Section 1 of this Appendix, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol Clinical Investigation Plan requires the Trial Site to supply Material and / or Starting Material to the Sponsor this Appendix 6 shall apply. In accordance with the ProtocolClinical Investigation Plan, the Trial Site shall send Material and / or Starting Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the ProtocolClinical Investigation Plan. Subject to Section 2 of this Appendixabove, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor shall ensure, or procure through an agreement with the Sponsor’s nominee as stated in Section 1 of this Appendixabove, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial Investigation and the ProtocolClinical Investigation Plan; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol Clinical Investigation Plan or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial Investigation and the use of Materialhuman biological material. The Trial Site and the Sponsor shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendixlaw, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee as stated in Section 1 of this Appendixabove, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial Investigation in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.. Appendix 7 – Equipment and Resources ☐
Please check this box if no Equipment, other than the medical device that is the subject of the Clinical Investigation, will be provided by the Sponsor Sponsor will provide the CE-Marked equipment identified below (“Sponsor Equipment”) for use by the Trial Site in the conduct or reporting of the Clinical Investigation:

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol requires the Trial Site to supply Material and / or Starting Material to the Sponsor this Appendix 6 shall apply. In accordance with the Protocol, the Trial Site shall send Material and / or Starting Material to the Sponsor or, in accordance with Section 7 belowof this Appendix, to a third party nominated by the Sponsor. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the Protocol. Subject to Section 2 of this Appendix, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor shall ensure, or procure through an agreement with the Sponsor’s nominee as stated in Section 1 of this Appendix, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial and the Protocol; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial and the use of Material. The Trial Site and the Sponsor shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendix, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee as stated in Section 1 of this Appendix, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 aboveof this Appendix, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol Clinical Investigation Plan requires the Trial Site to supply Material and / or Starting Material to the Sponsor this Appendix 6 shall apply. In accordance with the ProtocolClinical Investigation Plan, the Trial Site shall send Material and / or Starting Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the ProtocolClinical Investigation Plan. Subject to Section 2 of this Appendixabove, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor shall ensure, or procure through an agreement with the Sponsor’s nominee as stated in Section 1 of this Appendixabove, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial Investigation and the ProtocolClinical Investigation Plan; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol Clinical Investigation Plan or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial Investigation and the use of Materialhuman biological material. The Trial Site and the Sponsor shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendixlaw, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee as stated in Section 1 of this Appendixabove, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial Investigation in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 4 (Material Transfer Provisions) is not used. Where the Protocol requires the Trial Site Participating Organisation to supply Material and / or Starting Material to the Sponsor or CRO this Appendix 6 4 shall apply. In accordance with the Protocol, the Trial Site Participating Organisation shall send Material and / or Starting Material to the Sponsor Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the Sponsor. Sponsor or CRO; The Trial Site Participating Organisation warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the Protocol. ; Subject to Section 2 of this Appendixabove, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. ; The Sponsor or CRO shall ensure, or procure through an agreement with the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial Non-Interventional Study and the Protocol; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial Non-Interventional Study and the use of Material. ; The Trial Site Participating Organisation and the Sponsor or CRO shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. 4; To the extent permitted by law and set forth in accordance with Section 5 of this Appendixlaw, the Trial Site Participating Organisation and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor or CRO of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site Participating Organisation or its Personnel, or their failure to comply with the terms of this Agreement. ; The Sponsor and / or CRO undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial Non-Interventional Study in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. 4; Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site Participating Organisation or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol requires the Trial Site to supply Material and / or Starting Material to the Sponsor this Appendix 6 shall apply. used In accordance with the ProtocolClinical Investigation Plan, the Trial Site shall send Material and / or Starting Material to the Sponsor Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the SponsorSponsor or CRO. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the ProtocolClinical Investigation Plan. Subject to Section 2 of this Appendixabove, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor or CRO shall ensure, or procure through an agreement with the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial Investigation and the ProtocolClinical Investigation Plan; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol Clinical Investigation Plan or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial Investigation and the use of Material. The Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendixlaw, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor or CRO of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor and / or CRO undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial Investigation in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol Clinical Investigation Plan requires the Trial Site to supply Material and / or Starting Material to the Sponsor or CRO this Appendix 6 shall apply. In accordance with the ProtocolClinical Investigation Plan, the Trial Site shall send Material and / or Starting Material to the Sponsor Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the SponsorSponsor or CRO. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the ProtocolClinical Investigation Plan. Subject to Section 2 of this Appendixabove, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor or CRO shall ensure, or procure through an agreement with the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial Investigation and the ProtocolClinical Investigation Plan; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol Clinical Investigation Plan or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial Investigation and the use of Materialhuman biological material. The Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendixlaw, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor or CRO of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor and / or CRO undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial Investigation in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004. Appendix 7 – Equipment and Resources ☐
Please check this box if no Equipment, other than the medical device that is the subject of the Clinical Investigation, will be provided by the Sponsor or CRO Sponsor or CRO will provide the CE-Marked equipment identified below (“Sponsor / CRO Equipment”) for use by the Trial Site in the conduct or reporting of the Clinical Investigation: Where applicable, the Sponsor / CRO Equipment will be provided with current records of calibration and electrical safety testing. ☐
Please check this box if no Resources will be provided by the Sponsor or CRO Sponsor or CRO will provide the Sponsor or CRO owned or licensed proprietary resources identified below (“Sponsor / CRO Resources”) for use by the Trial Site in the conduct or reporting of the Clinical Investigation. Sponsor / CRO Resources Supplied: ________________________________________________________ The Trial Site may use Sponsor / CRO Equipment and Sponsor / CRO Resources only for the purpose of this Clinical Investigation. [Alternatively, specify permitted uses. If use for non-Participants is permitted for Equipment, specify that (1) a charge will be assessed (deducted from Clinical Investigation funding) based on estimated or actual usage or (2) the Trial Site agrees that use of the Equipment for non-Participants will not be charged to the patient or third-party payer. Non-Clinical Investigation use of Sponsor Resources is generally not permitted.] After completion of the Clinical Investigation at the Investigator Site, or at an earlier time specified by Sponsor or CRO, the Sponsor or CRO will contact the Trial Site to make arrangements for return of any [Sponsor / CRO Equipment] [and] [Sponsor / CRO Resources], at the expense of the Sponsor or CRO, to the Sponsor or CRO or a location designated by Sponsor or CRO. The Trial Site’s responsibilities under this Agreement for the [Sponsor / CRO Equipment] [and] [Sponsor / CRO Resources] will cease or transfer to the Sponsor or CRO at the time of removal from the Trial Site. After completion of the Clinical Investigation at the Investigator Site, or at an earlier time specified by Sponsor or CRO, the Sponsor or CRO will contact the Trial Site to make arrangements for return of any [Sponsor / CRO Equipment] [and] [Sponsor / CRO Resources], at the expense of the Sponsor or CRO, to the Sponsor or CRO or a location designated by Sponsor or CRO. The Trial Site’s responsibilities under this Agreement for the [Sponsor / CRO Equipment] [and] [Sponsor / CRO Resources] will cease or transfer to the Sponsor or CRO at the time of removal from the Trial Site. The total compensation for Clinical Investigation conduct allocated to the Trial Site has been calculated to include the estimated depreciated value of Sponsor / CRO Equipment at the termination of this Agreement. The Sponsor or CRO will transfer title or arrange for transfer of title in Sponsor / CRO Equipment to the Trial Site at the termination of this Agreement, provided that the Trial Site (through the Principal Investigator) has enrolled the targeted number of Participants (or some other number of Participants agreeable to the Sponsor and CRO), has complied with the terms of the Agreement and has satisfactorily completed all Clinical Investigation Plan requirements. The Sponsor or CRO will ensure that this transfer is documented in writing and the Parties hereby acknowledge and agree that the estimated depreciated value of Sponsor / CRO Equipment at termination of this Agreement is part of the total compensation payable for Clinical Investigation conduct. If any Sponsor / CRO Equipment is so transferred, it will be transferred ‘as is’ and neither the Sponsor nor the CRO makes any representation or provides any warranty of any kind concerning it. After completion of the Clinical Investigation at the Investigator Site, or at an earlier time specified by Sponsor or CRO, the Sponsor or CRO will contact the Trial Site to make arrangements for return of any [Sponsor / CRO Equipment] [and] [Sponsor / CRO Resources], at the expense of the Sponsor or CRO, to the Sponsor or CRO or a location designated by Sponsor or CRO. The Trial Site’s responsibilities under this Agreement for the [Sponsor / CRO Equipment] [and] [Sponsor / CRO Resources] will cease or transfer to the Sponsor or CRO at the time of removal from the Trial Site. After completion of the Clinical Investigation at the Investigator Site, Sponsor or CRO will make Sponsor / CRO Equipment available for purchase by the Trial Site at its then depreciated value. If Clinical Investigation conduct is completed significantly earlier or later than originally estimated, the depreciated value identified in the table above will be adjusted accordingly. The Sponsor or CRO will ensure that any transfer of ownership is documented in writing. If any Sponsor / CRO Equipment is so transferred, it will be transferred ‘as is’ and neither the Sponsor nor the CRO makes any representation or provides any warranty of any kind concerning it. ☐
Please check this box if no Equipment or Resources will be provided by a Vendor The Sponsor or CRO will arrange for a vendor to provide the following equipment or proprietary materials (“Vendor Property”) for use in this Clinical Investigation: [OPTION 1 (delete if not applicable): The Trial Site will use Vendor Property only for purposes of this Clinical Investigation.] [OPTION 2 (delete if not applicable): Specify permitted uses.]

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol requires the Trial Site to supply Material and / or Starting Material to the Sponsor or CRO this Appendix 6 shall apply. In accordance with the Protocol, the Trial Site shall send Material and / or Starting Material to the Sponsor Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the SponsorSponsor or CRO. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the Protocol. Subject to Section 2 of this Appendix, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor or CRO shall ensure, or procure through an agreement with the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendix, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial and the Protocol; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial and the use of Material. The Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendix, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor or CRO of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendix, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor and / or CRO undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol Clinical Investigation Plan requires the Trial Site to supply Material and / or Starting Material to the Sponsor or CRO this Appendix 6 shall apply. In accordance with the ProtocolClinical Investigation Plan, the Trial Site shall send Material and / or Starting Material to the Sponsor Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the SponsorSponsor or CRO. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the ProtocolClinical Investigation Plan. Subject to Section 2 of this Appendixabove, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor or CRO shall ensure, or procure through an agreement with the Sponsor’s nominee of the Sponsor or CRO as stated in Section item 1 of this Appendixabove, that: the Material and / or Starting Material is used in accordance with the consent of the Participant Clinical Investigation Subject and the approval of all Regulatory Authorities for the Clinical Trial Investigation and the ProtocolClinical Investigation Plan; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol Clinical Investigation Plan or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, committee and provided it is in accordance with the ParticipantClinical Investigation Subject’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial Investigation and the use of Materialhuman biological material. The Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendixlaw, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor or CRO of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor and/or undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial Investigation in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004▇▇▇ ▇▇▇▇.

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol Clinical Investigation Plan requires the Trial Site to supply Material and / or Starting Material to the Sponsor or CRO this Appendix 6 shall apply. In accordance with the ProtocolClinical Investigation Plan, the Trial Site shall send Material and / or Starting Material to the Sponsor Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the SponsorSponsor or CRO. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the ProtocolClinical Investigation Plan. Subject to Section 2 of this Appendixabove, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor or CRO shall ensure, or procure through an agreement with the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, that: the Material and / or Starting Material is used in accordance with the consent of the Participant and the approval of all Regulatory Authorities for the Clinical Trial Investigation and the ProtocolClinical Investigation Plan; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol Clinical Investigation Plan or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial Investigation and the use of Materialhuman biological material. The Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendixlaw, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor or CRO of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor and / or CRO undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial Investigation in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.

Material Transfer Provisions. ☐
If this box is checked, this Appendix 6 (Material Transfer Provisions) is not used. Where the Protocol Clinical Investigation Plan requires the Trial Site to supply Material and / or Starting Material to the Sponsor or CRO this Appendix 6 shall apply. In accordance with the ProtocolClinical Investigation Plan, the Trial Site shall send Material and / or Starting Material to the Sponsor Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the SponsorSponsor or CRO. The Trial Site warrants that all Material and / or Starting Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the ProtocolClinical Investigation Plan. Subject to Section 2 of this Appendixabove, the Material and / or Starting Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor or CRO shall ensure, or procure through an agreement with the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, that: the Material and / or Starting Material is used in accordance with the consent of the Clinical Investigation Participant and the approval of all Regulatory Authorities for the Clinical Trial Investigation and the ProtocolClinical Investigation Plan; the Material and / or Starting Material is handled and stored in accordance with applicable law; the Material and / or Starting Material shall not be redistributed or released to any person other than in accordance with the Protocol Clinical Investigation Plan or for the purpose of undertaking other research approved by an appropriate ethics committee, where such approval is required, and provided it is in accordance with the Clinical Investigation Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Clinical Trial Investigation and the use of Materialhuman biological material. The Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material and / or Starting Material that has been transferred according to this Appendix 6. To the extent permitted by law and set forth in accordance with Section 5 of this Appendixlaw, the Trial Site and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor or CRO of the Material and / or Starting Material, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material and / or Starting Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 of this Appendixabove, save to the extent that any liability that arises is a result of the negligence, wrongful acts or omissions or breach of statutory duty of the Trial Site or its Personnel, or their failure to comply with the terms of this Agreement. The Sponsor and / or CRO undertakes that, in the event that Material and / or Starting Material is provided to a third party in accordance with Section 1 above, it shall require that such third party shall undertake to handle any Material and / or Starting Material related to the Clinical Trial Investigation in accordance with all applicable statutory requirements and codes of practice and under terms no less onerous than those set out in this Appendix 6. Unless otherwise agreed, any surplus Material and / or Starting Material that is not returned to the Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Act 2004.