Common use of Material Transfer Provisions Clause in Contracts

Material Transfer Provisions. Where the Protocol requires the Participating Organisation to supply Material to the Sponsor this Appendix 4 shall apply. [DELETE IF NOT APPLICABLE] In accordance with the Protocol, the Participating Organisation shall send Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor; The Participating Organisation warrants that all 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 above, the 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 item 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject and the approval of all Regulatory Authorities for the Non-Interventional Study and the Protocol; the Material is handled and stored in accordance with applicable law; the 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 and in accordance with the Non-Interventional Study Subject’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study and the use of human biological material; The Participating Organisation and the Sponsor shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; To the extent permitted by law, the Participating Organisation and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material, or the Sponsor’s nominee as stated in Section 1 above, 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 Participating Organisation or its Personnel, or their failure to comply with the terms of this Agreement; The Sponsor undertakes that, in the event that 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 related to the 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 4; Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000.

Material Transfer Provisions. Where the Protocol Clinical Investigation Plan requires the Participating Organisation Trial Site to supply Material to the Sponsor this Appendix 4 6 shall apply. [DELETE WHOLE APPENDIX IF NOT APPLICABLE] In accordance with the ProtocolClinical Investigation Plan, the Participating Organisation Trial Site shall send Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor; . The Participating Organisation Trial Site warrants that all 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; Clinical Investigation Plan. Subject to Section 2 above, the 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 item Section 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject Clinical Investigation Participant and the approval of all Regulatory Authorities for the Non-Interventional Study Clinical Investigation and the ProtocolClinical Investigation Plan; the Material is handled and stored in accordance with applicable law; the 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 committee, where such approval is required, and in accordance with the Non-Interventional Study SubjectClinical Investigation Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study Clinical Investigation and the use of human biological material; . The Participating Organisation Trial Site and the Sponsor shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; 6. To the extent permitted by law, the Participating Organisation 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, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material, or the Sponsor’s nominee as stated in Section 1 above, 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 Participating Organisation 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 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 related to the Non-Interventional Study Clinical 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 4; 6. Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000Act 2004.

Material Transfer Provisions. Where the Protocol requires the Participating Organisation to supply Material to the Sponsor this Appendix 4 shall apply. [DELETE IF THIS APPENDIXIF NOT APPLICABLE] In accordance with the Protocol, the Participating Organisation shall send Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor; . The Participating Organisation warrants that all Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the ,Statutory Instrument No. 158 of 2006 (Quality and Safety of Human Tissue Act 2004Tissues and Cells) Regulations) and as required by the Protocol; . Subject to Section 2 above, the 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 item 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Clinical Trial Subject and the approval of all Regulatory Authorities for the Non-Interventional Study Clinical Trial and the Protocol; the Material is handled and stored in accordance with applicable law; the 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 and in accordance with the Non-Interventional Study Clinical Trial Subject’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study Clinical Trial and the use of human biological material; . The Participating Organisation and the Sponsor shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; . To the extent permitted by law, the Participating Organisation and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material, or the Sponsor’s nominee as stated in Section 1 above, 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 Participating Organisation or its Personnel, or their failure to comply with the terms of this Agreement; . The Sponsor undertakes that, in the event that 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 related to the Non-Interventional Study 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 4; . Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation or retained for future research shall be destroyed in accordance with withStatutory Instrument No. 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations. Appendix 5 – Equipment and Resources [DELETE IF NOT APPLICABLE] Sponsor-Provided Equipment Sponsor will provide the Human Tissue Xxx 0000.CE-Marked equipment identified below (“Sponsor Equipment”) for use by the Participating Organisation in the conduct or reporting of the Clinical Trial:

Material Transfer Provisions. [DELETE IF NOT APPLICABLE] Where the Protocol requires the Participating Organisation to supply Material to the Sponsor this Appendix 4 shall apply. [DELETE IF NOT APPLICABLE] In accordance with the Protocol, the Participating Organisation shall send Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor; The Participating Organisation warrants that all 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 above, the 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 item Section 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject Participant and the approval of all Regulatory Authorities for the Non-Interventional Study and the Protocol; the Material is handled and stored in accordance with applicable law; the 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 committee, where such approval is required, and provided it is in accordance with the Non-Interventional Study SubjectParticipant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study and the use of human biological material; The Participating Organisation and the Sponsor shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; To the extent permitted by law, the Participating Organisation and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material, or the Sponsor’s nominee as stated in Section 1 above, 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 Participating Organisation or its Personnel, or their failure to comply with the terms of this Agreement; The Sponsor undertakes that, in the event that 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 related to the 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 4; Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000Act 2004.

Material Transfer Provisions. Where the Protocol Clinical Investigation Plan requires the Participating Organisation Trial Site to supply Material to the Sponsor this Appendix 4 6 shall apply. [DELETE IF NOT APPLICABLE] In accordance with the ProtocolClinical Investigation Plan, the Participating Organisation Trial Site shall send Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor; . The Participating Organisation Trial Site warrants that all 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; Clinical Investigation Plan. Subject to Section 2 above, the 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 item 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Clinical Investigation Subject and the approval of all Regulatory Authorities for the Non-Interventional Study Clinical Investigation and the ProtocolClinical Investigation Plan; the Material is handled and stored in accordance with applicable law; the 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 and in accordance with the Non-Interventional Study Clinical Investigation Subject’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study Clinical Investigation and the use of human biological material; . The Participating Organisation Trial Site and the Sponsor shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; 6. To the extent permitted by law, the Participating Organisation 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, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material, or the Sponsor’s nominee as stated in Section 1 above, 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 Participating Organisation 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 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 related to the Non-Interventional Study Clinical 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 4; 6. Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000.

Material Transfer Provisions. Where the Protocol Clinical Investigation Plan requires the Participating Organisation Trial Site to supply Material to the Sponsor or CRO this Appendix 4 6 shall apply. [DELETE WHOLE APPENDIX IF NOT APPLICABLE] In accordance with the ProtocolClinical Investigation Plan, the Participating Organisation Trial Site shall send 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 Participating Organisation Trial Site warrants that all 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; Clinical Investigation Plan. Subject to Section 2 above, the 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 item Section 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject Participant and the approval of all Regulatory Authorities for the Non-Interventional Study Clinical Investigation and the ProtocolClinical Investigation Plan; the Material is handled and stored in accordance with applicable law; the 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 committee, where such approval is required, and in accordance with the Non-Interventional Study SubjectParticipant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study Clinical Investigation and the use of human biological material; . The Participating Organisation Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; 6. To the extent permitted by law, the Participating Organisation 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, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 above, 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 Participating Organisation 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 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 related to the Non-Interventional Study Clinical 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 4; 6. Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000Act 2004. Appendix 7 – Equipment and Resources [DELETE WHOLE APPENDIX IF NOT APPLICABLE] Sponsor / CRO-Provided Equipment ☐
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: No. Equipment Estimated Original Value Depreciation Where applicable, the Sponsor / CRO Equipment will be provided with current records of calibration and electrical safety testing. Sponsor- / CRO-Provided Resources ☐
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: ________________________________________________________ Permitted Uses of Sponsor / CRO Equipment and Sponsor / CRO Resources 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.] Disposition of Sponsor / CRO Equipment and Sponsor / CRO Resources Alternative #1 – Return to Sponsor / CRO (DELETE ENTIRE ALTERNATIVE IF NOT APPLICABLE) 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. Alternative #2 – Return of Sponsor Resources to Sponsor and transfer of Sponsor Equipment to the Trial Site with value included in funding. (DELETE ENTIRE ALTERNATIVE IF NOT APPLICABLE) 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. Alternative #3 – Return of Sponsor / CRO Resources to Sponsor or CRO and purchase of Sponsor / CRO Equipment by Trial Site. (DELETE ENTIRE ALTERNATIVE IF NOT APPLICABLE) 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. Vendor-Provided Equipment or Resources ☐
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: No. Equipment Estimated Original Value Depreciation Permitted Uses of Vendor Property [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. Where the Protocol Clinical Investigation Plan requires the Participating Organisation Trial Site to supply Material to the Sponsor or CRO this Appendix 4 6 shall apply. [DELETE WHOLE APPENDIX IF NOT APPLICABLE] In accordance with the ProtocolClinical Investigation Plan, the Participating Organisation Trial Site shall send 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 Participating Organisation Trial Site warrants that all 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; Clinical Investigation Plan. Subject to Section 2 above, the 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 item Section 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject Participant and the approval of all Regulatory Authorities for the Non-Interventional Study Clinical Investigation and the ProtocolClinical Investigation Plan; the Material is handled and stored in accordance with applicable law; the 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 committee, where such approval is required, and in accordance with the Non-Interventional Study SubjectParticipant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study Clinical Investigation and the use of human biological material; . The Participating Organisation Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; 6. To the extent permitted by law, the Participating Organisation 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, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 above, 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 Participating Organisation 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 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 related to the Non-Interventional Study Clinical 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 4; 6. Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000Act 2004.

Material Transfer Provisions. Where the Protocol Clinical Investigation Plan requires the Participating Organisation Trial Site to supply Material to the Sponsor or CRO this Appendix 4 6 shall apply. [DELETE WHOLE APPENDIX IF NOT APPLICABLE] In accordance with the ProtocolClinical Investigation Plan, the Participating Organisation Trial Site shall send 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 Participating Organisation Trial Site warrants that all 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; Clinical Investigation Plan. Subject to Section 2 above, the 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 item Section 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject Clinical Investigation Participant and the approval of all Regulatory Authorities for the Non-Interventional Study Clinical Investigation and the ProtocolClinical Investigation Plan; the Material is handled and stored in accordance with applicable law; the 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 committee, where such approval is required, and in accordance with the Non-Interventional Study SubjectClinical Investigation Participant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study Clinical Investigation and the use of human biological material; . The Participating Organisation Trial Site and the Sponsor or CRO shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; 6. To the extent permitted by law, the Participating Organisation 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, or of the supply to or the use by any third party to whom the Sponsor or CRO subsequently provides the Material, or the Sponsor’s nominee of the Sponsor or CRO as stated in Section 1 above, 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 Participating Organisation 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 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 related to the Non-Interventional Study Clinical 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 4; 6. Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000Act 2004.

Material Transfer Provisions. [DELETE IF NOT APPLICABLE] Where the Protocol requires the Participating Organisation to supply Material to the Sponsor this Appendix 4 shall apply. [DELETE IF NOT APPLICABLE] In accordance with the Protocol, the Participating Organisation shall send Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor; The Participating Organisation warrants that all 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 above, the 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 item Section 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject Participant and the approval of all Regulatory Authorities for the Non-Interventional Study and the Protocol; the Material is handled and stored in accordance with applicable law; the 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 committee, where such approval is required, and provided it is in accordance with the Non-Interventional Study SubjectParticipant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study and the use of human biological material; The Participating Organisation and the Sponsor shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; To the extent permitted by law, the Participating Organisation and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material, or the Sponsor’s nominee as stated in Section 1 above, 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 Participating Organisation or its Personnel, or their failure to comply with the terms of this Agreement; The Sponsor undertakes that, in the event that 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 related to the 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 4; Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000Act 2004.

Material Transfer Provisions. Where the Protocol requires the Participating Organisation to supply Material to the Sponsor this Appendix 4 shall apply. [DELETE IF NOT APPLICABLE] In accordance with the Protocol, the Participating Organisation shall send Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor; The Participating Organisation warrants that all 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 above, the 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 item 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject and the approval of all Regulatory Authorities for the Non-Interventional Study and the Protocol; the Material is handled and stored in accordance with applicable law; the 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 and in accordance with the Non-Interventional Study Subject’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study and the use of human biological material; The Participating Organisation and the Sponsor shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; To the extent permitted by law, the Participating Organisation and its Personnel shall not be liable for any consequences of the supply to or the use by the Sponsor of the Material, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material, or the Sponsor’s nominee as stated in Section 1 above, 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 Participating Organisation or its Personnel, or their failure to comply with the terms of this Agreement; The Sponsor undertakes that, in the event that 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 related to the 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 4; Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000Act 2004.

Material Transfer Provisions. Where the Protocol Clinical Investigation Plan requires the Participating Organisation Trial Site to supply Material to the Sponsor this Appendix 4 6 shall apply. [DELETE WHOLE APPENDIX IF NOT APPLICABLE] In accordance with the ProtocolClinical Investigation Plan, the Participating Organisation Trial Site shall send Material to the Sponsor or, in accordance with Section 7 below, to a third party nominated by the Sponsor; . The Participating Organisation Trial Site warrants that all 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; Clinical Investigation Plan. Subject to Section 2 above, the 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 item Section 1 above, that: the Material is used in accordance with the consent of the Non-Interventional Study Subject Participant and the approval of all Regulatory Authorities for the Non-Interventional Study Clinical Investigation and the ProtocolClinical Investigation Plan; the Material is handled and stored in accordance with applicable law; the 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 committee, where such approval is required, and in accordance with the Non-Interventional Study SubjectParticipant’s consent. The Parties shall comply with all relevant laws, regulations and codes of practice governing the Non-Interventional Study Clinical Investigation and the use of human biological material; . The Participating Organisation Trial Site and the Sponsor shall each be responsible for keeping a record of the Material that has been transferred according to this Appendix 4; 6. To the extent permitted by law, the Participating Organisation 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, or of the supply to or the use by any third party to whom the Sponsor subsequently provides the Material, or the Sponsor’s nominee as stated in Section 1 above, 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 Participating Organisation 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 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 related to the Non-Interventional Study Clinical 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 4; 6. Unless otherwise agreed, any surplus Material that is not returned to the Participating Organisation Trial Site or retained for future research shall be destroyed in accordance with the Human Tissue Xxx 0000Act 2004.