Common use of Transfer of Materials Clause in Contracts

Transfer of Materials. In the event of early termination of this Agreement in accordance with Section 12.2 ( c ) above: (i) to the extent not transferred pursuant to Section 12.3(a), Licensee shall provide to Licensor a copy of any and all documentation and data owned by Licensee and in tangible form at the time of termination of the Agreement that has been generated with respect to the Licensed Product and is necessary to enable Licensor to continue development of a Licensed Product and the commercialization thereof in the Territory (collectively, the “Licensee Product Data”), and Licensor may use such Licensee Product Data at its discretion on an exclusive basis, to the extent necessary to enable Licensor, its Affiliates and Third Parties on behalf of Licensor or its Affiliates to continue to develop and commercialize a Licensed Product in the Territory; and (ii) if such termination occurs after a Licensed Product has received Regulatory Approval, Licensee shall, if permitted under applicable Law, promptly transfer and deliver to Licensor original copies of any and all Regulatory Approvals obtained in connection with the Licensed Product in the Territory (including any and all official registrations, licenses, permits, certificates, and/or importation documents issued by Regulatory Authorities in the Territory), as well as any and all regulatory documentation and applications for Regulatory Approval submitted to Regulatory Authorities in the Territory in connection with the Licensed Product; Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(ii); and (iii) to the extent that any Regulatory Approval is issued in the name of Licensee, its Affiliates, Sublicensees or other designee, Licensee shall, to the extent permitted by applicable Law, promptly assign or procure the assignment to Licensor (or its designee) such Regulatory Approvals, and in the event assignment is not permitted under applicable Law or cannot be carried out for any other reason, the Licensee shall take all steps that are necessary and/or desirable to assist Licensor to obtain such Regulatory Approvals in the name of Licensor (or its designee) in the Territory, with such actions including without limitation coordinating with the applicable Regulatory Authority, furnishing all necessary information and documents in respect thereof, and promptly cancelling and terminating (as necessary) all Regulatory Approvals held by the Licensee, its Affiliate(s), Sublicensee(s) and/or other designee(s) which are not otherwise assignable or transferable to the Licensor (or its designee); Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(iii); and (iv) Licensee shall assign (or cause its Affiliates to assign) to Licensor all agreements with any Third Party with respect to the conduct of clinical trials for the Licensed Product, including agreements with contract research organizations, clinical sites and investigators, unless expressly prohibited by any such agreement or unless such agreement covers clinical trials for products in addition to the Licensed Products (in which case Licensee shall cooperate with Licensor in all reasonable respects to secure the consent of such Third Party to such assignment or to the conclusion of a new agreement between the Licensor and the Third Party on terms substantially similar to the agreement between Licensee and the Third Party), and Licensor shall assume all obligations under all such agreements.

Transfer of Materials. In AGTC shall provide to LICENSEE the event of early termination of this Agreement in accordance with Section 12.2 ( c ) above: (i) Materials to the extent not already transferred pursuant under the Collaboration Agreement. Prior to Section 12.3(a), Licensee shall provide to Licensor a copy the commencement of Manufacturing of any Product by LICENSEE, AGTC shall transfer to LICENSEE, at LICENSEE’s request, any Materials specific to such Product and all documentation reasonable quantities of Materials that are not specific to such Product that are necessary or useful to enable LICENSEE to practice its license and data owned by Licensee rights under this Agreement. LICENSEE shall, subject to the terms and retained rights included in tangible form at the time of termination Existing License Agreements as set forth in Section 4.4, have sole ownership of the Materials delivered to LICENSEE under this Section 4.3, or, if AGTC cannot transfer ownership of such Materials to LICENSEE, AGTC shall, and hereby does, transfer to LICENSEE all of AGTC’s right, title and interest in and to such Materials. All Materials shall be used only in the fulfillment of obligations or exercise of rights under this Agreement that has been generated and solely under the control of LICENSEE, shall not be used or delivered by the LICENSEE to or for the benefit of any Third Party (other than a permitted subcontractor or Sublicensee) without the prior written consent of AGTC, and, except with respect to the Licensed Product and is necessary to enable Licensor to continue development of a Licensed Product and the commercialization thereof in the Territory (collectively, the “Licensee Product Data”), and Licensor may use such Licensee Product Data at its discretion on an exclusive basis, any Materials provided by AGTC to the extent necessary to enable LicensorLICENSEE hereunder for use in a Clinical Trial, its Affiliates and Third Parties on behalf of Licensor or its Affiliates to continue to develop and commercialize a Licensed Product in the Territory; and (ii) if such termination occurs after a Licensed Product has received Regulatory Approval, Licensee shall, if permitted under applicable Law, promptly transfer and deliver to Licensor original copies of any and all Regulatory Approvals obtained in connection with the Licensed Product in the Territory (including any and all official registrations, licenses, permits, certificates, and/or importation documents issued by Regulatory Authorities in the Territory), as well as any and all regulatory documentation and applications for Regulatory Approval submitted to Regulatory Authorities in the Territory in connection with the Licensed Product; Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(ii); and (iii) to the extent that any Regulatory Approval is issued in the name of Licensee, its Affiliates, Sublicensees or other designee, Licensee shall, to the extent permitted by applicable Law, promptly assign or procure the assignment to Licensor (or its designee) such Regulatory Approvals, and in the event assignment is not permitted under applicable Law or cannot be carried out for any other reason, the Licensee shall take all steps that are necessary and/or desirable to assist Licensor to obtain such Regulatory Approvals used in the name of Licensor (research or its designee) in the Territory, with such actions including without limitation coordinating with the applicable Regulatory Authority, furnishing all necessary information and documents in respect thereof, and promptly cancelling and terminating (as necessary) all Regulatory Approvals held by the Licensee, its Affiliate(s), Sublicensee(s) and/or other designee(s) which are not otherwise assignable or transferable to the Licensor (or its designee); Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(iii); and (iv) Licensee shall assign (or cause its Affiliates to assign) to Licensor all agreements with any Third Party with respect to the conduct of clinical trials for the Licensed Product, including agreements with contract research organizations, clinical sites and investigatorstesting involving human subjects, unless expressly prohibited by agreed. All Materials supplied under this Section 4.3 are supplied “as is”, with no warranties of fitness for a particular purpose and must be used with prudence and appropriate caution in any such agreement or unless such agreement covers clinical trials for products in addition to the Licensed Products (in which case Licensee experimental work, since not all of their characteristics may be known. The transfer of Materials under this Section 4.3 shall cooperate with Licensor in all reasonable respects to secure the consent of such Third Party to such assignment or to the conclusion of a new agreement between the Licensor and the Third Party on terms substantially similar to the agreement between Licensee and the Third Party), and Licensor shall assume all obligations under all such agreementsbe conducted at AGTC’s expense.

Transfer of Materials. In 4.1 It is envisaged that from time to time over the event of early termination term of this Agreement that Materials may be transferred from the Site to the Sponsor and/or a third party or third parties named in the Protocol (the “Authorised Third Party”) for the purpose of undertaking the Trial in accordance with Section 12.2 ( c ) above: (i) the Protocol or future research as approved by an appropriate ethics committee. If such Material transfer is applicable to the extent not transferred pursuant to Section 12.3(a)Trial the Parties agree that they shall both abide by the terms of this clause 4. 4.2 The Sponsor shall and, Licensee where applicable, shall provide to Licensor a copy of any procure that the Authorised Third Party shall keep the Materials and all documentation and data owned by Licensee and in tangible form associated documents secure at the time of termination Sponsor’s laboratory or that of the Agreement Authorised Third Party and ensure that has been generated with respect access to the Licensed Product Materials and associated documents is necessary to enable Licensor to continue development of a Licensed Product and the commercialization thereof in the Territory (collectively, the “Licensee Product Data”), and Licensor may use such Licensee Product Data at its discretion on an exclusive basis, restricted to the extent necessary to enable LicensorSponsor and Authorised Third Party, its Affiliates their respective authorised co-workers and Third Parties on behalf of Licensor or its Affiliates to continue to develop and commercialize a Licensed Product in the Territory; and (ii) if such termination occurs after a Licensed Product has received Regulatory Approval, Licensee shall, if permitted under applicable Law, promptly transfer and deliver to Licensor original copies of any and all Regulatory Approvals obtained in connection agents who have entered into legally binding obligations with the Licensed Product in the Territory (including any and all official registrations, licenses, permits, certificates, and/or importation documents issued by Regulatory Authorities in the Territory), as well as any and all regulatory documentation and applications for Regulatory Approval submitted to Regulatory Authorities in the Territory in connection with the Licensed Product; Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(ii); and (iii) to the extent that any Regulatory Approval is issued in the name of Licensee, its Affiliates, Sublicensees Sponsor or other designee, Licensee shall, to the extent permitted by applicable Law, promptly assign or procure the assignment to Licensor (or its designee) such Regulatory Approvals, and in the event assignment is not permitted under applicable Law or cannot be carried out for any other reason, the Licensee shall take all steps that are necessary and/or desirable to assist Licensor to obtain such Regulatory Approvals in the name of Licensor (or its designee) in the Territory, with such actions including without limitation coordinating with the applicable Regulatory Authority, furnishing all necessary information and documents in respect thereof, and promptly cancelling and terminating (as necessary) all Regulatory Approvals held by the Licensee, its Affiliate(s), Sublicensee(s) and/or other designee(s) which are not otherwise assignable or transferable to the Licensor (or its designee); Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(iii); and (iv) Licensee shall assign (or cause its Affiliates to assign) to Licensor all agreements with any Third Party with respect to the conduct of clinical trials for the Licensed Product, including agreements with contract research organizations, clinical sites and investigators, unless expressly prohibited by any such agreement or unless such agreement covers clinical trials for products in addition to the Licensed Products (in which case Licensee shall cooperate with Licensor in all reasonable respects to secure the consent of such Third Party to such assignment or to the conclusion of a new agreement between the Licensor and the Authorised Third Party on terms substantially similar equivalent to those set out in this Agreement concerning the Materials, associated documents, data, Intellectual Property and Confidential Information. 4.3 The Site shall ensure that Materials are (or have been) collected and handled in accordance with the Human Tissue Act 2004, any amendments thereto and any other applicable relevant legislative and regulatory requirements and codes of practice. 4.4 The Sponsor shall and shall procure that the Authorised Third Party shall ensure that the Materials will be stored, accessed and processed in accordance with the Human Tissue Act 2004, any amendments thereto and any other applicable relevant legislative and regulatory requirements and GCP and use any Material or other information provided by or derived from a Trial Subject and/or provided by or on behalf of the Site to the agreement between Licensee Sponsor or Authorised Third Party only as outlined in the Protocol (or associated future ethically approved research) and in accordance with the consent provided by the Trial Subject. 4.5 All documents and information provided with the Materials including patient data shall be considered Confidential Information. 4.6 The Parties acknowledge that the Materials may be fully used up during the Sponsor’s or Authorised Third Party)’s processing of the Materials. 4.7 The Sponsor shall and shall procure that the Authorised Third Party shall ensure that the Materials are traceable at all times while in the possession of the Sponsor or Authorised Third Party. 4.8 The Materials are supplied without cost but the CTC shall pay the costs of shipping that may be incurred as part of the ‘per patient’ payments outlined in Appendix 5. 4.9 Subject to clause 4.10 the Materials are supplied without warranty as to their properties, merchantable quality or fitness for any particular purposes and Licensor without any other warranty whatsoever, expressed or implied. 4.10 In supplying the Materials the Site warrants that the original supply from the Trial Subject complied with all legal and ethical requirements and guidelines and that it has obtained the Trial Subject’s express informed consent to the use of such Materials in accordance with the patient information sheet and consent form for the Trial. 4.11 The Site shall assume provide proof of consent upon request of the Sponsor as evidence of compliance with the provisions of clause 4.10; 4.12 The Sponsor shall and shall procure that the Authorised Third Party shall comply with all obligations under applicable laws and any relevant guidance issued by the Department of Health or equivalent authority and all such agreementsethical guidelines relating to the use, storage, transportation and disposal of Materials (including where relevant, human tissue) for research purposes laid down by the competent body or authority.

Transfer of Materials. In During the event Research Term, each Party (the “Transferor”) agrees to transfer sufficient quantities any biopharmaceutical, biological or chemical material (the “Transferred Material”) to the other Party (the “Transferee”) to conduct its activities under the Research Programs as set forth in the Research Plan or as otherwise determined by the JRC, such transfer shall take place in accordance with the following provisions: (a) Transferred Materials and related information provided by the Transferor shall, as between the Parties, remain the property of early termination the Transferor, shall be the Confidential Information of the Transferor, shall be kept securely by the Transferee and shall not be provided by the Transferee to any Third Party without the prior written consent of the Transferor. (b) The Transferee shall only use the Transferred Material for the purpose of performing the applicable activities as laid out under the Research Plan or otherwise pursuant to this Agreement and use the Transferred Materials in accordance with all Applicable Laws. (c) The Transferee shall not, save as necessary for the conduct of work as laid out under the Research Plan, use the Transferred Material in any human or animal subjects. (d) The Transferee shall not provide any of the Transferred Material to any Third Party other than to subcontractors appointed in accordance with Section 12.2 ( c ) above:3.8 and subject always to the provisions of Section 3.8, and the Transferee shall ensure that such subcontractors appointed in accordance with Section 3.8 comply with the same restrictions as set forth in this Section 3.11. (ie) to The Transferee acknowledges that the extent not transferred pursuant to Section 12.3(a), Licensee shall provide to Licensor a copy Transferred Material is experimental in nature and provided “as is” and that the Transferor makes no representation or extends no warranty of any and all documentation and data owned by Licensee and in tangible form at the time of termination of the Agreement that has been generated kind with respect to the Licensed Product Transferred Material and is necessary to enable Licensor to continue development hereby disclaims all warranties, either express or implied, including, but not limited to, any warranty of merchantability, fitness for a Licensed Product and particular purpose or that their use does not or shall not infringe any patent rights of third parties. (f) The Transferee shall use the commercialization thereof in the Territory (collectively, the “Licensee Product Data”), and Licensor may use such Licensee Product Data Transferred Material at its discretion on an exclusive basis, to own risk and in accordance with Applicable Laws and any safety instructions provided by the extent necessary to enable Licensor, its Affiliates and Third Parties on behalf of Licensor or its Affiliates to continue to develop and commercialize a Licensed Product in the Territory; andTransferor. (iig) if such termination occurs after a Licensed Product has received Regulatory Approval, Licensee The Transferee shall, if permitted under applicable Lawat the election of the Transferor following completion of the purpose for which the Transferred Material was transferred, promptly transfer and deliver to Licensor original copies of any and all Regulatory Approvals obtained in connection with destroy or return the Licensed Product in the Territory (including any and all official registrations, licenses, permits, certificates, and/or importation documents issued by Regulatory Authorities in the Territory), as well as any and all regulatory documentation and applications for Regulatory Approval submitted to Regulatory Authorities in the Territory in connection with the Licensed Product; Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(ii); and (iii) to the extent that any Regulatory Approval is issued in the name of Licensee, its Affiliates, Sublicensees or other designee, Licensee shall, to the extent permitted by applicable Law, promptly assign or procure the assignment to Licensor (or its designee) such Regulatory Approvals, and in the event assignment is not permitted under applicable Law or cannot be carried out for any other reason, the Licensee shall take all steps that are necessary and/or desirable to assist Licensor to obtain such Regulatory Approvals in the name of Licensor (or its designee) in the Territory, with such actions including without limitation coordinating with the applicable Regulatory Authority, furnishing all necessary information and documents in respect thereof, and promptly cancelling and terminating (as necessary) all Regulatory Approvals held by the Licensee, its Affiliate(s), Sublicensee(s) and/or other designee(s) which are not otherwise assignable or transferable to the Licensor (or its designee); Licensor shall pay Licensee’s direct, out-of-pocket costs for compliance with this Section 12.3(b)(iii); and (iv) Licensee shall assign (or cause its Affiliates to assign) to Licensor all agreements with any Third Party with respect to the conduct of clinical trials for the Licensed Product, including agreements with contract research organizations, clinical sites and investigators, unless expressly prohibited by any such agreement or unless such agreement covers clinical trials for products in addition to the Licensed Products (in which case Licensee shall cooperate with Licensor in all reasonable respects to secure the consent of such Third Party to such assignment or to the conclusion of a new agreement between the Licensor and the Third Party on terms substantially similar to the agreement between Licensee and the Third Party), and Licensor shall assume all obligations under all such agreementsTransferred Material.