Licensor Technology Transfer. After the Effective Date and before Licensee commences Manufacturing of the Licensed Compounds and Licensed Products on its own behalf, Licensee shall have the right to require Licensor to effect a full transfer to Licensee or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Licensee Know-How relating to the then-current process for the Manufacture of Licensed Products and Licensed Compounds (the “ Manufacturing Process ”) and to implement the Manufacturing Process at facilities designated by Licensee (such transfer and implementation, as more fully described in this Section 4.10, the “ Technology Transfer ”). Licensor shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following Effective Date), all reasonable assistance requested by Licensee to enable Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to implement the Manufacturing Process at the facilities designated by Licensee. If requested by Licensee, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to the Licensed Products and Licensed Compounds. Without limitation to the foregoing, in connection with each Technology Transfer: (i) After the Effective Date and before Licensee commences Manufacturing of the Licensed Compounds and Licensed Products on its own behalf, at Licensee’s reasonable request, Licensor shall make available, and shall use commercially reasonable efforts to cause its Third Party manufacturers to make available (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), to Licensee (or its Affiliate or designated Third Party manufacturer, as applicable), all of Licensor’s Manufacturing Know-How, Information and materials relating to the Manufacturing Process, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to materials to be used and control methods, that are reasonably necessary or useful to enable Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process; (ii) At Licensee’s reasonable request, Licensor shall cause all appropriate employees and representatives of Licensor and its Affiliates to meet with, and shall use commercially reasonable efforts to cause all appropriate employees and representatives of its Third Party manufacturers to meet with (including using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. entered into following the Effective Date), employees or representatives of Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of the Manufacturing Process and with the training of the personnel of Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to the extent reasonably necessary or useful to enable Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process; (iii) Without limiting the generality of clause (ii) above, at Licensee’s reasonable request, Licensor shall cause all appropriate analytical and quality control laboratory employees and representatives of Licensor and its Affiliates to meet with, and shall use commercially reasonable efforts to cause all appropriate analytical and quality control laboratory employees and representative of its Third Party manufacturers to meet with (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), employees or representatives of Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the transfer of all applicable analytical methods and the validation thereof (including, all applicable Know-How, methods, validation documents and other documentation, materials and sufficient supplies of all primary and other reference standards); (iv) At Licensee’s reasonable request, Licensor shall take such steps, and shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), as are reasonably necessary or useful to assist in reasonable respects Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the Licensed Products and Licensed Compounds at the applicable facilities; and (v) At Licensee’s reasonable request, Licensor shall provide and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), such other assistance as Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process and otherwise to Manufacture the Licensed Products and Licensed Compounds. Licensee shall pay to Licensor: (a) its reasonable, out-of-pocket costs and (b) to the extent of any of Licensor’s personnel travel outside Dallas, Texas to perform obligations under this Section 4.10, the FTE Costs incurred by Licensor in connection therewith (solely to the extent such FTE costs exceed One Hundred Forty Thousand Dollars ($140,000) during the Term), in each case of (a) and (b) incurred directly as a result of performing each Technology Transfer. Licensee shall make such payment within [***] days following Licensor providing Licensee with an invoice and reasonable supporting documentation (including receipts) therefor. Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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Licensor Technology Transfer. After the Effective Date and before Licensee commences Manufacturing of the Licensed Compounds and Licensed Products on its own behalf, Licensee shall have the right to require Licensor to effect a full transfer to Licensee or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Licensee Know-How relating to the then-current process for the Manufacture of Licensed Products and Licensed Compounds (the “ “Manufacturing Process Process”) and to implement the Manufacturing Process at facilities designated by Licensee (such transfer and implementation, as more fully described in this Section 4.10, the “ “Technology Transfer Transfer”). Licensor shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following Effective Date), all reasonable assistance requested by Licensee to enable Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to implement the Manufacturing Process at the facilities designated by Licensee. If requested by Licensee, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to the Licensed Products and Licensed Compounds. Without limitation to the foregoing, in connection with each Technology Transfer:
(i) After the Effective Date and before Licensee commences Manufacturing of the Licensed Compounds and Licensed Products on its own behalf, at Licensee’s reasonable request, Licensor shall make available, and shall use commercially reasonable efforts to cause its Third Party manufacturers to make available (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), to Licensee (or its Affiliate or designated Third Party manufacturer, as applicable), all of Licensor’s Manufacturing Know-How, Information and materials relating to the Manufacturing Process, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to materials to be used and control methods, that are reasonably necessary or useful to enable Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process;
(ii) At Licensee’s reasonable request, Licensor shall cause all appropriate employees and representatives of Licensor and its Affiliates to meet with, and shall use commercially reasonable efforts to cause all appropriate employees and representatives of its Third Party manufacturers to meet with (including using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. entered into following the Effective Date), employees or representatives of Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of the Manufacturing Process and with the training of the personnel of Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to the extent reasonably necessary or useful to enable Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process;
(iii) Without limiting the generality of clause (ii) above, at Licensee’s reasonable request, Licensor shall cause all appropriate analytical and quality control laboratory employees and representatives of Licensor and its Affiliates to meet with, and shall use commercially reasonable efforts to cause all appropriate analytical and quality control laboratory employees and representative of its Third Party manufacturers to meet with (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), employees or representatives of Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the transfer of all applicable analytical methods and the validation thereof (including, all applicable Know-How, methods, validation documents and other documentation, materials and sufficient supplies of all primary and other reference standards);
(iv) At Licensee’s reasonable request, Licensor shall take such steps, and shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), as are reasonably necessary or useful to assist in reasonable respects Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the Licensed Products and Licensed Compounds at the applicable facilities; and
(v) At Licensee’s reasonable request, Licensor shall provide and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), such other assistance as Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable Licensee (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice the Manufacturing Process and otherwise to Manufacture the Licensed Products and Licensed Compounds. Licensee shall pay to Licensor: (a) its reasonable, out-of-pocket costs [***] and (b) to the extent of any of Licensor’s personnel travel outside Dallas, Texas to perform obligations under this Section 4.10, the FTE Costs [***] incurred by Licensor in connection therewith (solely to the extent such FTE costs [***] exceed One Hundred Forty Thousand [***] Dollars ($140,000) during the Term), in each case of (a) and (b) incurred directly as a result of performing each Technology Transfer. Licensee shall make such payment within [***] days following Licensor providing Licensee with an invoice and reasonable supporting documentation (including receipts) therefor. Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
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