Use and Potential Expansion of UTMDACC’s Cell Processing Facility. (1) During the TERM, at LICENSEE’s request and cost, UTMDACC agrees to produce, at its cell processing facility (currently on the [***] of the [***]) and/or at the cell processing facility funded by ZIOPHARM, any human cellular and tissue based STUDY PRODUCT and/or components used to manufacture the STUDY PRODUCT (“HCT STUDY PRODUCT”) for any CLINICAL TRIALS under the oversight of the JSC; provided, however, that UTMDACC will only be [***] to manufacture HCT STUDY PRODUCTS for which it determines in its reasonable discretion that it has the existing ability, capacity, facilities, equipment, resources, and expertise to do so, giving [***] (at a minimum no less than any [***] of [***]) to the use of its resources for the manufacturing of HCT STUDY PRODUCT for use in the RESEARCH PROGRAM in such determination. If UTMDACC is unable to manufacture a product for ongoing or planned clinical trial it will promptly provide written notification to LICENSEE of such inability, together with an explanation for the reason thereof. In the event there are manufacturing activities ongoing pursuant to this Section 3.4 at the end of the TERM, UTMDACC agrees to, at its election: (a) negotiate with LICENSEE the terms and conditions under which UTMDACC will continue to conduct such manufacturing activities on behalf of LICENSEE; or: (b) cooperate with LICENSEE to, at LICENSEE’s cost and expense, effect an orderly transition of such manufacturing activities to LICENSEE or its designee.
(2) The terms for production of any HCT STUDY PRODUCT produced by UTMDACC, including pricing, manufacturing and release specifications, and quality control and quality assurance testing, will be agreed upon by the parties in writing prior to the commencement of manufacturing. All costs and expenses incurred by UTMDACC in connection with the production of such HCT STUDY PRODUCT as agreed to by the parties shall be included in the DEVELOPMENT COSTS and funded by ZIOPHARM in accordance with Section 5, provided that such costs and expenses shall be at a rate that is no greater than that used for any internal programs of UTMDACC.
(3) UTMDACC agrees to maintain all required GMP documentation concerning the production services with respect to the HCT STUDY PRODUCT manufactured by UTMDACC, including documentation of all production and quality control testing, standard operating procedures, training records, batch records, logs and such other matters as may be required by APPLICABLE LAWS or by the specific...
