Common use of Program Materials Clause in Contracts

Program Materials. (a) Customer will provide Laureate with sufficient amounts of Cell Line reference standards or other Materials with which to perform the Program, as well as all documentation and such other data owned or controlled by Customer as Laureate reasonably determines may be necessary to apprise Laureate of the stability of the Materials, process characteristics, proper storage, and manufacturing and safety requirements, including without limitation, the Certificate of Analysis relating to the Cell Line and reference standards as specified in Appendix 4 attached hereto. Any Product-Dedicated Equipment provided to Laureate by Customer shall be in good operating condition and free from all material defects. (b) Laureate shall procure the Materials, Filling Components and Process Consumables for use in the Program and each manufacturing run. By written notice to Laureate, Customer may procure certain Materials specified in the Scope, such as media and resins. (c) Laureate shall procure the Product-Dedicated Equipment and pass through the costs to the Customer consistent with Section 8. Prior to any such procurement of Product-Dedicated Equipment, Laureate shall notify Customer in writing of the specific Product-Dedicated Equipment required and the expected cost of such Product-Dedicated Equipment. By written notice to Laureate, Customer may procure certain Product-Dedicated Equipment for use in the Program at its own expense. (d) Upon completion of the Program (i) the Product-Dedicated Equipment paid for by Customer in accordance with Section 4(c) and Section 8 will be returned to the Customer, at the Customer's expense and (ii) any remaining samples of the Materials, documentation or data provided to Laureate will be returned to the Customer or, upon written authorization from Customer, destroyed/disposed of by Laureate. Samples of such Materials and copies of such documentation or data may be retained by Laureate to the extent required by applicable regulatory requirements. (e) Prior to each use of the Equipment in manufacturing the Bulk Intermediate, Laureate agrees to implement a cleaning validation protocol with respect to the Equipment in compliance with Good Manufacturing Practices. (f) Except with the prior written consent of Customer, Laureate shall use the Product-Dedicated Equipment only to manufacture Bulk Intermediate, Process Components and other products pursuant to this Agreement (collectively, "Customer Products"). In requesting Customer's consent to use Product-Dedicated Equipment for the manufacture of non-Customer Products, Laureate shall provide Customer with complete information regarding such non-Customer Products and the cleaning and maintenance of such machinery or equipment, in order to allow Customer to evaluate the risk of cross-contamination. (g) Laureate shall maintain in the Facility adequate and segregated holding accommodations for the Bulk Intermediate, Process Components and other items used in manufacturing the Bulk Intermediate, and shall hold the Bulk Intermediate in a separate segregated area until delivery to Customer.

Program Materials. (a) Customer will provide Laureate with sufficient amounts of Cell Line Line, reference standards standards, or other Materials substances with which to perform the ProgramProgram as specified in the Scope, as well as all documentation and such other data owned or controlled by Customer as Laureate reasonably determines may be necessary to apprise Laureate of the stability of the Materials, process characteristics, proper storage, and manufacturing and safety requirements, including including, without limitation, the Certificate a certificate of Analysis analysis relating to the Cell Line and reference standards as specified in Appendix 4 attached hereto4. Any Product-Dedicated Equipment provided to Laureate by Customer shall be in good operating condition and free from all material defects. Laureate will maintain within its sole possession and control any Cell Line and biological material derived therefrom (for example, nucleic acids such as expression vectors, genes encoding the Drug Substance, etc.), as well as any cell line derived therefrom by Laureate for production of Drug Substance pursuant to the Program. Notwithstanding anything to the contrary herein, except for the purpose of carrying out the activities specified in the Scope, Laureate will not for its own account or for the benefit of a Third Party propagate, culture, express, produce, distribute, dispose of, transfer, or sell any Cell Line or Material for any purpose whatsoever without the prior written consent of Customer. (b) Laureate shall procure the Materials, Filling Components Components, and Process Consumables for use in the Program and each manufacturing run. By written notice to Laureate, Customer may procure certain Materials Filling Components specified in the Scope, such as media and media, resins, vials, overseals, or stoppers. (c) Laureate shall identify to Customer such Product-Dedicated Equipment as may be required, including recommended vendors, quantities, and such other information as needed by Customer in order to procure Product-Dedicated Equipment required by Laureate to perform the Program. Upon Customer’s authorization, Laureate may procure the Product-Dedicated Equipment and pass through the costs to the Customer consistent with Section 8. Prior to any such procurement of Product-Dedicated Equipment7, Laureate shall notify provided that Customer has approved in writing of the specific Product-Dedicated Equipment required and the expected cost of such Product-Dedicated Equipmentin advance Laureate’s purchase thereof. By written notice to Laureate, Customer may procure certain Product-Dedicated Equipment for use in the Program at its own expense. (d) Upon completion of the Program Program, (i) the Product-Dedicated Equipment paid for by Customer in accordance with Section 4(c) and Section 8 will be returned to the Customer, at the Customer's expense ’s expense, and (ii) any remaining samples of the MaterialsMaterials or other substances, documentation documentation, or data provided to Laureate will be returned to the Customer or, upon written authorization from Customer, or retained by Laureate in compliance with applicable regulatory requirements or destroyed/disposed of by Laureate. Samples of such Materials and copies of such documentation or data may be retained by Laureate to the extent required by applicable regulatory requirements. (e) Prior to each use of the Equipment in manufacturing the Bulk Intermediate, Laureate agrees to implement a cleaning validation protocol with respect to the Equipment in compliance with Good Manufacturing Practices. (f) Except with the prior under written consent of Customer, Laureate shall use the Product-Dedicated Equipment only to manufacture Bulk Intermediate, Process Components and other products pursuant to this Agreement (collectively, "Customer Products"). In requesting Customer's consent to use Product-Dedicated Equipment for the manufacture of non-Customer Products, Laureate shall provide Customer with complete information regarding such non-Customer Products and the cleaning and maintenance of such machinery or equipment, in order to allow Customer to evaluate the risk of cross-contamination. (g) Laureate shall maintain in the Facility adequate and segregated holding accommodations for the Bulk Intermediate, Process Components and other items used in manufacturing the Bulk Intermediate, and shall hold the Bulk Intermediate in a separate segregated area until delivery to authorization from Customer.

Program Materials. (a) Laureate acknowledges that the Cell Line has been provided to Laureate by Medarex under the Medarex MTA. Customer will provide is responsible for providing Laureate with sufficient amounts of Cell Line as reasonably requested by Laureate. Under any Scope, Customer is responsible for providing Laureate with reference standards or and other Materials substances, with which to perform the ProgramProgram as specified in a particular Scope, as well as all documentation and such other data owned or controlled by Customer as Laureate reasonably determines may be necessary for Laureate to perform the Program as specified in a particular Scope and to apprise Laureate of the stability of the Compound and Compound Materials, process characteristics, proper storage, and manufacturing and safety requirementsrequirements including, including without limitation, the Certificate of Analysis and/or Material Safety Data Sheet, as applicable, relating to the Cell Line and reference standards as specified in Appendix 4 attached hereto. Any Product-Dedicated Equipment provided to Laureate by Customer shall be in good operating condition and free from all material defectsa relevant Scope. (b) Laureate shall procure the MaterialsCompound, Filling Components Components, cell culture media, and Process Consumables for use in the Program and each manufacturing runrun all of which will comply with the Specifications. By written notice to Laureate, Customer may procure certain Materials Filling Components specified in the a Scope, such as media, resins, vials, overseals or stoppers. By written notice to Laureate from Customer, Laureate will procure and store, at Customer's sole cost and expense, materials, Filling Components, cell culture media, and Process Consumables in sufficient quantities to serve as "safety stock" for the completion of one 2000L production run. For clarity, the Parties acknowledge and agree that some materials described in this Section 4(b) may be obtained by Laureate from Medarex's supplier of media pursuant to written authorizations from Medarex to Laureate and resinsfrom Medarex to its supplier of media, authorizing direct procurement by Laureate from Medarex's media supplier of media relating to the Program; copies of such authorizations attached hereto as Schedule 4(b). (c) Laureate shall procure the any Product-Dedicated Equipment and pass through the costs to the Customer consistent with Section 8. Prior For any Scope, Laureate will obtain the written consent of Customer prior to procuring any such procurement single piece of Product-Dedicated EquipmentEquipment that costs $[***] or more, Laureate shall notify Customer in writing or multiple pieces of the specific Product-Dedicated Equipment required and that cost more than [***], in the expected cost of such Product-Dedicated Equipmentaggregate. By written notice to Laureate, Customer may procure and provide certain Product-Dedicated Equipment for use in the Program at its own expense. If Customer provides any Product-Dedicated Equipment to Laureate, such equipment shall be in good operating condition and free from all material defects and Contaminants. All right, title and interest in any Product-Dedicated Equipment ---------- *** Portions of this page have been omitted pursuant to a Request for Confidential Treatment filed separately with the SEC. shall be vested in Customer. Customer may file financing statements or other similar documentation in order to serve as notice or otherwise perfect its interest in any Product-Dedicated Equipment. (d) Upon completion of the Program Program, (i) the Product-Dedicated Equipment paid for by Customer in accordance with Section 4(c) and Section 8 will be returned to the Customer, at the Customer's expense and (ii) any remaining samples of the MaterialsCompound or other substances, documentation or data provided to Laureate will be returned returned, at the Customer's request, to the Customer or, upon written authorization from Customer, or retained by Laureate in compliance with applicable regulatory requirements or destroyed/disposed of by Laureate. Samples of such Materials and copies of such documentation or data may be retained by Laureate to the extent required by applicable regulatory requirements. (e) Prior to each use of the Equipment in manufacturing the Bulk Intermediate, Laureate agrees to implement a cleaning validation protocol with respect to the Equipment in compliance with Good Manufacturing Practices. (f) Except with the prior under written consent of Customer, Laureate shall use the Product-Dedicated Equipment only to manufacture Bulk Intermediate, Process Components and other products pursuant to this Agreement (collectively, "Customer Products"). In requesting Customer's consent to use Product-Dedicated Equipment for the manufacture of non-Customer Products, Laureate shall provide Customer with complete information regarding such non-Customer Products and the cleaning and maintenance of such machinery or equipment, in order to allow Customer to evaluate the risk of cross-contamination. (g) Laureate shall maintain in the Facility adequate and segregated holding accommodations for the Bulk Intermediate, Process Components and other items used in manufacturing the Bulk Intermediate, and shall hold the Bulk Intermediate in a separate segregated area until delivery to authorization from Customer.