Client Deliverables. Within the time period specified in a Statement of Work, CLIENT shall provide LONZA with (a) the materials that are not commercially available in the U.S. and CLIENT is responsible for delivering to LONZA under the relevant Statement of Work, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for LONZA’s performance under the Statement of Work, and (b) any other protocols, SOPs and other information and documentation in possession or control of CLIENT and necessary for LONZA’s performance of the Statement of Work, and for LONZA’s preparation of the Project Documentation in conformance with cGMP, including, without limitation, process information, SOPs, development data and reports, quality control assays, raw material specifications (including vendor, grade and sampling/testing requirements), product and sample packaging and shipping instructions, and product specific cleaning and decontamination information, (collectively, the “CLIENT Development Materials”). For the avoidance of doubt, LONZA shall procure other materials, protocols, SOPs, information and documentation required for the performance of the relevant Statement of Work, except for CLIENT Development Materials. If CLIENT does not provide the CLIENT Development Materials within the time period specified in the relevant Statement of Work, then CLIENT shall be responsible for any actual and reasonable costs incurred by LONZA arising from such failure, provided that LONZA shall use commercially reasonable efforts to minimize such costs. It is hereby agreed that CLIENT Development Materials, to the extent such are maintained as Confidential Information or proprietary information by CLIENT, are the proprietary and Confidential Information of CLIENT and shall be used by LONZA only for the purpose of performing LONZA’s obligations under this Agreement and the relevant Statement of Work.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Gracell Biotechnologies Inc.)
Client Deliverables. Within the time period specified in a Statement of Work, CLIENT shall will provide LONZA with (a) the materials that are not commercially available listed in the U.S. and Statement of Work for which CLIENT is responsible for delivering to LONZA under the relevant Statement of WorkLONZA, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for LONZA’s the performance under of the Statement of Work, and (b) any other protocols, SOPs and other information and documentation in possession or control of CLIENT and necessary for LONZA’s the performance of the Statement of Work, and for LONZA’s the preparation of the Project Documentation in conformance with cGMP, including, without limitation, including manufacturing process information, SOPs, development data and reports, quality control assays, raw material specifications (including vendor, grade and sampling/testing requirements), product and sample packaging packing and shipping instructions, and product specific cleaning and decontamination information, (collectivelycollectively the materials in clauses (a) and (b), the “CLIENT Development Materials”). For the avoidance of doubt, LONZA shall procure other materials, protocols, SOPs, information and documentation required for the performance of the relevant Statement of Work, except for CLIENT Development Materials. If CLIENT does not provide the CLIENT Development Materials within the time period specified in the relevant a Statement of Work, then CLIENT LONZA shall be responsible excused for any actual and reasonable costs incurred by LONZA delays in performing the applicable Statement of Work arising from such failure, provided that . LONZA shall have the right to use commercially reasonable efforts to minimize such costs. It is hereby agreed that the CLIENT Development Materials, to the extent such are maintained as Confidential Information or proprietary information by CLIENT, are the proprietary and Confidential Information of CLIENT and shall be used by LONZA only Materials solely for the purpose of performing LONZAServices. LONZA and its Affiliates will not use the CLIENT Materials (or any part thereof) for any other purpose without CLIENT’s prior written consent. CLIENT shall retain all right, title and interest in and to CLIENT Materials. LONZA shall: (i) at all times use all reasonable endeavours to keep CLIENT Materials secure and safe from loss, damage, theft, misuse and unauthorized access in such manner as LONZA stores its own materials of similar nature; (ii) use the CLIENT Materials in compliance with Applicable Law and comply with any safety precautions and instructions accompanying the CLIENT Materials; (iii) not use the CLIENT Materials for the benefit of any Third Party, transfer the CLIENT Materials to any Third Party or otherwise part with possession of the CLIENT Materials or the Product, save for the purpose of tests at any Third Party instructed by LONZA and approved by CLIENT to carry out tests on the CLIENT Materials or the Product (such Third Parties, “Testing Laboratories”) or as directed by CLIENT; (iv) not attempt to reverse-engineer or otherwise determine the genetic or amino acid sequence of the CLIENT Materials without the prior written consent of CLIENT; and (v) cause all Testing Laboratories to be subject to confidentiality and non-use obligations no less onerous than those confidentiality and non-use obligations imposed on LONZA under this Agreement and the relevant Statement of WorkAgreement.
Appears in 1 contract
Client Deliverables. 2.3.1 Within the time period specified in a Statement of Work, CLIENT shall will provide LONZA LWI with (a) the materials that are not commercially available listed in the U.S. and Statement of Work for which CLIENT is responsible for delivering to LONZA under the relevant Statement of WorkLWI, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for LONZA’s the performance under of the Statement of Work, and (b) any other related protocols, SOPs and other information and documentation in possession or control of CLIENT and necessary for LONZA’s the performance of the Statement of Work, and for LONZA’s the preparation of the Project Documentation Master Production Record in conformance with cGMP, including, without limitation, process information, SOPs, development data and reports, quality control assays, raw material specifications (including vendor, grade and sampling/testing requirements), product and sample packaging packing and shipping instructions, and product specific cleaning and decontamination information, information (collectively, the “CLIENT Development Materials”). For clarity, CLIENT Development Materials includes CLIENT’s PANC 10.3 and PANC 6.05 cell lines (the avoidance of doubt, LONZA “Cell Lines”).
2.3.2 LWI agrees that the CLIENT Development Materials shall procure other materials, protocols, SOPs, information and documentation required for only be used as specified in writing by CLIENT in this Agreement or the performance of the relevant applicable Statement of Work, except and not for any other purpose. CLIENT Development Materials shall be maintained, handled and stored in accordance with the written directions of CLIENT. Title to the CLIENT Development Materials shall at all times remain in CLIENT. LWI agrees that it shall not make any claim or place any lien or encumbrance on any CLIENT Development Materials. If Upon direction of CLIENT, LWI shall provide CLIENT does not provide with an accounting of the CLIENT Development Materials within and a list of persons with access to the time period specified CLIENT Development Materials, and will return to CLIENT all CLIENT Development Materials supplied by CLIENT, except to the extent such CLIENT Development Materials are no longer available to return as the materials have been utilized, or are incorporated in Product or work in process in connection with the services performed hereunder. Risk of loss to Cell Lines shall remain with LWI while CLIENT Developed Materials are in LWI’s control, except for any risk of loss that is inherent to the Cell Lines and so long as the loss is unrelated to the negligent or willful acts or omissions of LWI or its agents. CLIENT shall have the absolute right upon reasonable notice and reasonable request to recover the CLIENT Development Materials, except to the extent such CLIENT Development Materials are no longer available to return as the materials have been utilized or are incorporated in Product or work in process in connection with the services performed hereunder, and LWI shall cooperate in the same. Title to each cell line made from Cell Lines shall vest in CLIENT after CLIENT pays LWI for the cost for the creation of each such cell line, as such cost is specifically set forth in the relevant Statement of Work, then CLIENT shall be responsible for .
2.3.3 LWI covenants not to share any actual and reasonable costs incurred by LONZA arising from such failure, provided that LONZA shall use commercially reasonable efforts to minimize such costs. It is hereby agreed that CLIENT Development MaterialsMaterials with any person located outside the United States without the express prior written consent of CLIENT, which consent shall not be unreasonably withheld or delayed if (i) LWI demonstrates to CLIENT that such sharing is essential to the extent such are maintained as Confidential Information or proprietary information by CLIENT, are the proprietary and Confidential Information purposes of CLIENT and shall be used by LONZA only for the purpose of performing LONZA’s obligations under this Agreement and no reasonable alternative is available and (ii) the relevant Statement of Workreceiving party, LWI, and CLIENT have executed appropriate written agreements that secure and protect the CLIENT Development Materials and in which LWI takes responsibility for the same.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Aduro Biotech, Inc.)
Client Deliverables. Within the time period specified set forth in Exhibit 5.3, for each Batch ordered by CLIENT pursuant to a Statement of WorkPurchase Order and accepted by LONZA, CLIENT shall will provide LONZA with (a) the materials that are not commercially available required to be supplied by CLIENT for the manufacture of such Batch, as set forth in the U.S. and CLIENT is responsible for delivering to LONZA under the relevant Statement of Work, Exhibit 5.3 and any handling instructions, protocols, SOPs and other documentation (collectively, the “CLIENT Production Materials”) necessary to maintain the properties of such materials for LONZA’s performance under the Statement of Work, and (b) any other protocols, SOPs and other information and documentation in possession or control of CLIENT and necessary for LONZA’s performance of the Statement of Work, and for LONZA’s preparation of the Project Documentation in conformance with cGMP, including, without limitation, process information, SOPs, development data and reports, quality control assays, raw material specifications (including vendor, grade and sampling/testing requirements), product and sample packaging and shipping instructions, and product specific cleaning and decontamination information, (collectively, the “CLIENT Development Materials”). For the avoidance of doubt, LONZA shall procure other materials, protocols, SOPs, information and documentation required for the performance of the relevant Statement manufacturing of Work, except for CLIENT Development Materialssuch Batch. If CLIENT does LONZA will not provide the CLIENT Development Materials within the time period specified in the relevant Statement of Work, then CLIENT shall be responsible for any actual and reasonable costs incurred by LONZA arising from such failure, provided that LONZA shall use commercially reasonable efforts to minimize such costs. It is hereby agreed that CLIENT Development Materials, delays in manufacturing or supplying Product to the extent due to CLIENT’s failure to deliver the CLIENT Production Materials within the applicable time period set forth in Exhibit 5.3. In addition, CLIENT shall pay LONZA [***] for the period of such are maintained as Confidential Information or proprietary information by delay that is attributable to CLIENT’s failure. All CLIENT Production Materials shall remain the property of CLIENT, are and the proprietary transfer of physical possession of any such CLIENT Production Materials to, and Confidential Information the physical possession of CLIENT and Production Materials by, LONZA or its Affiliates or Third Party contractors shall not be (nor shall be construed as) a sale, lease, offer to sell or lease, or other transfer of title of such CLIENT Production Materials therein to LONZA, its Affiliates, or Third Party contractors; provided, however, that for any CLIENT Production Materials which have been designated for use in the manufacture of Product in an upcoming Campaign, such CLIENT Production Material shall not be requested to be returned to CLIENT. All CLIENT Production Materials shall be used by LONZA only for and maintained at the purpose of performing LONZA’s obligations Facility or other site at which the applicable activities under this Agreement are performed. LONZA, its Affiliates and Third Party contractors shall only use the relevant Statement CLIENT Production Materials in compliance with all Applicable Laws and solely for the purposes set forth in this Agreement, and shall keep a record of WorkCLIENT Production Materials received and used, discarded or otherwise consumed under and during the course of manufacture and supply under this Agreement.
Appears in 1 contract