Master Production Record. Should CBSW need to create additional Master Production Records as the result of commencement of Phase II or the production of Product in the Custom Production Suite, CBSW will prepare such additional Master Production Records under the terms and conditions set forth in Section 5.
Master Production Record. 3.2.1 Based on the information provided by CLIENT and including any process changes developed by LONZA pursuant to any applicable Statement of Work with respect to a Product, LONZA will prepare a Master Production Record for the Process of such Product in accordance with the schedule set forth in the applicable Statement of Work. CLIENT will inform LONZA of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. LONZA shall not include in the Process or Master Production Record the use of any assay, medium, or other technology that is not commercially available or is covered in whole or in part by Intellectual Property of a Third Party without the express written consent of CLIENT pursuant to Section 13.2.2(c)(ii) below.
3.2.2 CLIENT will cooperate to provide to LONZA information that may be available to CLIENT (and that CLIENT has the right and authority to provide) to assist LONZA to develop the Master Production Record and Process with respect to a Product, including, without limitation, by providing LONZA with any such additional information and procedures as may be reasonably required to create such Master Production Record and Process, including any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, and (v) Product specific cleaning and decontamination information. This Section 3.2.2 shall not be construed to require CLIENT to provide information not already in the possession and control of CLIENT, or to provide any information to LONZA in breach of any obligation of CLIENT to any Third Party.
3.2.3 LONZA will deliver a draft version of the Master Production Record for a Product to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LONZA in writing of any objections it has to such draft Master Production Record, and upon such notification, representatives of LONZA and CLIENT will meet promptly to resolve such objections. If CLIENT approves the draft Master Production Record, CLIENT shall notify LONZA in writing of CLIENT’s acceptance, and such draft shall be deemed approved upon such notice from CLIENT. LONZA shall not be liable for any d...
Master Production Record. 2.5.1 Based on the Process developed by CBSW and Clients pursuant to the Development Plan, CBSW will prepare the Master Production Record for the Process. Clients will inform CBSW of any specific requirements Clients may have relating to the Master Production Record, including, without limitation, any information or procedures Clients wish to have incorporated therein. If CBSW intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, CBSW will inform Clients of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process.
2.5.2 Clients will cooperate with CBSW to assist CBSW to develop the Master Production Record and Process, including, without limitation, by providing CBSW with additional information and procedures as may be required to create the Master Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information, (vi) Product Specifications.
2.5.3 CBSW will deliver a draft version of the Master Production Record to Clients for review and approval, within the time period specified in the Development Plan. Clients will notify CBSW in writing of any objections to the Master Production Record, and upon such notification, representatives of CBSW and Clients will meet promptly to resolve such objections.
2.5.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any CBSW Operating Documents or CBSW Confidential Information included in any of the foregoing, will be deemed Confidential Information of Clients and subject to the provisions set forth in Section 9. Each of the Clients has the right to use (itself or through a Third Party) the Process and/or the Master Production Record, conditioned on the following: such Client and any such Third Party must agree in writing to protect CBSW Confidential Information contained therein and such Client’s and/or any such Third Party’s use shall be limited to uses related to Product.
Master Production Record. Subject to the terms and conditions of this Agreement, CBL agrees to process the Product in accordance with a Master Production and Control Record approved in writing by TKT. CBL further agrees that any substantive changes to the Master Production and Control Record and the process must receive written approval of TKT prior to implementation, provided, however, that any approvals to be delivered by TKT shall not be unreasonably withheld and the parties shall cooperate and act reasonably and in good faith in connection with their respective activities under this Section. CBL will permit TKT to review all information in Master Production Records pertaining to individual product lots as well as, raw material test results and the results of environmental monitoring prior to product release by CBL but after CBL’s completion of its internal review of the batch record. CBL will release the batch record within [**] of receiving TKT’s comments and proposed changes.
Master Production Record a set of specific and detailed instructions required to manufacture a batch of intermediates or API.
Master Production Record. 2.7.1. Based on the information provided by CLIENT and including process changes developed by LONZA pursuant to any applicable Statement of Work, LONZA will prepare the Master Production Record for the Process in accordance with the schedule set forth in the Statement of Work. CLIENT will inform LONZA of any specific requirements CLIENT may have relating to the Master Production Record, including, without limitation, any information or procedures CLIENT wishes to have incorporated therein. If LONZA desires to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, LONZA will inform CLIENT of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non commercially available materials or technology in the Process.
2.7.2. LONZA will deliver a draft version of the Master Production Record to CLIENT for its review and approval in accordance with the schedule set forth in the Statement of Work. CLIENT will notify LONZA in writing of any objections it has to the Master Production Record, and upon such notification, representatives of LONZA and CLIENT will meet promptly to resolve such objections. Upon CLIENT's written notification to LONZA that the draft Master Production Record is satisfactory, such draft will be deemed approved by CLIENT.
2.7.3. The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any LONZA Operating Documents or LONZA Confidential Information included in any of the foregoing, will be deemed CLIENT Confidential Information and subject to the provisions set forth in Article 8. LONZA shall not include any necessary LONZA Intellectual Property and/or Confidential Information in the Process, Master Production Record or Specifications without CLIENT's prior written consent. CLIENT and its Affiliates shall be permitted to use (itself or, subject to Section 9.2.2 through a Third Party, subject to the terms of this Agreement) the Process and/or the Master Production Record to manufacture Product; provided, however, that if the Process and/or the Master Production Record incorporates or contains any LONZA Intellectual Property or LONZA Confidential Information, prior to any disclosure of such LONZA Intellectual Property or LONZA Confidential Information to, or use by, a Third Party manufacturer, CLIENT shall obtain LONZA'...
Master Production Record. Subject to the terms and conditions of this Agreement, CBL agrees to produce Product in accordance with a Master Batch Record approved in writing by ImmuLogic. CBL further agrees that any substantive changes to the Master Batch Record and the production process must receive written approval of ImmuLogic prior to implementation, provided, however, that any approvals shall not be unreasonably withheld by ImmuLogic and the parties shall cooperate and act reasonably and in good faith in connection with their respective activities under this Section.
Master Production Record. Inex SOP 1202.28-RO Manufacturing of Vincristine Sulfate Liposomes Injection (14.2 mg/mL) (incorporated by reference) *** Indicates the omission of confidential material pursuant to a request for confidential treatment made in accordance with Rule 24b-2 under the Securities Exchange Act of 1934, as amended. The Confidential material is being filed separately with the Secretary to the Securities and Exchange Commission.
Master Production Record. Any proposed change to the Master Production Record must be approved by both parties. No revisions to the Master Production Record that would affect the Processing of the API or Deliverables shall be submitted to the FDA unless approved by both parties in writing. Both parties acknowledge that implementation due to changes may delay Processing.
Master Production Record. [*] [*] [*] [*] [*]
