Clinical Batches Clause Samples
The 'Clinical Batches' clause defines the requirements and procedures for producing, handling, and delivering batches of a product intended for use in clinical trials. It typically outlines specifications such as quality standards, manufacturing processes, timelines for delivery, and documentation obligations related to these batches. For example, it may require that each batch meets certain regulatory standards and is accompanied by certificates of analysis before being supplied to a clinical site. The core function of this clause is to ensure that all clinical trial materials are consistently produced and controlled, thereby safeguarding patient safety and supporting regulatory compliance.
Clinical Batches. Following TRANSMEDICS acceptance of the Research & Development Report, if FRESENIUS and TRANSMEDICS so agree, FRESENIUS shall produce one or more Clinical Batches of the Products. FRESENIUS will manufacture batches according to its typical batch size ([***] units) only. TRANSMEDICS shall inform FRESENIUS of the number of Batches required 90 days before delivery.
Clinical Batches. CBSB shall perform all Clinical Runs required to manufacture Clinical Batches at 1,000L scale in accordance with the Project Scope, the Project Schedule and Budget and the Master Production Record or as otherwise directed by Tercica in writing and mutually agreed to by the Parties. CBSB will provide, to Tercica, the cGMP manufacturing services to produce such Clinical Runs and Clinical Batches on a time and materials basis as set forth in Section 8.3 and in accordance with the delivery terms set forth in Section 7.4. Subject to the provisions of Article 13, Tercica shall have no obligation to pay for, and CBSB shall replace, at CBSB’s cost, any Non-Conforming Drug Substance resulting from any Clinical Run. CBSB shall have no liability or obligation whatsoever with respect to Drug Substance resulting from any Clinical Run for any reason other than CBSB’s breach of the warranty terms set forth in Section 17.1 or Section 17.2.
Clinical Batches. The Parties recognize and agree that, due to the early stage in development of manufacturing processes for products still in preclinical development or in clinical trials, batch failures (meaning a nonconformity of a batch of a particular product to the specifications therefor at any stage in the manufacturing process) may occur in Gilead's manufacture of Products for supply to OSI as clinical supplies hereunder, and that such batch failures are an inherent risk associated with products in this stage of development. If such a batch failure occurs, Gilead shall schedule a new manufacturing run to replace the failed batch as soon as is reasonably practicable and shall not be in breach of this Manufacturing Agreement if it fails to meet the original Delivery Date for the shipment affected by the failed batch. Gilead's Development Costs associated with manufacturing any failed batch shall be paid to Gilead by OSI in the same manner as all other Development Costs (as provided in Section 9.6). After any clinical batch failure, Gilead shall, in consultation with the applicable Development Team, schedule a new production run to replace the failed batch as soon as is reasonably practicable. For ** per year per Product, the Development Team for such Product -------------- ** This portion has been redacted pursuant to a confidential treatment request. shall not be required to amend the Work Plan and Budget then in effect to specifically allow a production run to manufacture quantities of the Product required to replace the failed **, and Gilead's Development Costs to manufacture ** of such Product to replace the failed ** shall be deemed to have been included in the applicable Work Plan and Budget and paid to Gilead by OSI in accordance with Section 9.6 in addition to any amounts due to Gilead for production of the failed **. If there is more than ** of a Product in a calendar year, then the applicable Development Team shall meet to revise the applicable Work Plan and Budget to accommodate additional production runs as desired by the Parties, and Gilead shall not be required to supply quantities of the relevant Product that were to come from the batch that failed unless the Development Team so amends the applicable Work Plan and Budget.
Clinical Batches. The Subject Matter of the processing of Personal Data comprises the following data types/categories: full or partial date of birth, name or initials, weight, NOVARTIS patient number, site number(s)
Clinical Batches. As requested by Company and covered in a Work Order, Supplier will produce Clinical Batches to be used in clinical trials in US or/ and ex US. Product can be filled in either [*] or [*]. Assuming that Batches are run at Full Scale, the price of each Clinical Batch will be billed to Company at a rate of $[*]/[*]. If a smaller scale batch is requested by Company, the per [*] price will be adjusted appropriately. Under no circumstances will the per Batch price be less than $[*]. Testing, raw materials (excluding [*] and [*]) and Batch Record Documentation of Clinical Batches will be covered in this pricing. The price of these [*] will count toward the Monthly Fees covered in Section 10.7. If the Clinical Batch Product is out-of-specification (OOS), Company will still be responsible for the price of Batch unless the root cause of the OOS is material and is directly related to Supplier’s failure to follow the manufacturing process or testing instructions that are covered in the agreed upon Batch Records or transferred test methods, respectively.