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 CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE REVANCE THERAPEUTICS, INC., HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT REVANCE THERAPEUTICS, INC. TREATS AS PRIVATE AND CONFIDENTIAL. 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.

Related to Clinical Batches

Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.
API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.
Product The term “
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
Product Quality (a) Tesoro warrants that all Products delivered under this Agreement or any Purchaser Order shall meet the latest applicable pipeline specifications for that Product upon receipt at the applicable Terminal and contain no deleterious substances or concentrations of any contaminants that may make it or its components commercially unacceptable in general industry application. Tesoro shall not deliver to any of the Terminals any Products which: (a) would in any way be injurious to any of the Terminals; (b) would render any of the Terminals unfit for the proper storage of similar Products; (c) would contaminate or otherwise downgrade the quality of the Products stored in commingled storage; (d) may not be lawfully stored at the Terminals; or (e) otherwise do not meet applicable Product specifications for such Product that are customary in the location of the Terminal. If, however, there are Products that do not have such applicable specifications, the specifications shall be mutually agreed upon by the Parties. Should Tesoro's commingled Products not meet or exceed the minimum quality standards set forth in this Agreement or any applicable Purchase Order, Tesoro shall be liable for all loss, damage and cost incurred thereby, including damage to Products of third parties commingled with Tesoro's unfit Products.
Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].
Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.
Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.
Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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