Batch Documentation definition

Batch Documentation has the meaning set forth in Section 6.2.

Batch Documentation means the documentation provided to Myovant or the Qualified Designee (as defined below) at the time of delivery of Drug Substance, as agreed upon by the Parties in the Quality Agreement or as required by Applicable Laws.

Batch Documentation means, for each Batch, the Certificate of Compliance and the Certificate of Analysis.

Examples of Batch Documentation in a sentence

• Prior to the delivery of any Batch of Product and within [***] days of completion of such Batch, Manufacturer shall provide Artiva or a third party designated by Artiva with appropriate mutually agreed upon Batch Documentation in accordance with the Work Order.

• If any such Services include a technical process transfer or the production of specific deliverables (including, without limitation, engineering or validation Batches of Product, reports, Master Batch Records, Batch Documentation, and analytical results), the specifications of such technical process transfer or deliverables shall be set forth on the relevant Work Order.

• Artiva will review the Batch Documentation for each Batch of Product.

• Artiva shall pay each undisputed invoice within [***] days of receipt thereof, in accordance with the applicable schedule of payments specified in such Work Order, except in the case of any undisputed invoice for the final payment installment for Batch(es) of Product supplied under a Work Order, which Artiva shall pay within [***] days after approval by Artiva’s Quality Representative of Batch Documentation, the Certificate of Analysis and the Certificate of Compliance for the applicable Batch(es).

• During the [***] review period specified above, the parties agree to respond promptly within [***] days, to any reasonable inquiry by the other party with respect to the Batch Documentation.

More Definitions of Batch Documentation

Batch Documentation means all documentation, records (Batch and testing), deviations, investigations, required retain samples, specifications, databases or other work product generated by Manufacturer during and in connection with production of any Product, whether recorded in writing, electronically, or otherwise.

Batch Documentation means the Certificate of Compliance, the Certificate of Analysis, the Specifications, and a complete and accurate copy of the executed Batch Records.

Batch Documentation means all completed batch records, batch deviations, raw data, reports, authorizations, certificates, raw material specifications, standard test methods, and other documentation in the possession or under the control of a Party (or its vendors) relating exclusively to the Manufacture of each Batch.

Batch Documentation means the documents and other records that are produced in connection with the Manufacture of a particular Batch and/or lot. Batch Documentation includes master manufacturing formula, a listing of raw materials and corresponding specifications, packaging and storage instructions, testing requirements and exception documentation, such as deviations, failures, out-of-specification investigation reports, non-conforming material reports and additional documentation which may have been generated and/or processed as part of the production record of the Batch.

Batch Documentation means, with respect to each non-GMP and GMP Batch delivered hereunder, the batch documentation described in Sections 8.1.1 and 8.1.2, respectively; provided, however, that (i) in no event (and notwithstanding anything to the contrary elsewhere in this Agreement) shall Tekmira be required to provide any Formulation Design Know-How and (ii) subject to the provisions of Sections 11.2 and 11.3 all Batch Documentation, and the provision thereof hereunder shall be subject to the restrictions set forth in the Restated Tekmira LCA and Restated Protiva CLA with respect to the use and sublicensing of Tekmira Technology, Protiva Patent Rights and Licensed Information (as defined in such agreements).

Batch Documentation means a complete copy of the approved executed Batch Record, master Batch Record, release testing results, Certificate of Analysis for Product or Applicator, as applicable, and Certificate of Compliance for Product and Applicator, as applicable.

Batch Documentation means complete and accurate copies of all of the following, as applicable: Albemarle audited production batch records, deviation reports, investigation reports, a COA, Product release chromatographs and corresponding calculations for all batches, management of Change (MOCs), cGMP certificate of compliance, and stability data, when available (including one chromatograph utilizing one condition for each pull interval from one batch). For the sake of clarity, originals of the Batch Documentation will be retained by Albemarle and made available for inspection for all batches produced, including aborted batches, and a complete copy of Batch Documentation shall be furnished to Customer in accordance with Section 3.2.