Release of Product. OraPharma shall be responsible for the decision ------------------ to release Product for distribution and sale under this Agreement.
Release of Product. GENETHON is responsible for certifying each Product batch, according to the criteria described in GMP, annex 13. GENSIGHT is responsible for the final release of each Product batch, i.e. authorization to use the Product batch in the clinical trial. GENSIGHT will provide documentation to GENETHON of release authorization for each Product batch. The final release performed by GENSIGHT allows GENETHON to ship the Product batch to the clinical center or distributor designated by GENSIGHT in accordance with Section 9.8 and under GENSIGHT sole responsibility. All information necessary for GENSIGHT to take a final decision regarding the release of each Product batch will be available to GENSIGHT on site at GENETHON Facility while one copy of document could be provided upon request duly justified (i.e. critical deviation, OOS event, batch rejection).
Release of Product. Formosa QA will review all applicable test results and batch records for each isolated intermediate during a manufacturing run and perform manufacturer’s release before the intermediate can be used in the next production step. Formosa will perform the manufacturer’s release of each batch of API. Formosa will provide copies to NGX of all documentation outlined in Section “Batch Accompanying Documentation”, for each batch produced, no later than [***] from completion of manufacture of the batch. NGX will perform a comprehensive review of the documentation and inform Formosa of any quality or regulatory issues identified during the review. [***] NGX QA will perform the final release of the API batch for further manufacturing for clinical or commercial use. NGX will inform Formosa of acceptance or rejection of the batch.
Release of Product. Each Credit Party will either (a) release each Completed item of Product in the United States in the market for which it is intended within twelve (12) months of delivery or (b) revise the ultimates for such item of Product and immediately write down the negative cost of such item of Product in accordance with GAAP. Without limiting and in addition to the foregoing, in the event a Credit Party fails to release a Completed item of Product in the market for which it is intended within twelve (12) months of delivery, the ultimates for such item of Product shall be immediately revised by the Borrower or such Credit Party, as applicable, to exclude such item of Product therefrom until such time, if ever, as such item of Product is released as provided in the first sentence of this Section 5.24. In addition to the foregoing, if at any time any Credit Party determines in accordance with GAAP that the ultimates for an item of Product previously included in the Borrowing Base have decreased, then the Borrower or such Credit Party shall revise the ultimates for such item of Product, and accordingly, reflect such write down in the next quarterly Borrowing Base Certificate delivered to the Administrative Agent in accordance with this Section 5.24.
Release of Product. 5.1.1. BI Austria shall be responsible for the RELEASE of PRODUCT according to the PRODUCT SPECIFICATIONS, the cGMP requirements, the QUALITY ASSURANCE REQUIREMENTS as listed in EXHIBIT 10 and all applicable Austrian and German laws. BI Austria shall certify in writing that each shipment lot of PRODUCT was produced and tested in compliance with (i) the SPECIFICATIONS, (ii) the cGMP requirements (iii) QUALITY ASSURANCE REQUIREMENTS and (iv) all applicable laws, regulations and ordinances of the jurisdiction in which such manufacture occurs.
5.1.2. BI Austria shall provide to InterMune, through BI Pharma KG, QUALITY ASSURANCE REQUIREMENTS as listed in EXHIBIT 10 including but not limited to a COA and COC signed by the appropriate personnel as defined in BI Austria's Quality Management System for each shipment lot of PRODUCT from BI Pharma KG's manufacture site in Biberach, Germany, in order to prove BI Austria's compliance with the Article 5.1.1.
Release of Product. 8.1 If (i) the tests and other quality control measures have shown that the batch of Product meets the required quality and are in compliance with the product specifications, (ii) the manufacturing Batch Records have been duly signed, and (iii) the Batch Record has been approved by PISA’s Qualified Person, PISA shall release the batch for delivery and shall furnish NxStage with a Certificate of Analysis (“C of A”), as signed by PISA’s Qualified Person. The format of the C of A will be agreed upon by NxStage Quality Assurance. For handling of deviations from specified processes in the manufacture or testing of the Products refer to clause 6.5 of this Agreement
8.2.1 NxStage shall be responsible for release of the Product for commercial sale (final release).
8.2.2 Should there be a discrepancy between test results carried out by each party, and if both parties do not find a mutually agreeable solution, such discrepancies shall be finally resolved by testing performed by an independent third party mutually agreed upon by both parties. The costs of such testing shall be borne by the party against whom the discrepancy is resolved.
Release of Product. Batch Certification for Shipment (QP confirmation) (X) X 4.8.2 Product Release to the market X 4.8.3 Certificate of Compliance and Certificate of Analysis X
Release of Product. 6.1 The Qualified Person of EUROGENTEC will review each single Manufacturing Batch Record for compliance with the Process Document. EUROGENTEC will release each single batch for shipment to ESPERION only after full compliance of the batch documentation with the Process Document. He will notify ESPERION of any significant deviation prior to release and shipment.
6.2 The Qualified Person of EUROGENTEC will notify the release of each single batch to ESPERION by means of a product specific release certificate limited to the manufacturing specifications and the specifications of the controls being performed by EUROGENTEC or by an external contractor under its responsibility.
6.3 An appropriate number of samples of Product or amount of intermediate active ingredient, as specified in the Specification Document, will be conserved by EUROGENTEC for retesting in case of disagreement between EUROGENTEC and ESPERION about EUROGENTEC' responsibility in Product failure to conform to the product specifications.
Release of Product. 9.1 If (i) the tests and other quality control measures have shown that the batch of Product meets the required quality and are in compliance with the product specifications, (ii) the manufacturing and test protocols have been duly signed, and (iii) the batch file has been approved by BMT's Qualified Person, BMT shall release the batch for delivery and shall furnish NxStage with a certificate of analysis, as signed by BMT's Qualified Person. For handling of deviations from specified processes in the manufacture or testing of the Products refer to clause 7.3 of this Agreement.
9.2 NxStage shall be responsible for release of the Product for commercial sale (final release).
Release of Product. 6.4.1 If Customer gains possession of product prior to return of microbiological testing results to VPH (a Rolling Release) or if instructed to hold product for any other reason by VPH, Customer agrees to hold product until notified by VPH of a passing test or further instruction. If Customer breaches this term, VPH will be released from liability for any and all damages related to the release and Customer will be responsible for all costs, losses and damages incurred by VPH including, but not limited to, costs associated with any legal actions, loss of business and any associated fees or fines.
6.4.2 VPH is not responsible or liable for the use, distribution, sale or any other disbursement, legal or otherwise, of samples provided by VPH to Customer. However, VPH will be liable for harm caused by a defect directly associated with a failure in VPH’s food safety program while producing requested samples only to the extent that disbursement of sample by Customer was legal.
