Common use of Approval of Shipment Clause in Contracts

Approval of Shipment. 6.2.1 Prior to each release of Product to be delivered hereunder, LONZA will perform appropriate quality control procedures and inspections (including any such procedures and inspections specified in the Specifications therefor) to verify that such Product to be shipped conforms to the Product Warranties. When Product ordered by CLIENT is ready for delivery, LONZA will notify CLIENT and supply CLIENT with the required documentation set forth in the applicable Statement of Work, including a copy of the executed Batch Records and a certificate of analysis, in the form specified in the applicable Specifications, describing all current requirements of such Specifications and results of tests performed certifying that such Product to be shipped has been manufactured, controlled and released according to the Specifications, Master Production Record, cGMP, and all Applicable Laws (the “Release Documentation”). 6.2.2 Within fifteen (15) calendar days after CLIENT’s or its designee’s receipt of Release Documentation regarding a release of Product (the “Non-Release Period”), CLIENT shall determine by review of such Release Document whether or not to approve such release of the Product. If CLIENT believes such shipment of Product does not comply with the Product Warranties set forth in Section 6.1 above, then CLIENT will deliver to LONZA, in accordance with the notice provisions set forth in Section 19.3 hereof, written notice of disapproval (the “Disapproval Notice”) of such Product release, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LONZA during the Non-Release Period, then LONZA and CLIENT will provide one another with all related paperwork and records (including, but not limited to, quality control tests) relating to both the production of such shipment of Product and the Disapproval Notice. If a valid Disapproval Notice is not received during the Non-Release Period, then the shipment of Product will be deemed released and approved for shipment. Notwithstanding the foregoing, any such release and approval for shipment pursuant to this Section 6.2.2 shall not limit CLIENT’s rights and remedies under the rest of this Article 6.

Approval of Shipment. 6.2.1 Prior to each release of Product to be delivered hereunder, LONZA will perform appropriate quality control procedures and inspections (including any such procedures and inspections specified in 5.2.1 When the Specifications therefor) to verify that such Product to be shipped conforms to the Product Warranties. When Product ordered by CLIENT TiGenix is ready for delivery, LONZA LWI will notify CLIENT TiGenix and supply CLIENT TiGenix with the required documentation set forth in the applicable Statement of Work, including a copy of the executed Batch Records and a certificate of analysis, in the form specified in the applicable Specifications, describing all current requirements of such Specifications and results of tests performed certifying that such Product to be shipped has been manufactured, controlled and released according to the Specifications, Master Production Record, cGMP, and all Applicable Laws (the “Release Documentation”). 6.2.2 5.2.2 Within fifteen ten (1510) calendar days after CLIENT’s or its designeeTiGenix’s receipt of Release Documentation such documentation regarding a release of such Product (the “Non-Release Acceptance Period”), CLIENT TiGenix shall determine by review of such Release Document documentation whether or not the given Batch conforms to approve such release of the Productproduct warranties set forth in Section 5.1 above (“Product Warranties”). If CLIENT believes such shipment of TiGenix asserts that the Product does not comply with the Product Warranties set forth in Section 6.1 5.1 above, then CLIENT TiGenix will deliver to LONZALWI, in accordance with the notice provisions set forth in Section 19.3 17.4 hereof, written notice of disapproval (the “Disapproval Notice”) of such Product releaseProduct, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LONZA LWI during the Non-Release Acceptance Period, then LONZA LWI and CLIENT TiGenix will provide one another with all related paperwork and records (including, but not limited to, quality control tests) relating to both the production of such shipment of the Product and the Disapproval Notice. If a valid Disapproval Notice is not received during the Non-Release Acceptance Period, then the shipment of Product will be deemed released accepted and approved ready for shipment. Notwithstanding Upon acceptance, the foregoingProduct shall be delivered to TiGenix, and TiGenix shall accept delivery thereof, within two (2) days after such acceptance. The foregoing notwithstanding, TiGenix may reject a Product by providing a Disapproval Notice within three (3) months of the date of delivery if the reason why such Product does not conform to the Product Warranties (as they were in effect at the time of production) is a Latent Defect. If no such Latent Defect claim is received by LWI within such three (3) month period, the Products delivered shall be deemed to be accepted by TiGenix and considered free of defects upon delivery. Title and risk of loss to such Product shall pass to TiGenix at the time of delivery to the common carrier pursuant to Section 4.4. For the purposes of this Section 5.2, “Latent Defect” shall mean, with respect to any Product supplied by LWI under this Agreement, defects in the Product that existed at the time of delivery to TiGenix but could not be reasonably detected upon initial inspection of the Product which cause such release and approval for shipment Product to fail to conform to the Product Warranties at the time of delivery. For the avoidance of doubt, acceptance of a Product Batch by TiGenix pursuant to this Section 6.2.2 5.2 shall not limit CLIENTTiGenix’s other rights and remedies under this Agreement (including LWI’s indemnification obligations hereunder) solely if, within ninety (90) days from the rest date of delivery, TiGenix provides LWI a Disapproval Notice relating to such Latent Defect. By way of derogation from Section 2.1, if a certain Statement of Work sets forth an acceptance process which differs from the process described in this Article 6Section 5.2, the terms in such Statement of Work will prevail.

Approval of Shipment. 6.2.1 Prior to each release of Product to be delivered hereunder, LONZA will perform appropriate quality control procedures and inspections (including any such procedures and inspections specified in 5.2.1 When the Specifications therefor) to verify that such Product to be shipped conforms to the Product Warranties. When Product ordered by CLIENT is ready for delivery, LONZA LWI will notify CLIENT and supply CLIENT with the required documentation set forth in Batch Documentation. If a Batch of Product conforms to the applicable Statement Product Warranties, then a certificate of Workcompliance will be completed and approved by LWI. This certificate of compliance, including a copy of the executed Batch Records and a certificate of analysis, in the form specified in the applicable Specifications, describing all current requirements of such Specifications and results of tests performed certifying that such Product to be shipped has been manufactured, controlled and released according to the Specifications, Master Production Record, cGMPa complete and accurate copy of the consolidated Batch Records, and all Applicable Laws the Process description (collectively, the “Release Batch Documentation”)) for such Batch of Product will be provided to CLIENT within [ * ] calendar days of completing testing, either electronically through a secure portal or by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon request, LWI will also provide CLIENT with all results relating to the manufacture of each Batch of Product, which results are set forth in the Batch Record. 6.2.2 5.2.2 Within fifteen (15) [ * ] calendar days after CLIENT’s or its designee’s receipt of Release such Batch Documentation regarding a release of such Product (the “Non-Release Acceptance Period”), CLIENT shall determine by review of such Release Document Batch Documentation whether or not the Batch Documentation reflects that the given Batch conforms to approve such release of the Product. If CLIENT believes such shipment of Product does not comply with the Product Warranties set forth in Section 6.1 5.1 above, then CLIENT will deliver except to LONZA, in accordance with the notice provisions set forth in Section 19.3 hereof, written notice of disapproval (the “Disapproval Notice”) of extent a warranty cannot be confirmed by reviewing such Product release, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LONZA during the Non-Release Period, then LONZA and CLIENT will provide one another with all related paperwork and records (including, but not limited to, quality control tests) relating to both the production of such shipment of Product and the Disapproval Notice. If a valid Disapproval Notice is not received during the Non-Release Period, then the shipment of Product will be deemed released and approved for shipmentdocumentation. Notwithstanding the foregoing, any if CLIENT reasonably requests to extend the Acceptance Period and its review of the Batch Documentation has commenced and CLIENT is diligently reviewing the Batch Documentation within such release [ * ]-day period, the Acceptance Period shall be extended to a period not to exceed [ * ] days, so long as the CLIENT is making diligent efforts, and approval for shipment pursuant to this Section 6.2.2 shall not limit CLIENT’s rights and remedies under the rest of this Article 6assuming LWI cooperates fully therewith.