Common use of Approval of Completed Product Clause in Contracts

Approval of Completed Product. 5.2.1 When a Statement of Work has been completed, LHI will notify CLIENT and supply CLIENT with the required documentation set forth in the Statement of Work. 5.2.2 Within twenty one (21) calendar days after CLIENT’s receipt of substantially complete documentation and Batch Records regarding such Product (the “Acceptance Period”), Client shall determine by review of such documentation whether or not the given Batch conforms to the product warranties set forth in Section 5.1 above (“Product Warranties”). If CLIENT asserts that the Product does not comply with the Product Warranties set forth in Section 5.1 above, CLIENT will deliver to LHI, in accordance with the notice provisions set forth in Section 17.4 hereof, written notice of disapproval (the “Disapproval Notice”) of such Product, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LHI during the Acceptance Period, then LHI 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 the Product and the Disapproval Notice. If a valid Disapproval Notice is not received during the Acceptance Period, the Product will be deemed accepted and ready for shipment to CLIENT, or storage for CLIENT, as applicable. If Product is to be shipped to CLIENT, then upon acceptance, the Product shall be delivered to CLIENT, and CLIENT shall accept delivery thereof, within 10-days after such acceptance. Title and risk of loss to such Product shall pass to CLIENT at the time of delivery to the common carrier pursuant to Section 4.4. If the Product is to be stored by LHI for CLIENT, LHI shall do so in accordance with agreed upon terms of a Statement of Work which covers all relevant details of a Product storage engagement.

Approval of Completed Product. 5.2.1 6.2.1 Prior to each release by LONZA of Product to be supplied 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 released conforms to the Product Warranties. When a Statement of Work has been completedProduct ordered by CLIENT is ready for release, LHI LONZA will notify CLIENT and supply CLIENT with the required documentation set forth in Exhibit 6.2, including a copy of the Statement executed Batch Records and a certificate of Work. 5.2.2 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 released has been manufactured, controlled and released according to the Specifications (other than for Engineering Batches), Master Production Record, cGMP, and all Applicable Laws. Within twenty one (21) calendar days [***] after CLIENT’s receipt of substantially complete such documentation and Batch Records regarding such Product (the “Acceptance Period”), Client CLIENT shall determine by review of such documentation whether or not such Product meets the given Batch conforms Product Warranties in order to the product warranties set forth in Section 5.1 above (“Product Warranties”)approve release of such Product. If CLIENT asserts that the Product does not comply with the Product Warranties set forth in Section 5.1 6.1 above, CLIENT will deliver to LHILONZA, in accordance with the notice provisions set forth in Section 17.4 16.4 hereof, written notice of disapproval (the “Disapproval Notice”) of such ProductProduct 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 LHI LONZA during the Acceptance Period, then LHI such Product shall not be released and 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 the such Product and the Disapproval Notice. If a valid Disapproval Notice is not received during the Acceptance Period, the such Product will be deemed released, accepted and ready for shipment to CLIENT, or storage for CLIENT, as applicable. If Product is to be shipped to CLIENT, then upon acceptance, the Product shall be delivered to CLIENT, and CLIENT shall accept delivery thereof, within 10-days after such acceptance. Title and risk of loss to such Product shall pass to CLIENT at the time of Product release by LONZA. Nothing herein shall limit CLIENT’s rights and remedies under the rest of this Agreement. 6.2.2 LONZA shall store Product accepted in accordance with Section 6.2.1 at CLIENT’s request for up to [***] following such acceptance at no cost to CLIENT. Maximum storage duration shall not exceed [***] following LONZA’s release of the Product, and LONZA shall have no responsibility or liability for storing Product after [***] after release of the Product unless otherwise agreed by the Parties in writing. Product accepted in accordance with Section 6.2.1 shall be delivered to CLIENT or its designee in accordance with Section 5.6 above. CLIENT may reject all or part of the shipment within[***] of delivery by providing a Disapproval Notice as provided in Section 6.2.1. The shipment of Product shall be deemed accepted if CLIENT fails to reject the Product within such [***] period. Notwithstanding anything to the common carrier contrary, CLIENT shall have the further right to reject quantities of Product accepted pursuant to Section 4.4. If 6.2.1 or this Section 6.2.2 if it reasonably determines that all or part of the shipment fails to comply with the Product Warranties, provided such non-conformance could not have reasonably been determined by a visual inspection and is not due to shipping or storage of the Product by CLIENT or its designee after delivery by LONZA (a “Latent Defect”) and CLIENT provides a Disapproval Notice related thereto. Any Disapproval Notice for a Latent Defect shall be stored by LHI for provided within [***] of the discovery of any such Latent Defect, but in no event later than [***] after delivery of the applicable Product to CLIENT, LHI shall do so in accordance with agreed upon terms of a Statement of Work which covers all relevant details of a Product storage engagement.

Approval of Completed Product. 5.2.1 When a Statement of Work cGMP Batch has been completed, LHI LONZA will notify CLIENT and supply CLIENT with the required documentation Project Documentation set forth in the Statement of Work. 5.2.2 SOW. Within twenty one (21) calendar days [***] after CLIENT’s receipt of substantially complete such documentation and Batch Records regarding such Product cGMP Batch (the “Acceptance Period”), Client shall determine by review of such documentation whether or not the given cGMP Batch conforms to the product warranties set forth in Section 5.1 above (“Product Warranties”). If CLIENT asserts that the Product cGMP Batch does not comply with the Product Warranties set forth in Section 5.1 above, CLIENT will deliver to LHILONZA, in accordance with the notice provisions set forth in Section 17.4 hereof, written notice of disapproval (the “Disapproval Notice”) of such ProductcGMP Batch, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LHI LONZA during the Acceptance Period, then LHI 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 the Product cGMP Batch and the Disapproval Notice. If a valid Disapproval Notice is not received during the Acceptance Period[***], the Product cGMP Batch will be deemed accepted and ready for shipment to CLIENT, or storage for CLIENT, as applicable. [***] 5.2.2 If Product is to be shipped to CLIENT, then upon acceptance, the Product shall be delivered to CLIENT, and CLIENT shall accept delivery thereof, within 10-days [***] after such acceptance. Title and risk of loss to such Product shall pass to CLIENT at the time of delivery to the common carrier pursuant to Section 4.4[***]. If the Product is to be stored by LHI LONZA for CLIENT, LHI LONZA shall do so in accordance with agreed upon terms of a Statement of Work SOW which covers all relevant details of a Product storage engagement.

Approval of Completed Product. 5.2.1 When a Statement of Work cGMP Batch has been completed, LHI LONZA will notify CLIENT and supply CLIENT with the required documentation Project Documentation set forth in the Statement of Work. 5.2.2 SOW. Within twenty one (21) calendar days [***] after CLIENT’s receipt of substantially complete such documentation and Batch Records regarding such Product cGMP Batch (the “Acceptance Period”), Client CLIENT shall determine by review of such documentation whether or not the given cGMP Batch conforms to the product warranties set forth in Section 5.1 above (“Product Warranties”). If CLIENT asserts that the Product cGMP Batch does not comply with the Product Warranties set forth in Section 5.1 above, CLIENT will deliver to LHILONZA, in accordance with the notice provisions set forth in Section 17.4 hereof, written notice of disapproval (the “Disapproval Notice”) of such ProductcGMP Batch, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LHI LONZA during the Acceptance Period, then LHI 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 or testing of the cGMP Batch. If a valid Disapproval Notice is not received during the Acceptance Period, the cGMP Batch will be deemed accepted and ready for shipment to CLIENT, or storage for CLIENT, as applicable. 5.2.2 If Product is to be shipped to CLIENT, then upon acceptance, the Product shall be delivered to CLIENT, and CLIENT shall accept delivery thereof, within [***] after such acceptance. Title and risk of loss to such Product shall pass to CLIENT at the time of delivery to the common carrier pursuant to Section 4.6. If the Product is to be stored by LONZA for CLIENT, LONZA shall do so in accordance with agreed upon terms of a SOW which covers all relevant details of a Product storage engagement. 5.2.3 Notwithstanding anything to the contrary, CLIENT shall have the further right to reject quantities of Product accepted pursuant to Section 5.2.1 or Section 5.2.2 if it [***], provided such non-conformance could not have [***] been discoverable upon the inspection and testing by LONZA and CLIENT that would have been expected in the ordinary course of Product release and disposition, but is discovered at a later time and [***] (a “Latent Defect”) and CLIENT provides a Disapproval Notice related thereto. Any Disapproval Notice for a Latent Defect shall be provided within [***] of the discovery of any such Latent Defect, but in no event later than [***] after delivery of the applicable Product to CLIENT. If a Disapproval Notice is received by LONZA during such 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 the Product and the Disapproval Notice. If a valid Disapproval Notice is not received during the Acceptance Period, the Product will be deemed accepted and ready for shipment to CLIENT, or storage for CLIENT, as applicable. If Product is to be shipped to CLIENT, then upon acceptance, the Product shall be delivered to CLIENT, and CLIENT shall accept delivery thereof, within 10-days after such acceptance. Title and risk of loss to such Product shall pass to CLIENT at the time of delivery to the common carrier pursuant to Section 4.4. If the Product is to be stored by LHI for CLIENT, LHI shall do so in accordance with agreed upon terms of a Statement of Work which covers all relevant details of a Product storage engagement.

Approval of Completed Product. 5.2.1 When a Statement of Work cGMP Batch has been completed, LHI LONZA will notify CLIENT and supply CLIENT with the required documentation Project Documentation set forth in [***] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed. the Statement of Work. 5.2.2 SOW. Within twenty one (21) [***] calendar days after CLIENT’s receipt of substantially complete documentation and Batch Records such Project Documentation regarding such Product cGMP Batch (the “Acceptance Period”), Client shall determine by review of such documentation Project Documentation whether or not the given cGMP Batch conforms to the product warranties set forth in Section 5.1 above (“Product Warranties”). During the Acceptance Period, LONZA shall respond promptly to any reasonable inquiry by CLIENT with respect to such Project Documentation. If CLIENT asserts that the Product cGMP Batch does not comply with the Product Warranties set forth in Section 5.1 above, CLIENT will deliver to LHILONZA, in accordance with the notice provisions set forth in Section 17.4 hereof, written notice of disapproval (the “Disapproval Notice”) of such ProductcGMP Batch, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by LHI LONZA during the Acceptance Period, then LHI 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 the Product cGMP Batch and the Disapproval Notice. If a valid Disapproval Notice is not received during the Acceptance Period, the Product cGMP Batch will be deemed accepted and ready for shipment to CLIENT, or storage for CLIENT, as applicable. . 5.2.2 If Product is to be shipped to CLIENT, then upon acceptance, the Product shall be delivered to CLIENT, and CLIENT shall accept delivery thereof, within 10-days [***] after such acceptance. Title and risk of loss to such Product shall pass to CLIENT at the time of delivery to the common carrier pursuant to Section 4.4[***]. If the Product is to be stored by LHI LONZA for CLIENT, LHI LONZA shall do so in accordance with agreed upon terms of a Statement of Work SOW which covers all relevant details of a Product storage engagement.