Common use of Lot Documentation Clause in Contracts

Lot Documentation. If, based upon the tests and documentation review performed under Section 6.1, a LOT conforms to the Specifications and was Manufactured according to GMP (if applicable) and the Manufacturing Protocol, then a Certificate of Compliance shall be completed and approved by the quality assurance department of SR. Such Certificate of Compliance, a Certificate of Analysis, the Specifications, and a copy of the LOT records (collectively, the “LOT Documentation”) for each LOT shall be transferred to CorneaGen. Within [***] in Japan after the receipt of LOT Documentation, CorneaGen shall, by itself or through its designee, confirm the accuracy of the description of the LOT Documentation. If CorneaGen finds there is any deficiency in the LOT Documentation, CorneaGen shall notify SR of such deficiency no later than [***] in Japan after completion of the confirming the LOT Documentation. If CorneaGen fails to provide a notification to SR within [***] in Japan after the receipt of the LOT Documentation, such LOT Documentation shall be deemed to have been accepted by CorneaGen. If CorneaGen requires additional copies of such LOT Documentation, these shall be provided by SR to CorneaGen at CorneaGen’s sole costs and expenses following CorneaGen’s written request.