Non-Conforming Drug Product Sample Clauses

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, AXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to ALTHEA’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”). 5.1.1 If (a) any Batch of Drug Product conforms to the Product Requirements, or (b) CLIENT fails to notify AXXXXX within the applicable time period that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 If CLIENT believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to AXXXXX. Upon receipt of such notice, AXXXXX will investigate such alleged non-conformity, and (i) if AXXXXX agrees such Drug Product is non-conforming, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt of CLIENT’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXX, or (ii) if AXXXXX disagrees with CLIENT’s determination that the Batch of Drug Product is non-conforming, AXXXXX shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery. 5.1.3 If the parties dispute whether Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. CLIENT shall bear the costs of such laboratory or consultant, except as set forth in Section 5.2.

Non-Conforming Drug Product. In the event Aclaris and/or its agent(s) believes that the Drug Product are defective or do not conform to the Specifications set forth herein (“Non-Conforming Drug Product”), Aclaris shall send to Xxxxx Xxxxxxxxx via overnight delivery service or certified mail, return receipt requested, within five (5) Business Days of discovery of the defect, a notice of rejection along with samples of the rejected Drug Product. If Xxxxx Xxxxxxxxx agrees that the Drug Product are Non-Conforming Drug Product, Xxxxx Xxxxxxxxx, at Aclaris’ option, will either Manufacture new Drug Product, at Xxxxx Xxxxxxxxx’x expense, and ship them to Aclaris within a commercially reasonable timeframe subject to Xxxxx Xxxxxxxxx’x capacity, or shall issue a full refund for that particular lot to Aclaris within thirty (30) calendar days from the date of Aclaris’ request for same. If Xxxxx Xxxxxxxxx does not agree with Aclaris’ determination that the Drug Product fail to meet the Specifications, then after reasonable efforts to resolve the disagreement, either Party may pursue available remedies under this Agreement; provided, however, Xxxxx Xxxxxxxxx must inform Aclaris within ten (10) Business Days if Xxxxx Xxxxxxxxx determines that the Drug Product rejected by Aclaris met the Specifications.