Common use of Non-Conformities Clause in Contracts

Non-Conformities. If NUVELO believes a Batch of Drug Product does not conform to the Product Requirements, or if NUVELO believes that [ * ] that occurs after the relevant Project Plan was executed by the Parties (except [ * ] pursuant to this Section 6.1.2), caused the Drug Product to not meet [ * ] that were [ * ] (any such failure(s) or change(s) referred to individually as a “Non-conformity,” a Batch Produced with a Non-Conformity referred to as “Non-conforming”), NUVELO shall notify BPS in a writing setting forth a detailed description of why the Batch of Drug Product is Non-conforming and provide such written documentation to BPS via overnight courier delivery. Upon receipt of such notice, BPS will investigate such alleged Non-conformity, and: (i) if BPS agrees such Drug Product is Non-conforming, deliver to NUVELO a detailed corrective action plan with an estimated timeline for such corrections within [ * ] days after receipt of NUVELO’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 NUVELO or BPS, but in no case longer than the time established in Section 6.2 or (ii) if BPS disagrees with NUVELO’s determination that the Batch of Drug Product is Non-conforming, BPS shall so notify NUVELO of the dispute in writing [ * ] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. within [ * ] days after receipt of NUVELO’s notice of Non-conformity (any such dispute, and any dispute regarding the cause, or causes, of a Non-Conformity, referred to as a “Batch Dispute”). Notwithstanding any other language in this Article, NUVELO is [ * ] and approved [ * ]; and BPS is not responsible for [ * ], so long as: (a) [ * ]; (b) [ * ] and (c) [ * ], NUVELO has [ * ]. If BPS [ * ] NUVELO [ * ], BPS shall have [ * ] days from receipt thereof to notify NUVELO in writing or Electronically that BPS [ * ] or will [ * ]. If NUVELO does not receive [ * ] from BPS before the expiration of [ * ] days after [ * ], NUVELO may, in its discretion, no later than [ * ] days after [ * ], send BPS a notice of termination of the Agreement in accordance with Section 4.2.2.2, which termination shall become effective [ * ] days after receipt of the notice of termination by BPS. Once BPS receives [ * ], BPS shall not [ * ] until the earlier of [ * ] NUVELO to [ * ] of the [ * ] the expiration of [ * ] days after BPS’ receipt of [ * ].