Common use of Product Conformity Clause in Contracts

Product Conformity. Within fifteen (15) business days from the date of shipment of Product to Celator or the receipt of the Released Executed Batch Record, as defined in Product Master Plan, whichever is later, Celator shall determine whether such Product and related documentation conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator shall have the right to revoke acceptance if, within thirty (30) business days of receipt of the Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of delivery. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator fails to notify Baxter in accordance with the procedures set forth in Section 7.1 that any Product does not conform to the Product Requirements, then Celator shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 If Celator believes Product does not conform to the Product Requirements, it shall notify Baxter by telephone including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier service. Upon receipt of such notice, Baxter will investigate such alleged non-conformity, and (i) if Baxter agrees such Product is non-conforming, Baxter and Celator will mutually determine a corrective action plan within sixty (60) calendar days after receipt of Celator’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 Celator or Baxter, or (ii) if Baxter disagrees with Celator’s determination that the shipment of Product is non-conforming, Baxter shall so notify Celator by telephone within a ten (10) calendar day period and confirm such notice in writing by overnight delivery to Celator. 7.1.3 If the Parties dispute whether Product is conforming or non-conforming to the Product Requirements, the Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faith. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. Within fifteen Subject to Section 9.3 (15Engineering Batches), unless within thirty (30) business calendar days from the date of shipment of Product to Celator or the receipt delivery of the Released Executed Batch RecordDocumentation and any other documentation required by the Quality Agreement for Provider to disposition the Product (the “Inspection Period”), as defined Senti notifies Provider in Product Master Plan, whichever is later, Celator shall determine whether writing (“Exception Notice”) that such Product and related documentation conforms to does not comply with the Product Specifications, Master Batch Record, and Baxter SOPs Requirements (collectively, the “Product RequirementsNonconforming Product”); provided, howeverthen such Product will be deemed to have been accepted, that Celator shall have except in the right case of a Latent Defect. In the case of a Batch having any Latent Defect, Senti may reject such Batch by delivering an Exception Notice to revoke acceptance if, Provider of Senti’s rejection thereof within thirty (30) business days after discovery of such Latent Defect, but such Exception Notice may in no event be given later than the applicable expiration date of such Batch. Upon timely receipt of an Exception Notice from Senti, Provider will conduct an appropriate investigation to determine whether or not it agrees with Senti that the Batchapplicable Product is Nonconforming Product and to determine in good faith the cause of any nonconformity (which investigation shall include an impact assessment on products that Provider or Senti reasonably believes may be an Impacted Product at the relevant time), Celator discovers a latent defect or adulteration not reasonably discoverable at time disclose to Senti the results of delivery. 7.1.1 such investigation, and notify Senti in writing of Provider’s good faith conclusions regarding the cause of the nonconformity. If (a) any Product conforms to the Product RequirementsProvider agrees, or if an independent investigation or analysis conducted pursuant to Section 10.7 (bDisputes as to Failed Batches or Product Conformity) Celator fails to notify Baxter in accordance with determines, that any such Product is a Nonconforming Product and that the procedures cause of the nonconformity is a Provider Processing Default, then Senti shall have the remedies set forth in Section 7.1 that any Product does not conform to the Product Requirements, then Celator shall be deemed to have accepted the Product and waived its right to revoke acceptance10.6 (Remedies). 7.1.2 If Celator believes Product does not conform to the Product Requirements, it shall notify Baxter by telephone including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier service. Upon receipt of such notice, Baxter will investigate such alleged non-conformity, and (i) if Baxter agrees such Product is non-conforming, Baxter and Celator will mutually determine a corrective action plan within sixty (60) calendar days after receipt of Celator’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 Celator or Baxter, or (ii) if Baxter disagrees with Celator’s determination that the shipment of Product is non-conforming, Baxter shall so notify Celator by telephone within a ten (10) calendar day period and confirm such notice in writing by overnight delivery to Celator. 7.1.3 If the Parties dispute whether Product is conforming or non-conforming to the Product Requirements, the Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faith. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. Within fifteen twenty-five (1525) business days from the date of shipment of Product to Celator or the receipt of the and/or Released Executed Batch Record, as defined in Product Master Plan, to Client, whichever is later, Celator Client shall determine whether such Product and related documentation conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); , provided, however, that Celator Client shall have the right to revoke acceptance if, within thirty one hundred and twenty (30120) business days of receipt of the Batch, Celator Client discovers a latent defect or adulteration not reasonably discoverable at time of delivery. Baxter will not ship a Product that Baxter has rejected. 7.1.1 If (a) any shipment of Product conforms to the Product Requirements, or (b) Celator Client fails to notify Baxter in accordance with writing within the procedures set forth in Section 7.1 applicable time periods that any shipment of Product does not conform to the Product RequirementsRequirements due to recognizable defects, then Celator Client shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 If Celator Client believes any shipment of Product does not conform to the Product Requirements, it shall notify Baxter by telephone electronic message including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier servicefacsimile to Baxter. Upon receipt of such notice, Baxter will investigate such alleged non-conformity, and (i) if Baxter agrees such Product is non-conforming, Baxter and Celator Client will mutually determine a corrective action plan within sixty forty-five (6045) calendar days after receipt of CelatorClient’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 Celator Client or Baxter, or (ii) if Baxter disagrees with CelatorClient’s determination that the shipment of Product is non-conforming, Baxter shall so notify Celator Client by telephone within a ten forty-five (1045) calendar day period and confirm such notice in writing by overnight delivery to CelatorClient. 7.1.3 If the Parties dispute whether a shipment of Product is conforming or non-conforming to the Product Requirementsconforming, the shipment of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may Client cannot release a Batch of Product that Baxter has reasonably rejected in good faithrejected. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. Within fifteen [***] (15[***]) business days from the date of shipment receipt by AMYLIN of samples of Product to Celator or [***] ([***]) calendar days from the date of receipt by AMYLIN of the Released Executed Batch Record, as defined in Product Master PlanRecord to AMYLIN, whichever is later, Celator AMYLIN shall determine whether such Product and related documentation conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator shall have the right to revoke acceptance if, within thirty (30) business days of receipt of the Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of delivery. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator . 7.1.1 If AMYLIN fails to notify Baxter in accordance with ▇▇▇▇▇▇ within the procedures set forth applicable time period as specified in Section 7.1 7.1, that any Product Batch does not conform to the Product Requirements, then Celator AMYLIN shall be deemed to have accepted the Product Batch and waived its right to revoke acceptance. 7.1.2 If Celator AMYLIN believes Product any Batch does not conform to the Product Requirements, it shall notify Baxter ▇▇▇▇▇▇ by telephone including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier serviceovernight delivery to ▇▇▇▇▇▇. Upon receipt of such notice, Baxter ▇▇▇▇▇▇, in accordance with the terms of the Quality Agreement, will investigate such alleged non-conformity, and (i) if Baxter ▇▇▇▇▇▇ agrees such Product Batch is non-conforming, Baxter and Celator will mutually determine deliver to AMYLIN a corrective action plan within sixty [***] (60[***]) calendar days after receipt of CelatorAMYLIN’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 Celator AMYLIN or Baxter▇▇▇▇▇▇, or (ii) if Baxter ▇▇▇▇▇▇ disagrees with CelatorAMYLIN’s determination that the shipment of Product Batch is non-conforming, Baxter ▇▇▇▇▇▇ shall so notify Celator AMYLIN by telephone within a ten the [***] (10[***]) calendar day period and confirm such notice in writing by overnight delivery to Celatordelivery. 7.1.3 If the Parties parties dispute whether Product a Batch is conforming or non-conforming to the Product Requirementsconforming, the shipment of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of if non-conformityconforming, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faith. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrectparties.

Product Conformity. Within fifteen (15) business days from the date of shipment of Product With respect to Celator or the receipt of the Released Executed Batch Recordeach Batch, as defined in Product Master Plan, whichever is later, Celator shall determine whether such Product and related documentation conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator shall have the right to revoke acceptance if, within no later than thirty (30) business days of receipt from Nephron’s delivery of the COA and Released Executed Batch Record (provided by RevitaLid) for such Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of delivery. 7.1.1 If (a) any Product conforms RevitaLid shall notify Nephron in writing if the Batch fails to meet the Product Requirements, or (b) Celator . 7.1.1. If RevitaLid fails to notify Baxter in accordance with Nephron within the procedures set forth time period specified in Section 7.1 that any the Product does not conform to the Product Requirements, then Celator RevitaLid shall be deemed to have accepted such the Product and waived its right to revoke acceptance. 7.1.2 7.1.2. If Celator RevitaLid believes any the Product does not conform to the Product Requirements, it shall notify Baxter by telephone including a detailed explanation give written notice to Nephron specifying the manner in which such the Product fails to meet the Product Requirements. Guidelines for resolving any disputed claims regarding conformity of the non-conformity and Product are set forth in Section 7.1.3. 7.1.3. If there is any dispute concerning whether the Product complies with the Product Requirements or whether any such failure is due (in whole or in part) to acts or omissions of RevitaLid after delivery of the Product, the Parties first shall confirm refer such notice in writing via international courier servicematter to the head of Quality Department of each company for amicable settlement. Upon receipt of such notice, Baxter will investigate such alleged non-conformity, and (i) if Baxter agrees such Product is non-conforming, Baxter and Celator will mutually determine a corrective action plan within sixty (60) calendar days after receipt of Celator’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 Celator or Baxter, or (ii) if Baxter disagrees with Celator’s determination In the event that the shipment head of Product is non-conforming, Baxter shall so notify Celator by telephone each Quality Department does not settle such dispute within a ten (10) calendar day period and confirm business days (or such notice in writing by overnight delivery to Celator. 7.1.3 If later time as the Parties dispute may agree in writing) after one party referred the matter to the other company’s Quality Department, a sample of the Product retained by Nephron and a sample of the Product delivered to RevitaLid shall be exchanged between the Parties for a counter-check. If such counter-check does not resolve the dispute, a sample of the Product retained by Nephron and a sample of the Product delivered to RevitaLid shall be submitted to an independent, qualified third party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory shall determine whether the Product is conforming or non-conforming delivered to RevitaLid met the Product Requirements at the time of delivery by Nephron, and such laboratory’s determination shall be final. In the event the Product provided by Nephron to the independent, qualified third party laboratory meets the Product Requirements, RevitaLid shall immediately and without delay pay Nephron the Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or Purchase Price. The non-conformity, and prevailing party shall bear the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faith. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrectconsultant, except as set forth in Section 7.2.2.

Product Conformity. Within the later of forty-five (45) calendar days following the date of Halozyme's receipt of Product samples or fifteen (15) business calendar days from following the date of shipment of Product to Celator or the Halozyme's receipt of the applicable entire Released Executed Batch Record, as defined Record(s) and related documentation in accordance with the Product Master Plan, whichever is later, Celator shall determine whether such Product and related documentation conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator Halozyme shall have the right to revoke acceptance ifdetermine whether Product conforms to cGMP, to all other applicable United States laws and regulations and all applicable foreign laws and regulations, to the applicable Product Specifications, and to the Quality Agreement (collectively the "Product Requirements"). Notwithstanding the foregoing, if Halozyme has conducted at least one test of the applicable Batch and in good faith has requested in writing, within thirty the time period specified in this Section 7.1, additional time to perform additional testing, then such period shall be extended as reasonably necessary for Halozyme, or ▇▇▇▇▇▇ (30) business days of receipt of the Batchif requested by Halozyme), Celator discovers a latent defect or adulteration not reasonably discoverable at time of deliveryto perform such additional testing. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator Halozyme fails to notify Baxter in accordance with ▇▇▇▇▇▇ within the procedures set forth time period specified in Section 7.1 that any Product does not conform to the Product Requirements, then Celator Halozyme shall be deemed to have accepted the such Product and waived its right to revoke acceptance.. *** Confidential material redacted and submitted separately to the Commission 7.1.2 If Celator Halozyme believes any Product does not conform to the Product Requirements, it shall notify Baxter by telephone including a detailed explanation of give written notice to ▇▇▇▇▇▇ specifying the non-conformity and shall confirm such notice manner in writing via international courier service. Upon receipt of such notice, Baxter will investigate such alleged non-conformity, and (i) if Baxter agrees which such Product is non-conforming, Baxter and Celator will mutually determine a corrective action plan within sixty (60) calendar days after receipt of Celator’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 Celator or Baxter, or (ii) if Baxter disagrees with Celator’s determination that fails to meet the shipment Product Requirements. Guidelines for resolving any disputed claims regarding conformity of Product is non-conforming, Baxter shall so notify Celator by telephone within a ten (10) calendar day period and confirm such notice are set forth in writing by overnight delivery to CelatorSection 7.1.3. 7.1.3 If the Parties parties dispute whether any Product is conforming or non-conforming to the Product Requirementsconforming, the samples of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faithparties. The non-prevailing party shall bear the costs of such laboratory or consultant are to be borne by the Party whose determination was incorrectconsultant.

Product Conformity. Within fifteen (15) business days from the later of [CONFIDENTIAL TREATMENT REQUESTED] following the date of shipment CLIENT's receipt of Product to Celator samples or [CONFIDENTIAL TREATMENT REQUESTED] following the date of CLIENT's receipt of the applicable Released Executed Batch Record, as defined Record(s) and related documentation in accordance with the Product Master Plan, whichever is later, Celator shall determine whether such Product and related documentation conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator CLIENT shall have the right to revoke acceptance ifdetermine whether Product conforms to cGMP, to all other applicable United States laws and regulations and all foreign laws and regulations of the countries listed in Exhibit 5 (as amended, supplemented or restated from time to time in accordance with Section 2.2.2), to the applicable Kit Component Specifications and/or Kit Specifications, and to the applicable Project Plan(s) and the Quality Agreement (collectively the "Product Requirements"). Notwithstanding the foregoing, if CLIENT has conducted at least one test of the applicable Batch and in good faith has requested in writing, within thirty the time period specified in Section 7.1, additional time to perform additional testing, then such period shall be extended as reasonably necessary for CLIENT, or ▇▇▇▇▇▇ (30) business days of receipt of the Batchif requested by CLIENT), Celator discovers a latent defect or adulteration not reasonably discoverable at time of deliveryto perform such additional testing. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator CLIENT fails to notify Baxter in accordance with ▇▇▇▇▇▇ within the procedures set forth time period specified in Section 7.1 that any Product does not conform to the Product Product7.1.1 Requirements, then Celator CLIENT shall be deemed to have accepted the such Product and waived its right to revoke acceptance. 7.1.2 If Celator CLIENT believes any Product does not conform to the Product Requirements, it shall notify Baxter by telephone including a detailed explanation of give written notice to ▇▇▇▇▇▇ specifying the non-conformity and shall confirm such notice manner in writing via international courier service. Upon receipt of such notice, Baxter will investigate such alleged non-conformity, and (i) if Baxter agrees which such Product is non-conforming, Baxter and Celator will mutually determine a corrective action plan within sixty (60) calendar days after receipt of Celator’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 Celator or Baxter, or (ii) if Baxter disagrees with Celator’s determination that fails to meet the shipment Product Requirements. Guidelines for resolving any disputed claims regarding conformity of Product is non-conforming, Baxter shall so notify Celator by telephone within a ten (10) calendar day period and confirm such notice are set forth in writing by overnight delivery to CelatorSection 7.1.3. 7.1.3 If the Parties parties dispute whether any Product is conforming or non-conforming to the Product Requirementsconforming, the samples of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faithparties. The non-prevailing party shall bear the costs of such laboratory or consultant are to be borne by the Party whose determination was incorrectconsultant, except as set forth in Section 7.2.3.

Product Conformity. Within fifteen [* * *] after the manufacturing of any Batch pursuant to the Project Plan, ▇▇▇▇▇▇ shall promptly forward to Client, or Client’s designee, samples of such Batch. Within [* * *] from the Receipt (15as defined below) business days of such samples of Product or [* * *] from the date of shipment of Product to Celator or the receipt Receipt of the Released Executed Batch Record, as defined in Product Master Plan, whichever is laterlater (the “Inspection Period”), Celator shall Client will determine whether such the Batch of Product and related documentation conforms was Produced according to the Product SpecificationsRequirements and reject such Batch if such Batch was not Produced in accordance with the Product Requirements (“Non-Conforming”) or accept such Batch if such Batch was Produced in accordance with the Product Requirements. If Client believes a Batch is Non-Conforming, Master Batch Recordit shall notify ▇▇▇▇▇▇ as set forth in Section 7.1.2. For purposes of this Section 7.1, “Receipt” shall occur on the first business day following the date of confirmed transmission if ▇▇▇▇▇▇ sends by facsimile or email, and Baxter SOPs (collectively, on the “Product Requirements”); provided, however, that Celator shall have second business day following the right date of delivery to revoke acceptance if, within thirty (30) business days of receipt of the Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of overnight delivery service if ▇▇▇▇▇▇ sends by overnight delivery. 7.1.1 If Client does not notify ▇▇▇▇▇▇ in writing within the Inspection Period that the Batch of Product is Non-Conforming, then such Batch will be deemed to have been accepted and Client will have waived its right to revoke acceptance (a) any other than for Latent Defects, in which case, the Inspection Period for such Product conforms to shall be [* * *] and the Product Requirements, or (b) Celator fails to notify Baxter in accordance with Parties shall then follow the procedures set forth in Section 7.1 that any Product does not conform to the Product Requirements, then Celator shall be deemed to have accepted the Product and waived its right to revoke acceptance7.1.2). THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 7.1.2 If Celator ▇▇▇▇▇▇ released a Batch of Product and Client believes Product does not conform to the Product Requirementssuch Batch is Non-Conforming, it shall notify Baxter by telephone including will provide to ▇▇▇▇▇▇ a detailed explanation of the non-conformity and within the Inspection Period. Such notice of non-conformity shall confirm such notice be confirmed in writing via international courier serviceovernight delivery to ▇▇▇▇▇▇. Upon receipt of such notice, Baxter ▇▇▇▇▇▇ will investigate such alleged non-conformityconformity and, and (ia) if Baxter ▇▇▇▇▇▇ agrees such Product Batch is nonNon-conformingConforming, Baxter and Celator will mutually determine deliver to Client a corrective action plan within sixty (60) calendar days [* * *] after receipt of CelatorClient’s written notice of non-conformity, or such additional time as is reasonably required and mutually agreed if such investigation or plan requires data from sources other than Celator Client or Baxter▇▇▇▇▇▇ (the “Response Period”), or (iib) if Baxter ▇▇▇▇▇▇ disagrees with Celator’s determination that the shipment Batch of Product is nonNon-conformingConforming, Baxter shall ▇▇▇▇▇▇ will so notify Celator by telephone within a ten (10) calendar day period and confirm such notice Client in writing by overnight delivery and provide to CelatorClient a detailed explanation of the conformity within the Response Period. 7.1.3 If the Parties dispute whether the Batch of Product is conforming or nonNon-conforming to Conforming, samples of the Product Requirements, the Product Batch will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of nonif Non-conformityConforming, shall be binding upon the PartiesParties for purposes of determining financial liability. Notwithstanding the foregoing, Celator may Client cannot release a Batch of Product that Baxter ▇▇▇▇▇▇ has reasonably rejected in good faithrejected. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. Within fifteen (15) business days from the date of shipment of Product to Celator or the receipt of the Released Executed Batch Record, as defined in Product Master Plan, whichever is later, Celator shall determine whether such Product and related documentation conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator shall have the right to revoke acceptance if, within thirty (30) business days of receipt of the Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of delivery. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator fails to notify Baxter in accordance with the procedures set forth in Section 7.1 that any Product does not conform to the Product Requirements, then Celator shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 If Celator believes Product does not conform to the Product Requirements, it shall notify Baxter by telephone including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier service. Upon receipt of such notice, Baxter will investigate such alleged non-conformity, and (i) if Baxter agrees such Product is non-conforming, Baxter and Celator will mutually determine a corrective action plan within sixty (60) calendar days after receipt of Celator’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 Celator or Baxter▇▇▇▇▇▇, or (ii) if Baxter ▇▇▇▇▇▇ disagrees with Celator’s determination that the shipment of Product is non-conforming, Baxter ▇▇▇▇▇▇ shall so notify Celator by telephone within a ten (10) calendar day period and confirm such notice in writing by overnight delivery to Celator. 7.1.3 If the Parties dispute whether Product is conforming or non-conforming to the Product Requirements, the Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter ▇▇▇▇▇▇ has reasonably rejected in good faith. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. Within fifteen (15) business days [****] from the date of shipment of Product to Celator or the receipt of the Released Release Executed Batch Record (if requested by ▇▇▇▇▇▇▇), the Certificate of Analysis and the Certificate of Compliance by ▇▇▇▇▇▇▇ from ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ shall (i) inspect, test and determine whether any Contracted Product conforms to Quality, and (ii) inspect the relevant accompanying documentation (under the Quality Agreement) which (if requested by ▇▇▇▇▇▇▇) may include the Release Executed Batch Record, as defined . ▇▇▇▇▇▇▇ shall notify ▇▇▇▇▇▇▇▇ in writing without undue delay of its acceptance of such Contracted Product Master Plan, whichever is later, Celator shall determine whether such Product and related documentation conforms conforming to the Product Specifications, Master Batch Record, and Baxter SOPs Quality (collectively, the “Product RequirementsAcceptance”); provided, however, that Celator shall have the right to revoke acceptance if, within thirty (30) business days of receipt of the Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of delivery. 7.1.1 8.2.1 If (a) any Product conforms to the Product Requirements, or (b) Celator ▇▇▇▇▇▇▇ fails to notify Baxter in accordance with ▇▇▇▇▇▇▇▇ within the procedures set forth in Section 7.1 applicable time period that any shipment of Contracted Product does not conform to the Product RequirementsQuality (i.e. does have a Defect), then Celator such Contracted Product shall be deemed to have accepted been delivered free from any Defect which is detectable by any test or inspections to be performed by ▇▇▇▇▇▇▇ in accordance with the Product Quality Agreement (“Apparent Defect”) and Acceptance shall be deemed to have occurred on the [****] after the Delivery Date and ▇▇▇▇▇▇▇ shall have waived its right rights (i) to revoke acceptanceAcceptance and (ii) regarding any Apparent Defects. 7.1.2 8.2.2 If Celator ▇▇▇▇▇▇▇ believes any shipment of Contracted Product does not conform to the Product RequirementsQuality (i.e. does have a Defect), it shall notify Baxter ▇▇▇▇▇▇▇▇ by telephone including e-mail and provide a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier serviceconformity. Upon receipt of such notice, Baxter will ▇▇▇▇▇▇▇▇ shall investigate such alleged non-conformity, and (i) if Baxter ▇▇▇▇▇▇▇▇ agrees such Contracted Product is non-conforming, Baxter and Celator will mutually determine deliver to ▇▇▇▇▇▇▇ a corrective action plan within sixty (60) calendar days [****] after receipt of Celator’s ▇▇▇▇▇▇▇’▇ written notice of non-conformity, or such additional time as is reasonably required agreed to by ▇▇▇▇▇▇▇ if such investigation or plan requires data from sources other than Celator ▇▇▇▇▇▇▇ or Baxter▇▇▇▇▇▇▇▇, or (ii) if Baxter ▇▇▇▇▇▇▇▇ disagrees with Celator’s ▇▇▇▇▇▇▇’▇ determination that the shipment of Contracted Product is non-conforming, Baxter ▇▇▇▇▇▇▇▇ shall so notify Celator ▇▇▇▇▇▇▇ by telephone e‑mail within a ten (10) calendar day period and confirm such notice in writing by overnight delivery to Celatorthe [****] period. 7.1.3 8.2.3 If the Parties dispute whether a shipment of Contracted Product is conforming or non-conforming to the Product RequirementsQuality, the shipment of Contracted Product will shall be submitted to a mutually acceptable laboratory the Expert or consultant Expert Panel pursuant to Section 22 for resolution, whose evaluation and the determination by the Expert or Expert Panel of conformity or non-conformitynonconformity to Quality, and the cause thereof of non-conformityif nonconforming to Quality, shall be binding upon the Parties. Notwithstanding The incorrect Party shall bear the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faith. The costs of such laboratory Expert or consultant are Expert Panel, absent manifest error. The fees and expenses of the Expert or Expert Panel incurred in making such determination as well as all additional associated costs shall be paid as follows: 8.2.3.1 In the event the allegedly non-conforming Contracted Product is determined to be conforming to Quality, all such fees and expenses for the Expert or Expert Panel, including freight and disposition costs, shall be paid by ▇▇▇▇▇▇▇. 8.2.3.2 In the event such independent Expert or Expert Panel determines the tested Contracted Product to be non-conforming to Quality and determines further such non-conformance was caused by ▇▇▇▇▇▇▇▇ or ▇▇▇▇▇▇▇▇’▇ suppliers (with the exception of the suppliers identified in Section 4.8.1 (last sentence)) (i) all such fees and expenses for the Expert or Expert Panel, including reimbursement of freight and disposition costs, shall be paid by ▇▇▇▇▇▇▇▇; and (ii) the Parties shall jointly investigate the cause of such failure and shall reasonably cooperate in order to resolve the issue(s) underlying such failure as described in the Quality Agreement. 8.2.3.3 In the event the tested Contracted Product is determined by such independent Expert or Expert Panel to be non-conforming, but such Expert or Expert Panel is not able to determine the cause of such non‑conformance, all such fees and expenses for the Expert or Expert Panel, including freight and disposition costs, shall be borne equally by the Parties. 8.2.3.4 In the event such independent Expert or Expert Panel determines the tested Contracted Product to be non-conforming and determines further that such non-conformance was caused by ▇▇▇▇▇▇▇ or any of ▇▇▇▇▇▇▇’▇ suppliers or contractors, or was otherwise caused after the Delivery Date of the relevant Contracted Product, all such fees and expenses for the Expert or Expert Panel, including freight and disposition costs, shall be borne by the Party whose determination was incorrect▇▇▇▇▇▇▇.

Product Conformity. Within fifteen thirty (1530) business calendar days from the date of shipment of samples of Product to Celator or the receipt of the Released Executed Batch Record, as defined in Product Master Plan, whichever is laterlater (the “Inspection Period”), Celator Client shall determine whether such the Batch of Product and related documentation conforms was Produced according to the Product Specifications, Master Requirements and dispute such Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator shall have the right to revoke acceptance if, within thirty (30) business days of receipt of the Batch, Celator discovers a latent defect or adulteration if such Batch was not reasonably discoverable at time of delivery. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator fails to notify Baxter Produced in accordance with the procedures Product Requirements (“Non-Conforming”) or accept such Batch if such Batch was Produced in accordance with the Product Requirements. If Client believes a Batch is Non-Conforming, it shall notify Ology Bio as set forth in Section 7.1 that any Product 7.1.2. Ology Bioservices, Inc. 8 7.1.1 If Client does not conform to notify Ology Bio in writing within the Inspection Period that the Batch of Product Requirementsis Non-Conforming, then Celator such Batch shall be deemed to have been accepted the Product and Client will have waived its right to revoke acceptance. 7.1.2 If Celator Ology Bio releases a Batch of Product and Client believes Product does not conform such Batch is Non-Conforming, Client shall provide to the Product Requirements, it shall notify Baxter by telephone including Ology Bio a detailed explanation of the non-conformity and within the Inspection Period. Such notice of non-conformity shall confirm such notice be confirmed in writing via international courier serviceovernight delivery to Ology Bio. Upon receipt of such notice, Baxter will Ology Bio shall investigate such alleged non-conformityconformity and, and (ia) if Baxter Ology Bio agrees such Product Batch is nonNon-conformingConforming, Baxter and Celator will mutually determine deliver to Client a corrective action plan within sixty thirty (6030) calendar days after receipt of CelatorClient’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 Celator Client or BaxterOlogy Bio (the “Response Period”), or (iib) if Baxter Ology Bio disagrees with Celator’s determination that the shipment Batch of Product is nonNon-conformingConforming, Baxter shall so notify Celator by telephone within Ology Bio will provide to Client a ten (10) calendar day period and confirm such notice detailed explanation Client in writing by overnight delivery to Celatorwithin the Response Period. 7.1.3 If the Parties dispute whether the Batch of Product is conforming Conforming or nonNon-conforming to the Product RequirementsConforming, the Product Batch will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of nonif Non-conformityConforming, shall be binding upon the PartiesParties for purposes of determining financial liability. Notwithstanding the foregoing, Celator may Client shall not release a Batch of Product that Baxter Ology Bio has reasonably rejected in good faithdeemed non-conforming. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. Within fifteen [* * *] after the manufacturing of any Batch pursuant to the Project Plan, ▇▇▇▇▇▇ shall promptly forward to Client, or Client’s designee, samples of such Batch. Within [* * *] from the Receipt (15as defined below) business days of such samples of Product or [* * *] from the date of shipment of Product to Celator or the receipt Receipt of the Released Executed Batch Record, as defined in Product Master Plan, whichever is laterlater (the “Inspection Period”), Celator shall Client will determine whether such the Batch of Product and related documentation conforms was Produced according to the Product SpecificationsRequirements and reject such Batch if such Batch was not Produced in accordance with the Product Requirements (“Non-Conforming”) or accept such Batch if such Batch was Produced in accordance with the Product Requirements. If Client believes a Batch is Non-Conforming, Master Batch Recordit shall notify ▇▇▇▇▇▇ as set forth in Section 7.1.2. For purposes of this Section 7.1, “Receipt” shall occur on the first business day following the date of confirmed transmission if ▇▇▇▇▇▇ sends by facsimile or email, and Baxter SOPs (collectively, on the “Product Requirements”); provided, however, that Celator shall have second business day following the right date of delivery to revoke acceptance if, within thirty (30) business days of receipt of the Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of overnight delivery service if ▇▇▇▇▇▇ sends by overnight delivery. 7.1.1 If Client does not notify ▇▇▇▇▇▇ in writing within the Inspection Period that the Batch of Product is Non-Conforming, then such Batch will be deemed to have been accepted and Client will have waived its right to revoke acceptance (a) any other than for Latent Defects, in which case, the Inspection Period for such Product conforms to shall be [* * *] and the Product Requirements, or (b) Celator fails to notify Baxter in accordance with Parties shall then follow the procedures set forth in Section 7.1 that any Product does not conform to the Product Requirements, then Celator shall be deemed to have accepted the Product and waived its right to revoke acceptance7.1.2). 7.1.2 If Celator ▇▇▇▇▇▇ released a Batch of Product and Client believes Product does not conform to the Product Requirementssuch Batch is Non-Conforming, it shall notify Baxter by telephone including will provide to ▇▇▇▇▇▇ a detailed explanation of the non-conformity and within the Inspection Period. Such notice of non-conformity shall confirm such notice be confirmed in writing via international courier serviceovernight delivery to ▇▇▇▇▇▇. Upon receipt of such notice, Baxter ▇▇▇▇▇▇ will investigate such alleged non-conformityconformity and, and (ia) if Baxter ▇▇▇▇▇▇ agrees such Product Batch is nonNon-conformingConforming, Baxter and Celator will mutually determine deliver to Client a corrective action plan within sixty (60) calendar days [* * *] after receipt of CelatorClient’s written notice of non-conformity, or such additional time as is reasonably required and mutually agreed if such investigation or plan requires data from sources other than Celator Client or Baxter▇▇▇▇▇▇ (the “Response Period”), or (iib) if Baxter ▇▇▇▇▇▇ disagrees with Celator’s determination that the shipment Batch of Product is nonNon-conformingConforming, Baxter shall ▇▇▇▇▇▇ will so notify Celator by telephone within a ten (10) calendar day period and confirm such notice Client in writing by overnight delivery and provide to CelatorClient a detailed explanation of the conformity within the Response Period. 7.1.3 If the Parties dispute whether the Batch of Product is conforming or nonNon-conforming to Conforming, samples of the Product Requirements, the Product Batch will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of nonif Non-conformityConforming, shall be binding upon the PartiesParties for purposes of determining financial liability. Notwithstanding the foregoing, Celator may Client cannot release a Batch of Product that Baxter ▇▇▇▇▇▇ has reasonably rejected in good faithrejected. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. Within fifteen (15) business days [ * ] from the date of shipment of samples of Product to Celator or the receipt release of the Released Executed Batch Record, as defined in Product Master PlanRecord to Dynavax, whichever is laterlater (the “Inspection Period”), Celator shall Dynavax will determine whether such Batch of Product was Produced in accordance with the Product Requirements and related documentation conforms accept or reject such Batch of Product for non-conformance to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator Dynavax shall have the right to revoke acceptance if, within thirty (30) business days [ * ] of receipt of the Batch, Celator Dynavax discovers a latent defect or adulteration not reasonably discoverable at the time of delivery. 7.1.1 . If (a) any Product conforms to the Product Requirements, or (b) Celator Dynavax fails to notify Baxter in accordance with ▇▇▇▇▇▇ within the procedures set forth in Section 7.1 applicable time periods that any the Batch of Product does not conform to the Product Requirements, then Celator Dynavax shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 . If Celator Dynavax believes Product a Batch does not conform to the Product Requirements, it shall notify Baxter by telephone including ▇▇▇▇▇▇ as set forth in Section 7.1.1. 7.1.1 If ▇▇▇▇▇▇ released a Batch of Product and Dynavax believes such Batch does not conform to the Product Requirements, it will provide to ▇▇▇▇▇▇ a detailed written explanation of the non-conformity and shall confirm such notice in writing via international courier servicewithin the Inspection Period. Upon receipt of such notice, Baxter ▇▇▇▇▇▇ will investigate such alleged non-conformityconformity and, and (ia) if Baxter ▇▇▇▇▇▇ agrees such Batch of Product is non-conforming, Baxter and Celator will mutually determine deliver to Dynavax a corrective action plan within sixty thirty (6030) calendar days after receipt of CelatorDynavax’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 Celator Dynavax or Baxter▇▇▇▇▇▇ (the “Response Period”), or (iib) if Baxter ▇▇▇▇▇▇ disagrees with Celator’s determination that the shipment such Batch of Product is non-conforming, Baxter shall ▇▇▇▇▇▇ will so notify Celator by telephone within a ten (10) calendar day period and confirm such notice Dynavax in writing by overnight delivery to Celatorwithin the Response Period. 7.1.3 7.1.2 If the Parties dispute whether Product is conforming or non-conforming to the Product Requirements, the Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected is non-conforming, the dispute will be handled in good faith. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.accordance with Section 9.1.1

Product Conformity. Within fifteen thirty-five (1535) business days from the date of shipment of Product to Celator or the receipt of the and/or Released Executed Batch Record, as defined in Product Master Plan, to Client, whichever is later, Celator Client shall determine whether such (a) Clinical Product was Produced according to the Product Specifications, Master Batch Records, and related documentation ▇▇▇▇▇▇ SOPs and (b) Commercial Product conforms to the Product Specifications, Master Batch Record, and Baxter ▇▇▇▇▇▇ SOPs (collectively, the “Product Requirements”); , provided, however, that Celator Client shall have the right to revoke acceptance if, within thirty one hundred and twenty (30120) business days of receipt of the Batch, Celator Client discovers a latent defect or adulteration not reasonably discoverable at time of delivery. ▇▇▇▇▇▇ will not ship a Product that ▇▇▇▇▇▇ has rejected. 7.1.1 If (a) any shipment of Product conforms to does not meet the Product Requirements, or (b) Celator Client fails to notify Baxter ▇▇▇▇▇▇ in accordance with writing within the procedures set forth in Section 7.1 applicable time periods that any shipment of Product does not conform to meet the Product RequirementsRequirements due to recognizable defects, then Celator Client shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 If Celator Client believes any shipment of Product does not conform to meet the Product Requirements, it shall notify Baxter ▇▇▇▇▇▇ by telephone electronic message including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier serviceelectronic message to ▇▇▇▇▇▇. Upon receipt of such notice, Baxter ▇▇▇▇▇▇ will investigate such alleged non-conformity, and (i) if Baxter ▇▇▇▇▇▇ agrees such Product is non-conforming, Baxter ▇▇▇▇▇▇ and Celator Client will mutually determine a corrective action plan within sixty forty-five (6045) calendar days after receipt of CelatorClient’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 Celator Client or Baxter▇▇▇▇▇▇, or (ii) if Baxter ▇▇▇▇▇▇ disagrees with CelatorClient’s determination that the shipment of Product is non-conforming, Baxter ▇▇▇▇▇▇ shall so notify Celator Client by telephone electronic message within a ten forty-five (1045) calendar day period and confirm such notice in writing by overnight delivery to CelatorClient. 7.1.3 If the Parties dispute whether a shipment of Product is conforming or non-conforming to the Product Requirementsconforming, the shipment of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may Client cannot release a Batch of Product that Baxter ▇▇▇▇▇▇ has reasonably rejected in good faithrejected. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. 7.1.1 Within fifteen *** (15***) business working days from the date of shipment of Product to Celator or the receipt of after PONIARD receives the Released Executed Batch RecordRecord or CoA and CoC from BAXTER as set forth in the Quality Agreement, as defined in Product Master Plan, whichever is later, Celator PONIARD shall determine whether such Product and related documentation conforms documents conform to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator PONIARD shall have the right to revoke acceptance if, within thirty *** (30***) business days of receipt of the Batch, Celator PONIARD discovers a latent defect or adulteration not reasonably discoverable at time of delivery. 7.1.1 . If (a) any shipment of Product conforms to the Product Requirements, or (b) Celator PONIARD fails to notify Baxter BAXTER in accordance with writing within the procedures applicable time periods set forth in Section 7.1 above that any shipment of Product does not conform to the Product Requirements, then Celator PONIARD shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 If Celator PONIARD believes any shipment of Product does not conform to the Product Requirements, it shall notify Baxter BAXTER by telephone e-mail confirmed by fax or letter including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier serviceconformity. Upon receipt of such notice, Baxter BAXTER will investigate such alleged non-conformity, and (i) if Baxter BAXTER agrees such Product is non-conforming, Baxter BAXTER and Celator PONIARD will mutually determine a corrective action plan within sixty *** (60***) calendar days after receipt of CelatorPONIARD’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 Celator PONIARD or BaxterBAXTER, or (ii) if Baxter BAXTER disagrees with CelatorPONIARD’s determination that the shipment of Product is non-conforming, Baxter BAXTER shall so notify Celator PONIARD by telephone within a ten *** (10***) calendar day period working days and confirm such notice in writing by overnight delivery to Celatordelivery. 7.1.3 If the Parties parties dispute whether a shipment of Product is conforming or non-conforming to the Product Requirementsconforming, the shipment of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faithparties. The costs of such laboratory or consultant are to be borne by the Party party whose determination of conformity or non-conformity was incorrect.

Product Conformity. Within fifteen thirty (1530) business calendar days from the date of shipment of Product to Celator or the receipt of both the Product and the Released Executed Batch RecordRecord to Chiron or to a facility designated by Chiron, as defined in Chiron shall test any shipment of the Product Master Plan, whichever is later, Celator shall to determine whether such Product and related documentation it conforms to the Product Specifications, Master Batch Record, and Baxter SOPs (collectively, the “Product Requirements”); provided, however, that Celator shall have the right to revoke acceptance if, within thirty (30) business days of receipt . If any shipment of the Batch, Celator discovers a latent defect or adulteration not reasonably discoverable at time of delivery. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator fails to notify Baxter in accordance with the procedures set forth in Section 7.1 that any Product does not conform to the Product Requirements, then Celator Chiron shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 . If Celator believes Chiron fails to notify Rhein Biotech and GCVC within the thirty (30) calendar day period that any shipment of the Product does not conform to the Product Requirements, it then Chiron shall be deemed to have accepted the Product and waived its right to revoke acceptance. If Chiron believes any shipment of the Product does not conform to the Product Requirements, Chiron shall notify Baxter by telephone Rhein Biotech and GCVC including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier serviceconformity. Upon receipt of such notice, Baxter Rhein Biotech and GCVC will investigate such alleged non-conformity, nonconformity and (i) if Baxter agrees Rhein Biotech and GCVC agree such Product is non-conforming, Baxter and Celator will mutually determine deliver to Chiron a corrective action plan within sixty thirty (6030) calendar days after receipt of CelatorChiron’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 Celator or Baxter, or (ii) if Baxter disagrees Rhein Biotech and GCVC disagree with CelatorChiron’s determination that the shipment of the Product is non-conforming, Baxter Rhein Biotech and GCVC shall so notify Celator Chiron by telephone within a ten the thirty (1030) calendar day period and confirm such notice in writing by overnight delivery to Celator. 7.1.3 delivery. If the Parties dispute whether a shipment of the Product is conforming or non-conforming to conforming, the Product Requirements, shipment of the Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, conformity shall be binding upon the Parties. Notwithstanding The incorrect Party shall bear the foregoing, Celator may not release a Batch of Product that Baxter has reasonably rejected in good faith. The costs of such laboratory or consultant are consultant. In the event that Rhein Biotech and GCVC agree that the shipment of the Product is non-conforming or the laboratory determines that the shipment of the Product is non-conforming, Rhein Biotech and GCVC shall replace such non-conforming Product within sixty (60) calendar days from receipt of replacement Bulk Chiron Material from Chiron, Chiron shall pay for all Product; provided, however, in the event a shipment of the Product is determined to be borne by non-conforming solely as a result of the Party whose determination was incorrectacts or omissions of Rhein Biotech and GCVC, then Rhein Biotech and GCVC shall (a) reimburse Chiron for its actual cost of the Bulk Chiron Material for the non-conforming shipment of the Product, and (b) either (i) refund the purchase price of the non-conforming Product, to the extent already paid or (ii) replace the non-conforming shipment of the Product at Rhein Biotech and GCVC’s expense but subject to Chiron supplying the replacement Bulk Chiron Material at Chiron’s expense.

Product Conformity. Within fifteen twenty (1520) business calendar days from the date of shipment of samples of Product to Celator or the receipt of the Released Executed Batch Record, as defined in Product Master Plan, whichever is later, Celator shall Client will determine whether such the Batch of Product and related documentation conforms was Produced according to the Product Specifications, Master Requirements and reject such Batch Record, and Baxter SOPs if such Batch was not Produced in accordance with the Product Requirements (collectively, “Non-Conforming”) or accept such Batch if such Batch was Produced in accordance with the “Product Requirements”); provided. If Client rejects a Batch as Non-Conforming. it shall notify Baxter as set forth in Section 7.1.2. Notwithstanding the foregoing, however, that Celator Client shall have the right to revoke acceptance if, within thirty ninety (3090) business days of receipt of the Batch, Celator Client discovers a latent defect or adulteration not reasonably discoverable at time of deliveryB▇▇▇▇▇’▇ release of the Batch of Product. 7.1.1 If (a) any Product conforms to the Product Requirements, or (b) Celator fails to Client does not notify Baxter in accordance with writing within the procedures set forth in Section 7.1 applicable time periods that any the Batch of Product does not conform to the Product Requirementsis Non-Conforming, then Celator shall such Batch will be deemed to have been accepted the Product and Client will have waived its right to revoke acceptance. 7.1.2 If Celator believes Baxter released a Batch of Product does not conform to the Product Requirementsand Client rejects such Batch as Non-Conforming, it shall notify will provide to Baxter by telephone including a detailed explanation of the non-conformity and within the applicable time period. Such notice of non-conformity shall confirm such notice be confirmed in writing via international courier serviceby Client to Baxter in accordance with Article 20. Upon receipt of such notice, Baxter will investigate such alleged non-conformityconformity and, and (ia) if Baxter agrees such Product Batch is nonNon-conformingConforming, Baxter and Celator Client will mutually determine a corrective an action plan within sixty (60) calendar days after receipt of CelatorClient’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 Celator Client or BaxterBaxter (the “Response Period”), or (iib) if Baxter disagrees with Celator’s determination that the shipment Batch of Product is nonNon-conformingConforming, Baxter shall will so notify Celator by telephone within a ten (10) calendar day period and confirm such notice Client in writing by overnight delivery to Celatorwithin the Response Period. 7.1.3 If the Parties dispute whether the Batch of Product is conforming or nonNon-conforming to the Product RequirementsConforming, the Product Batch will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, conformity shall be binding upon the Parties. Notwithstanding For the foregoingavoidance of doubt, Celator may Baxter will not be required to change its quality disposition based on the determination of the third party laboratory or consultant. Client cannot release a Batch of Product that Baxter has reasonably rejected in good faithrejected. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.

Product Conformity. Within fifteen thirty-five (1535) business days from the date of shipment of Product to Celator or the receipt of the and/or Released Executed Batch Record, as defined in Product Master Plan, to Client, whichever is later, Celator Client shall determine whether such (a) Clinical Product was Produced according to the Product Specifications, Master Batch Records, and related documentation B▇▇▇▇▇ SOPs and (b) Commercial Product conforms to the Product Specifications, Master Batch Record, and Baxter B▇▇▇▇▇ SOPs (collectively, the “Product Requirements”); , provided, however, that Celator Client shall have the right to revoke acceptance if, within thirty one hundred and twenty (30120) business days of receipt of the Batch, Celator Client discovers a latent defect or adulteration not reasonably discoverable at time of delivery. B▇▇▇▇▇ will not ship a Product that B▇▇▇▇▇ has rejected. 7.1.1 If (a) any shipment of Product conforms to does not meet the Product Requirements, or (b) Celator Client fails to notify Baxter B▇▇▇▇▇ in accordance with writing within the procedures set forth in Section 7.1 applicable time periods that any shipment of Product does not conform to meet the Product RequirementsRequirements due to recognizable defects, then Celator Client shall be deemed to have accepted the Product and waived its right to revoke acceptance. 7.1.2 If Celator Client believes any shipment of Product does not conform to meet the Product Requirements, it shall notify Baxter B▇▇▇▇▇ by telephone electronic message including a detailed explanation of the non-conformity and shall confirm such notice in writing via international courier serviceelectronic message to B▇▇▇▇▇. Upon receipt of such notice, Baxter B▇▇▇▇▇ will investigate such alleged non-conformity, and (i) if Baxter B▇▇▇▇▇ agrees such Product is non-conforming, Baxter B▇▇▇▇▇ and Celator Client will mutually determine a corrective action plan within sixty forty-five (6045) calendar days after receipt of CelatorClient’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 Celator Client or BaxterB▇▇▇▇▇, or (ii) if Baxter B▇▇▇▇▇ disagrees with CelatorClient’s determination that the shipment of Product is non-conforming, Baxter B▇▇▇▇▇ shall so notify Celator Client by telephone electronic message within a ten forty-five (1045) calendar day period and confirm such notice in writing by overnight delivery to CelatorClient. 7.1.3 If the Parties dispute whether a shipment of Product is conforming or non-conforming to the Product Requirementsconforming, the shipment of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof of non-conformity, shall be binding upon the Parties. Notwithstanding the foregoing, Celator may Client cannot release a Batch of Product that Baxter B▇▇▇▇▇ has reasonably rejected in good faithrejected. The costs of such laboratory or consultant are to be borne by the Party whose determination was incorrect.