Common use of Acceptance/Rejection of Product Clause in Contracts

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected Batches shall be deemed accepted. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] acknowledges and agrees that [***] with respect to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of cGMP Batches, Customer Forty Seven shall inspect such cGMP Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer Forty Seven shall notify Lonza in writing of any rejection of a cGMP Batch based on any claim that it fails to meet Specifications within [***] days of Release, after which time all unrejected cGMP Batches shall be deemed accepted, subject to Forty Seven’s right to reject any cGMP Batch for latent defects set out in this clause 7.3. 1. Forty Seven shall inform Lonza in writing in case of latent defects (i.e. not discovered by routine quality control means), promptly upon discovery of such defects but no later than [*] after delivery of the Product. 7.3.2 In the event that Lonza believes that a cGMP Batch has been incorrectly rejectedrejected by Forty Seven, Lonza must notify Forty Seven in writing within [*] days (such notice, the “Dispute Notice”) and Lonza may require require, that Customer Forty Seven provide to it cGMP Batch samples for testing. Lonza may retain and test the samples of such cGMP Batch. In the event of a discrepancy between CustomerForty Seven’s and Lonza’s test results such that Lonza’s test results fall within relevant determine that the cGMP Batch conforms with the Specifications, or there otherwise exists a dispute between the Parties over whether such cGMP Batch fails to conform to the Specifications or the extent to which such failure is attributable to a given Party, the Parties shall cause use good faith efforts to resolve any such discrepancy or dispute; provided that if such dispute cannot be settled within [*] days from the receipt of the Dispute Notice, then the Parties will submit a sample of the cGMP Batch to an independent laboratory and require the independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent Independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with switch such testing and review shall be borne by the Party against whom the independent Independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed Subject to conform with the Specifications (a “Failed Batch”)clauses 2.2 and 2.3, in the event that it is determined (by the Parties or the independent laboratory) that any cGMP Batch failed to conform with the Specifications (each a “Failed Batch”) and such failure was [***] (“Lonza Responsibility”). If ) then Lonza shall replace such Failed Bath at its sole cost and expense, including bearing the cost of obtaining any Raw Material, Resin or other material required for the manufacture of such replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]Batch. Such replacement shall be made as promptly as practicable, subject to available [*] = Certain confidential information contained in light this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of available the Securities Act of 1933, as amended. manufacturing capacity, capacity after the confirmation of Lonza Responsibility, Responsibility and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] acknowledges and agrees that [***] with respect to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Forty Severn Materials consumed in any Failed Batch which failed to meet Specifications except to the extent set forth in this Clause 7.3.3.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected Batches shall be deemed accepted. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Lonza Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in . In the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] (“Lonza Responsibility”), Lonza agrees to [***]. The compensation is capped at [***]% of the price of that Failed Batch. If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the SpecificationsSpecifications due to Lonza’s Responsibility, then the Steering Committee shall decide in its sole discretion, [***]if Lonza shall either replace such cGMP Batch or refund the amounts paid by Customer for such cGMP Batch. Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Customer acknowledges and agrees that its [***] with respect to a Failed Batch that is a Lonza Responsibility is [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3.

Acceptance/Rejection of Product. 7.3.1 Promptly following Lonza Release of Batchesa Batch, Customer shall inspect such Batches Batch and shall have the right to test such Batches Batch to determine compliance with the Product Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of ReleaseRelease for Delivery, after which time all unrejected Batches shall be deemed accepted. Customer shall inform Lonza in writing in case of concealed or latent defects (i.e. not discovered by routine quality control means), promptly upon discovery of such defects but no later than [***] after delivery of the Product. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or and analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall Reprocess or Rework any Batch, as defined in the Quality Agreement, or, if Reprocessing or Reworking is not possible, replace any Batch that failed fails to conform with the Specifications (a “Failed Batch”). In the event that such failure of the Failed Batch is determined by the Parties or the independent laboratory in accordance with Section 7.3.2 to be attributable to the Manufacturing Process supplied to Lonza by Customer (“AMAG Failed Batch”), then such Reprocessing, Reworking or replacement will be at [***] cost, including the cost of Raw Materials and Necessary Consumables, according to a schedule mutually agreed to by the Parties, which shall in any event be as promptly as practicable. In the event that it is determined (by the Parties or the independent laboratory) laboratory in accordance with Section 7.3.2 that such failure was of the Failed Batch is not attributable to the Manufacturing Process supplied to Lonza by Customer (“Lonza Failed Batch”), then such Reprocessing, Reworking or replacement will be at [***] (“Lonza Responsibility”). If cost, including the cost of Raw Materials and Necessary Consumables, and according to a schedule mutually agreed to by the Parties, which shall in any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall event be made as promptly as practicable, in light of available manufacturing capacity, after . If Lonza is or will be unable to (i) Reprocess or Rework such Lonza Failed Batch and deliver the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. resulting Product within [***] acknowledges of the Delivery Date, or (ii) replace such Lonza Failed Batch and agrees deliver the resulting Product within [***] of the Delivery Date, then in either case Lonza shall instead, at Customer’s discretion, refund the Batch Price of the Lonza Failed Batch to Customer. In the event that [***] or more consecutive Lonza Failed Batches occur during the Term, Customer may, at its discretion, terminate this Agreement. Regardless of the remedy elected by Customer under this Section 7.3.3, for the purpose of calculating whether Customer has purchased the Minimum Quantity in accordance with Section 6.4, a Failed Batch shall be considered a Batch “purchased” on the Commencement Date of such Batch as specified in the Purchase Order. Except for Lonza’s indemnification obligations set forth in Section 11.1, Customer acknowledges and agrees that its sole remedy with respect to a Lonza Failed Batch that is a Lonza Responsibility [***]as set forth in this Section, and in furtherance thereof, [***]. Lonza shall not be responsible for Customer hereby waives all other remedies at law or in equity regarding the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3foregoing claims.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] days of Release, after which time all unrejected Batches shall be deemed accepted. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in ) at no cost to Customer. In the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] (“Lonza Responsibility”), (i) Lonza shall [***] and (ii) Customer shall provide Lonza with the Customer Material for each replacement [***]. Notwithstanding the foregoing, Lonza agrees to compensate Customer for lost Customer Materials (e.g. Antigens) in a Failed Batch. This compensation is capped to [***]. If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]if Lonza shall either replace such cGMP Batch or refund the amounts paid by Customer for such cGMP Batch. Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Customer acknowledges and agrees that [***] with respect to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3.

Acceptance/Rejection of Product. 7.3.1 8.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected Batches shall be deemed accepted. *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. 7.3.2 8.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or and analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any 8.3.3 Any Batch that failed to conform with the Specifications (Specifications, including a batch of extraordinary low yield caused by Lonza’s technical error, shall be a “Failed Batch”), in . In the event that it is determined (agreed by the Parties or determined (by the independent laboratory) that such failure Failed Batch was due to [***] (a “Lonza Responsibility”). If any ) then Lonza shall manufacture a replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made as promptly as practicablepossible, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, Responsibility is agreed or determined and in any case as soon as reasonably possible after confirmation of Lonza ResponsibilityResponsibility is agreed or determined. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or CampaignBatch. [***] Customer acknowledges and agrees that [***] its sole remedy with respect to a Failed Batch that is a Lonza Responsibility [***]is as set forth in this Clause 8.3.3, and in furtherance thereof, [***]Customer hereby waives all other remedies at law or in equity regarding the foregoing claims. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.38.3.3. If Customer receives a refund in respect of the Failed Batch that is a Lonza Responsibility or Customer did not pay for the Failed Batch that was a Lonza Responsibility, Customer shall pay the Batch Price for the replacement Batch and any Raw Materials and Resins used therein. 8.3.4 If any Failed Batch is not a Lonza Responsibility then Lonza shall, if Customer wishes, manufacture a replacement Batch at Customer’s cost and subject to available capacity at the Facility.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] thirty (30) days of Release, after which time all unrejected Batches shall be deemed accepted; provided that (a) Lonza provides timely answers to information requests and resolution of issues arising from Customer’s review of such Batch (and the thirty (30) day period shall be extended to account for Lonza’s failure to provide timely answers to information requests and resolution of such issues); and (b) failure to notify shall not prejudice Customer’s right to reject or revoke acceptance of the Batch if the non-conforming condition causing the Product to fail to meet Specifications could not have been detected by Customer’s inspection undertaken pursuant to this Clause 7.3.1; provided that any such notification shall be provided to Lonza within six (6) months of delivery of the Product; and (c) the warranty provided in Clause 11.1.3 and Lonza’s obligations under Clause 12.1 shall survive acceptance of the Batch by Customer until expiration of the additional 6-month period specified above. In the event that Customer desires to accept a Batch prior to the end of the thirty (30) day period, Customer will provide written notice of such acceptance to Lonza. 7.3.2 Any Batches rejected by Customer are to be returned to Lonza, at Customer’s expense, or held in quarantine and in no circumstances shall the Customer use or destroy the Batches. Customer shall provide Lonza with written notice of rejection of any Batch, which shall specify the manner in which the Batch fails to conform to the warranties set forth in Clause 11.2. 7.3.3 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 7.3.4 Lonza shall replace any Batch (except for an Engineering Batch) that failed to conform with meet the Specifications (a “Failed Batch”), in to the event extent that it is determined (by the Parties or the independent laboratory) that such failure was [***] solely due to Lonza’s material breach of its obligations hereunder, negligence or intentional misconduct (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Customer acknowledges and agrees that [***] its sole remedy with respect to a Failed Batch that is a Lonza Responsibility [***]is as set forth in this Clause 7.3.4, and in furtherance thereof, [***]Customer hereby waives all other remedies at law or in equity regarding the foregoing claims. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.37.3.4. 8 Price and Payment 8.1 Pricing for the Services and/or Batches of Product delivered by Lonza are set out in, and based on the assumptions and information set out in, the applicable Project Plan. Any change in scope of services of the Project Plan shall be subject to an amendment to be signed between Parties. In the event of changes to the Services based on Customer’s request, Customer shall bear all additional costs. Any reduction in the number of Batches shall be subject to the Cancellation fees as set forth in Clause 6 and any reduction in Services other than manufacturing Batches shall be subject to Clause 6.4.4. 8.2 Unless otherwise indicated in writing by Lonza, [ ]*, all Prices and charges are exclusive of value added tax (VAT) and of any other applicable taxes, levies, import, duties and fees of whatever nature imposed by or under the authority of any government or public authority and all such charges applicable to the Services shall be paid by Customer. When sending payment to Lonza, the Customer shall quote the relevant invoice number in its remittance advice. The Parties will cooperate to minimize, to the extent legally permissible, the tax liabilities related to this Agreement. Notwithstanding the foregoing, such cooperation shall not cause any adverse tax consequences to be incurred by either Party that would not have otherwise been incurred under the provisions of this Agreement, including this Clause 8.2. 8.3 Lonza shall issue invoices to Customer for fifty percent (50%) of the Price for Products or Services upon commencement thereof and fifty percent (50%) upon Release of applicable Batches or completion of applicable Services, unless otherwise stated in the Project Plan. Charges for Raw Materials and the Raw Materials Fee for each Batch shall be invoiced upon the Release of each Batch. Charges for Resins shall be invoiced by Lonza upon placement of purchase orders for such Resins by Lonza plus the Raw Materials Fee. All invoices are strictly net and payment must be made within thirty (30) days of date of invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release Delivery of cGMP Batches and Process Validation Batches (but not Pilot Batches or Engineering Batches), Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a cGMP Batch or Process Validation Batch based on any claim that it fails to meet conform to cGMP and the Specifications or was not manufactured in accordance with the Quality Agreement within […***…] days of ReleaseDelivery (the “Rejection Notice”), after which time all unrejected cGMP Batches or Process Validation Batches shall be deemed accepted; provided, however, that in the case of a Batch having a defect that causes a Batch to fail to comply with the Specifications and such defect is not discoverable upon reasonable physical inspection and testing performed pursuant to this Clause 7.3.1 but is discovered at a later time (e.g., in the course or as a result of long-term stability studies), but in any event within […***…] months of Delivery, Customer will have […***…] days from the discovery of such defect to provide a Rejection Notice to Lonza, in which case such Batch shall no longer be deemed accepted, provided always that the stability studies do not indicate that the Product would have degraded or deteriorated in any way within this period, in which case there would be no such right of rejection. Following receipt of a Rejection Notice, the Parties shall use their reasonable endeavours to reach a resolution, subject to Clause 7.3.2. 7.3.2 In the event that Lonza believes that a cGMP Batch or Process Validation Batch has been incorrectly rejected, Lonza may require that Customer provide to it cGMP Batch or Process Validation Batch samples for testing. Lonza may retain and test the samples of such cGMP Batch or Process Validation Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within the relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to the Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in In the event that it is determined (by the Parties or the independent laboratory) that any cGMP Batch or Process Validation Batch failed to conform with the Specifications or was not manufactured in accordance with cGMP and the Quality Agreement (a “Failed Batch”), and such failure was [***] or non-conformity: (a) is primarily and materially attributable to Lonza’s breach of its obligations hereunder or Lonza’s negligence or intentional misconduct; or (b) results from a critical failure at the Facility or in the performance of the Manufacturing Process or the equipment used to manufacture Product which in each case, is primarily and materially attributable to Lonza’s breach of its obligations hereunder or Lonza’s negligence or intentional misconduct (collectively, “Lonza Responsibility”). If , or in the event any replacement cGMP Engineering Batch provided as replacement for a Failed Batch also fails to conform demonstrate the successful transfer of the Manufacturing Process to the Specifications, Facility and such failure was primarily and materially attributable to Lonza’s breach of its obligations hereunder or negligence in following the Manufacturing Process or other written instructions in cGMP documentation (a “Failed Engineering Batch”); then the Steering Committee Lonza shall decide in its sole discretion, [***]. Such replacement shall be made replace such Batch as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibilitypracticable (subject always to Lonza’s contractual commitments to Third Parties). Where possible, Customer shall pay for such replacement Batch and the Raw Materials and Resins used therein (and any money Customer paid towards the Failed Batch or Failed Engineering Batch (including Raw Materials and Resins) shall be manufactured with credited to the next scheduled cGMP cost of the replacement Batch or Campaignand related Raw Materials and Resins used in the replacement Batch). [***] Customer acknowledges and agrees that [***] that, except in the case of Persistent Supply Failure (for which Customer shall have the rights and remedies expressly provided in this Agreement) and Lonza’s indemnity obligations pursuant to Clause 12.1 its sole remedy with respect to a Failed Batch that is a Lonza Responsibility [***], and or a Failed Engineering Batch is as set forth in furtherance thereof, [***]this Clause 7.3.3 (notwithstanding any remedies which would otherwise be available at law or in equity). Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch or Failed Engineering Batch except to the extent set forth in this Clause 7.3.3. 7.3.4 Lonza shall investigate, and cooperate reasonably with Customer in investigating, any Failed Batch or Failed Engineering Batch. Lonza shall keep Customer informed of the status of any investigation and, upon completion of the investigation, shall provide Customer with a final written report describing the cause of the failure and summarizing the results of the investigation.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer Licensee shall notify Lonza in writing Fennec or its designee of any rejection of a Batch based on Product and of the basis under this Agreement for such rejection, including any claim that it fails to meet Specifications testing or inspection results, within [***] of Release, Working Days after which time all unrejected Batches shall be deemed accepted. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples delivery of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant SpecificationsProduct to Licensee, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed to conform with the Specifications (a “Failed Batch”)or, in the event that it is determined (by the Parties or the independent laboratory) that such failure was case of Latent Defects, within [***] Working Days after Licensee having first taken notice of the Latent Defect (in each case, a “Lonza ResponsibilityRejection Notice”). Failure to notify Fennec or to identify the basis under this Agreement for rejection within such period shall constitute acceptance of such Product. Following delivery of a Rejection Notice, the Parties shall conduct good faith discussions with the aim of resolving any dispute as to whether a Product is defective. If the Parties are unable to reach such a resolution, then samples or batch records, as appropriate, from the batch which is in dispute will promptly be submitted for testing and evaluation to an independent Third Party (including a testing laboratory) as shall be agreed to in writing by both Parties acting reasonably. The determination of such Third Party as to whether such Product meets the Specifications will be final and binding. The cost of the testing and evaluation by the Third Party shall be borne by Fennec if the Third Party determines that the Product in question does not meet the Specifications as a result of a cause occurring prior to delivery and by Licensee if the Third Party determines that the Product in question meets the Specifications or do not meet the Specifications as a result of a cause occurring after delivery. If any replacement cGMP Batch provided as replacement for a Failed Batch also fails sampled Product is found by the Third Party or is agreed by Fennec not to conform to the SpecificationsSpecifications as a result of a cause occurring prior to delivery, then the Steering Committee Licensee shall decide in its sole discretion, [***]. Such replacement shall not be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibilityrequired to pay for such Product, and in any case Fennec shall as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, if so requested by Licensee, replace such replacement Batch defective Product at no additional cost to Licensee and have such defective Product destroyed, at Fennec’s expense, in accordance with Applicable Law in the jurisdiction in which destruction occurs. Any such defective Product (whether or not subsequently re-delivered by Fennec) shall be manufactured with deducted from the next scheduled cGMP Batch or Campaign. [***] acknowledges and agrees that [***] with respect applicable Minimum Purchase Quantity required to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3purchased by Licensee under Section 4.5.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected Batches shall be deemed accepted. Customer shall inform Lonza in writing in case of concealed or latent defects (i.e. not discovered by routine quality control means), promptly upon discovery of such defects but no later than [***] after delivery of the Product. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or and analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 For Engineering Batches, Lonza shall, at its own expense, reprocess any Engineering Batch or, if reprocessing is not possible, replace any Engineering Batch that failed to conform with the Specifications (a “Failed Engineering Batch”). Following completion of Engineering Batches, before proceeding to Process Validation Batches, the Parties shall agree, in writing, that the Process is validation ready. Following such agreement to proceed with Process Validation Batches, Lonza shall, at its own expense, reprocess any Batch or, if reprocessing is not possible, replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such reprocessing or replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such any replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Customer acknowledges and agrees that [***] its sole remedy with respect to a Failed Engineering Batch that or a Failed Batch is a Lonza Responsibility [***]as set forth in this Clause 7.3.3, and in furtherance thereof, [***]Customer hereby waives all other remedies at law or in equity regarding the foregoing claims. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch. Customer shall be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Engineering Batch; provided, however that in the event that it is determined (by the Parties or an independent laboratory) that a Failed Engineering Batch except was solely due to Lonza’s material breach of its obligations hereunder, gross negligence or operator error, then Lonza shall be responsible for the extent set forth cost of Raw Materials or Customer Materials consumed in this Clause 7.3.3such Failed Engineering Batch. Lonza shall promptly destroy each Failed Engineering Batch or Failed Batch at its cost and expense, if reprocessing is not possible.

Acceptance/Rejection of Product. 7.3.1 7.1.1 Lonza shall perform its own release of Batches (the “Lonza Release”). Promptly following the Lonza Release of a Batch Lonza shall deliver to Customer the Certificate of Analysis, any other documentation as specified in the Quality Agreement, and such other documentation as is reasonably required and Table of Contents notified in advance by Customer to meet all applicable regulatory requirements of the Governmental Authorities. Customer shall review such Documentation and Lonza shall promptly answer all questions from Customer and perform additional investigations as requested. Customer shall notify Lonza in writing of the final release (“Customer Release”) or rejection of the batch without undue delay. 7.1.2 Promptly following the [***] Date of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications or comply with cGMP upon agreed procedures as agreed in the Quality Agreement, but no later than within [***] ([***]) days of Release[***] Date, after which time all unrejected Batches shall be deemed accepted, except for concealed or latent defects. In case of concealed or latent defects discovered later, such notification to be given in writing promptly upon discovery of such defects but, for concealed or latent defects, no later than [***] after Delivery of the Product. 7.3.2 7.1.3 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or and analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. If the Parties are unable to agree on an independent laboratory, [***] shall appoint such laboratory. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error[***]. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 7.1.4 Lonza shall reprocess free of charge any Batch or, if reprocessing is not possible, replace any Batch that failed to conform with the Specifications or was not manufactured in compliance with cGMP (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to ; in the Specifications, then the Steering Committee shall decide in its sole discretion, event of [***]. Such Provided a Lonza Responsibility is confirmed, such reprocessing or replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibilitycapacity and Raw Materials, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Customer acknowledges and agrees that [***] its sole remedy with respect to a Failed Batch that is a Lonza Responsibility [***]is as set forth in this Clause 7.1.4., and in furtherance thereof, [***]. Lonza shall not be responsible for Customer hereby waives all other remedies at law or in equity regarding the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3foregoing claims.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected Batches shall be deemed accepted. Customer shall inform Lonza in writing in case of concealed or latent defects (i.e. not discovered by routine quality control means), promptly upon discovery of such defects but no later than [***] after initial discovery of the defect and in no event after [***] from Release of the Batch. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the PartiesParties and shall be located in either the United States or the European Union. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 . Lonza may, upon written approval of Customer, reprocess any cGMP Batch or, if reprocessing is not possible or Customer does not consent, Lonza shall replace any cGMP Batch that failed to conform with the Specifications Specifications, where such cGMP Batch was required to conform with the Specification (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made With respect to the loss of Customer Supplied Raw Materials and/or Customer Product Components (as promptly as practicableapplicable) used in the Failed Batch, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such Parties agree that for the replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] ]. Lonza shall exercise best commercial efforts to immediately reprocess or replace the Failed Batch. 7.3.3 Customer acknowledges and agrees that [***] with respect to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3.

Acceptance/Rejection of Product. 7.3.1 7.5.1 Promptly following Release of cGMP Drug Substance Batches or cGMP Drug Product Batches, Customer shall inspect such cGMP Drug Substance Batches or cGMP Drug Product Batch and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a cGMP Drug Substance Batch or cGMP Drug Product Batch based on any claim that it fails to meet Specifications within […***…] days of Release, after which time all unrejected cGMP Drug Substance Batches or cGMP Drug Product Batch shall be deemed accepted, subject to Customer’s right to reject any Batch […***…] for a latent defect, provided that such latent defect was not reasonably detectable within […***…] days of its Release and Customer notifies Lonza of such latent defect within […***…] days after discovering such latent defect. 7.3.2 In the event that 7.5.2 If Lonza believes that a cGMP Drug Substance Batch or cGMP Drug Product Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batchsamples. In the event of If there is a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within the relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause appoint an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the cGMP Drug Substance Batch or cGMP Drug Product Batch that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in the event that 7.5.3 If it is determined (by the Parties or the independent laboratory) that that: (a) a rejected cGMP Drug Substance Batch (where such failure was [***] Batch, subject to Clause 2.5, should have been compliant with cGMP and met the Specifications) failed to conform with the Specifications (such Batch being a “Lonza ResponsibilityFailed Drug Substance Batch”). If any , then to the extent this was a Lonza Responsibility Lonza shall, at Customer’s choice, either: (1) refund Customer the amount paid by Customer in respect of such Failed Drug Substance Batch and associated Raw Materials; or (2) schedule a replacement cGMP Drug Substance Batch provided as replacement for a Failed Batch also fails to conform to be manufactured (the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement timing of which shall be made as promptly as practicable, subject always to available capacity in light the Facility), and Customer shall pay for such replacement Drug Substance Batch and Raw Materials and Resins used therein (and any money it paid towards the Failed Drug Substance Batch shall be credited to the cost of available manufacturing capacitysuch replacement cGMP Drug Substance Batch). (b) a rejected cGMP Drug Product Batch (where such Batch, after subject to Clause 2.5, should have been compliant with cGMP and met the confirmation of Specifications) failed to conform with the Specifications (such Batch being a “Failed Drug Product Batch”), then to the extent this was a Lonza Responsibility, Lonza shall, if Lonza is able to repeat such Failed Drug Product Batch then Lonza shall at Customer’s choice either: (1) refund Customer the amount paid by Customer in respect of such Failed Drug Product Batch and associated Raw Materials; or (2) schedule a replacement cGMP Drug Product Batch to be manufactured (the timing of which shall be as promptly as practicable, subject always to available capacity in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possiblethe Facility), and Customer shall pay for such replacement cGMP Drug Product Batch and Raw Materials and Resins used therein (and any money it paid towards the Failed Drug Product Batch shall be manufactured with credited to the next scheduled cost of such replacement cGMP Drug Product Batch). (c) Nothing in this Clause 7.5.3 shall oblige Lonza to replace any material produced by a Drug Substance Batch that may be required to produce any replacement Drug Product Batch. Clause 7.5.3 shall always be subject to the provisions of Clauses 12.4 and 12.5. 7.5.4 Notwithstanding anything else which may be available to it under law or Campaign. [***] in this Agreement, Customer acknowledges and agrees that [***] its sole remedy with respect to a Failed Drug Substance Batch or Failed Drug Product Batch that is a Lonza Responsibility [***]is as set forth in Clause 7.5.3. Accordingly, and Customer hereby waives all other remedies at law or in furtherance thereof, [***]equity regarding the foregoing claims. Lonza shall not be responsible for the cost of Raw Materials or Materials, Customer Materials and/or starting materials consumed in any Failed Drug Substance Batch or Failed Drug Product Batch except to the extent set forth in this Clause 7.3.37.5.3.

Acceptance/Rejection of Product. 7.3.1 8.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected Batches shall be deemed accepted.. *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. CONFIDENTIAL 7.3.2 8.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or and analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any 8.3.3 Any Batch that failed to conform with the Specifications (Specifications, including a batch of extraordinary low yield caused by Lonza’s technical error, shall be a “Failed Batch”), in . In the event that it is determined (agreed by the Parties or determined (by the independent laboratory) that such failure Failed Batch was due to [***] (a “Lonza Responsibility”). If any ) then Lonza shall manufacture a replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made as promptly as practicablepossible, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, Responsibility is agreed or determined and in any case as soon as reasonably possible after confirmation of Lonza ResponsibilityResponsibility is agreed or determined. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or CampaignBatch. [***] Customer acknowledges and agrees that [***] its sole remedy with respect to a Failed Batch that is a Lonza Responsibility [***]is as set forth in this Clause 8.3.3, and in furtherance thereof, [***]Customer hereby waives all other remedies at law or in equity regarding the foregoing claims. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.38.3.3. If Customer receives a refund in respect of the Failed Batch that is a Lonza Responsibility or Customer did not pay for the Failed Batch that was a Lonza Responsibility, Customer shall pay the Batch Price for the replacement Batch and any Raw Materials and Resins used therein. 8.3.4 If any Failed Batch is not a Lonza Responsibility then Lonza shall, if Customer wishes, manufacture a replacement Batch at Customer’s cost and subject to available capacity at the Facility.

Acceptance/Rejection of Product. 7.3.1 8.3.1 Within […***…] ([…***…]) days after Customer’s receipt of all Batch Documentation for a Batch, or such other period as may be specified in the Quality Agreement, Customer shall determine by review of such Batch Documentation whether or not such Batch conforms to the Product Warranty. Promptly following Release receipt of Batcheseach Batch, Customer shall inspect such Batches and Batch. Customer shall have the right to test such Batches reject any Batch that fails to determine compliance with conform to the SpecificationsProduct Warranty. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails of non-conformity to meet Specifications the Product Warranty within […***…] ([…***…]) days of ReleaseCustomer’s receipt of the Batch, after which time all unrejected Batches such Batch shall be deemed accepted. Customer shall have the right to revoke its acceptance and reject a Batch if within […***…] ([…***…]) months following Release of such Batch, Customer discovers a latent defect in such Batch which Customer could not have reasonably discovered upon inspection of such Batch and the related Batch Documentation, and Customer provides written notice thereof to Lonza within […***…] ([…***…]) business days of discovery thereof. 7.3.2 8.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of (a) a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or (b) there exists a dispute between the Parties over the extent to which such failure is attributable to a given PartyParty (including, without limitation, any such dispute over whether such failure is a Lonza Responsibility) that the Parties are unable to resolve within […***…] days of delivery by a Party to the other Party of written notice of the existence of such dispute, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory and analytical procedures shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest errorbinding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 8.3.3 Lonza shall replace any cGMP Batch that failed does not conform to conform with the Specifications Product Warranty (a “Failed cGMP Batch”), in ) with a cGMP Batch conforming to the event that it Product Warranty. If a Failed cGMP Batch is determined (by the Parties or the independent laboratory) that such failure was [***] (“a Lonza Responsibility”, Lonza shall replace such Batch at no additional cost to Customer (except for the cost of Customer Materials). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Customer acknowledges and agrees that [***] that, except in the case of Persistent Supply Failure (for which Customer shall have the rights and remedies expressly provided in this Agreement), Customer’s sole remedy with respect to a Failed cGMP Batch that is a Lonza Responsibility [***], and as set forth in furtherance thereof, [***]this Clause 8.3.3. Lonza shall not be responsible for the cost of Raw Materials or (other than Customer Materials Materials) consumed in any Failed cGMP Batch except for which Lonza Responsibility has been established, but not otherwise. 8.3.4 Notwithstanding anything else in this Agreement, if the sole reason that any Failed cGMP Batch failed to conform to the extent set forth Product Warranty was the failure of the Customer Materials provided by Customer for use in this the manufacture of such Batch to conform to the applicable specifications for such materials, then, provided that Lonza performed quality testing and release on such Customer Materials in accordance with the Quality Agreement prior to their use, Lonza shall have no liability or responsibility for such Failed cGMP Batch under Clause 7.3.38.3.3.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of cGMP Batches, Customer Forty Seven shall inspect such cGMP Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer Forty Seven shall notify Lonza in writing of any rejection of a cGMP Batch based on any claim that it fails to meet Specifications within [***] days of Release, after which time all unrejected cGMP Batches shall be deemed accepted, subject to Forty Seven’s right to reject any cGMP Batch for latent defects set out in this clause 7.3. 1. Forty Seven shall inform Lonza in writing in case of latent defects (i.e. not discovered by routine quality control means), promptly upon discovery of such defects but no later than [*] after delivery of the Product. 7.3.2 In ln the event that Lonza believes that a cGMP Batch has been incorrectly rejectedrejected by Forty Seven, Lonza must notify Forty Seven in writing within [*] days (such notice, the “Dispute Notice”) and Lonza may require that Customer Forty Seven provide to it cGMP Batch samples for testing. Lonza may retain and test the samples of such cGMP Batch. In ln the event of a discrepancy between CustomerForty Seven’s and Lonza’s test results such that Lonza’s test results fall within relevant determine that the cGMP Batch conforms with the Specifications, or there otherwise exists a dispute between the Parties over whether such cGMP Batch fails to conform to the Specifications or the extent to which such failure is attributable to a given Party, the Parties shall cause use good faith efforts to resolve any such discrepancy or dispute; provided that if such dispute cannot be settled within [*] days from the receipt of the Dispute Notice, then the Parties will submit a sample of the cGMP Batch to an independent laboratory and require the independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed Subject to conform with the Specifications (a “Failed Batch”)clause 2.2, in the event that it is determined (by the Parties or the independent laboratory) that any cGMP Batch failed to conform with the Specifications (each a “Failed Batch”) and such failure was [***] (“Lonza Responsibility”)) then Lonza shall replace such Failed Batch at its sole cost and expense, including bearing the cost of obtaining any Raw Material, Resin or [*] = 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 406 of the Securities Act of 1933, as amended. If any other material required for the manufacture of such replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]Batch. Such replacement shall be made as promptly as practicable, in light of subject to available manufacturing capacity, capacity after the confirmation of Lonza Responsibility, Responsibility and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] acknowledges and agrees that [***] with respect to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Forty Seven Materials consumed in any Failed Batch which failed to meet Specifications except to the extent set forth in this Clause 7.3.3.

Acceptance/Rejection of Product. 7.3.1 Promptly following 6.1 Not later than […***…] after AMYLIN’s receipt of all LONZA Batch Release of BatchesDocuments, Customer AMYLIN shall inspect such Batches and shall have examine the right to test such Batches to determine LONZA Batch Release Documents for the Product’s compliance with the SpecificationsProduct Specifications and other warranties set forth in Section 8. Customer Without AMYLIN’s written notice within such period, it is deemed that AMYLIN accepts the Product. If AMYLIN believes that any such shipment does not comply with the Product Specifications or other warranties, or is otherwise deficient, AMYLIN shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within promptly, but not later than […***…] after receipt of Releaseall LONZA Batch Release Documents, after which time all unrejected Batches shall be deemed accepted. 7.3.2 In notify LONZA. AMYLIN and LONZA will work together in good faith to resolve any deviations from any manufacturing processes then in effect and to issue closed deviation reports for the event Product. LONZA will evaluate process issues and other reasons for the deviations. Notwithstanding anything to the contrary set forth herein, AMYLIN may reject any shipment of Product (or part thereof) that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide does not conform to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails Specifications or other warranties in Section 8 (any Product failing to conform to Specificationscomply with the foregoing a “Defective Product”). Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. Notwithstanding the foregoing, if there is subsequently found to be final a Hidden Defect in any shipment of Product, AMYLIN shall promptly notify LONZA in writing and binding save AMYLIN and LONZA shall enter into discussions in good faith as to the handling and disposal of the defective shipment, having due regard to where responsibility for manifest error. Unless otherwise agreed to by such defect lies, with the Parties in writing, the costs associated with such testing and review understanding that LONZA shall be borne by the Party against whom the independent laboratory rulesresponsible with respect to matters existing prior to delivery of Product to AMYLIN. 7.3.3 Lonza 6.2 LONZA shall replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made notify AMYLIN as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibilityreasonably possible, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. event within […***…] acknowledges whether it accepts AMYLIN’s basis for any rejection or in good faith disagrees with AMYLIN’s determination that certain Product does not meet the Product Specifications. If no such notice of dispute is received from LONZA, LONZA shall be deemed to have agreed that the rejection is necessary and agrees that [***] with respect justified. If there is a dispute as to the reasons for rejection of the Product, such Product shall be submitted to a Failed Batch that is a Lonza Responsibility [***], mutually acceptable third party laboratory. Such third party shall determine whether such Product meets the Product Specifications and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent other warranties set forth in Section 8, and the Parties agree that such third party’s determination shall be final and determinative. The party against whom the third party tester rules shall bear all costs of the third party testing. Whether or not LONZA accepts AMYLIN’s basis for rejection, promptly on receipt of a notice of rejection of Product, LONZA shall use commercially reasonable best efforts to replace such rejected Product, at its cost. If the third party tester rules that the lot meets Product Specifications and the other warranties in Section 8, AMYLIN shall purchase that lot at the agreed-upon price, irrespective of whether LONZA has already replaced it. All replacement Product shall be invoiced as well and AMYLIN is to pay for such product as otherwise provided under the terms of this Clause 7.3.3Agreement. Upon acceptance by LONZA of AMYLIN’s rejection of Product or determination by the third party tester that the Product does not meet the Production Specifications and other warranties in Section 8, AMYLIN shall promptly return said Product or quality control sample to LONZA, at LONZA’s cost based on LONZA’s instruction.

Acceptance/Rejection of Product. 7.3.1 Promptly 8.3.1 [*] following the Release of Batchesa cGMP Batch, Customer shall may inspect such Batches cGMP Batch and shall have the right to independently test or have tested such Batches cGMP Batch to determine compliance that the cGMP Batch was manufactured in accordance with cGMP and that it meets the Specifications. Customer shall notify Lonza in writing of any rejection of a cGMP Batch based on any claim that it was not manufactured in accordance with cGMP or fails to meet the Specifications within [***] of Releasethe later of Release or Customer’s receipt of all required documentation for such cGMP Batch, after which time all unrejected Batches time, in either case, any un-rejected cGMP Batch shall be deemed accepted, subject to Customer’s right to reject any Batch at a later time for latent defect, provided that such latent defect was not reasonably detectable and the Customer notifies Lonza [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. of such latent defect within [*] after its discovery, provided that such latent defect is discovered within [*] of the date of Release. 7.3.2 8.3.2 In the event that Lonza believes that a cGMP Batch has been incorrectly rejected, Lonza may require that Customer provide to it cGMP Batch samples for testing. Lonza may retain and test the samples of such cGMP Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 8.3.3 Lonza shall replace any cGMP Batch that failed to conform was not manufactured in accordance with cGMP or does not meet the Specifications [*] (a “Failed cGMP Batch”), in the event that it is determined (by the Parties or the independent laboratory) that . Any such failure was [***] (Failed cGMP Batch shall be deemed to be a “Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. .” Such replacement shall be made as promptly as practicable, in light of available manufacturing capacitycapacity at the Visp Facility or the Porrino Facility as applicable (with the decision as to which facility to use being at Lonza’s discretion), after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with as part of the next scheduled cGMP Batch or Campaign. [***] acknowledges and agrees that [**]. [*] with respect to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed cGMP Batch except to the extent for which Lonza Responsibility has been established as set forth in this Clause 7.3.38.3.3, [*]. If Customer received a refund for the Failed cGMP Batch (including a refund for the applicable Raw Materials Fee) or did not pay in full for the Failed cGMP Batch (including the applicable Raw Materials Fee), then it shall pay for the replacement cGMP Batch in full together with the Raw Materials Fee for such replacement Batch. If Customer wishes to use the Failed Batch for laboratory use (not for in vivo purposes) then the Parties shall discuss and agree an appropriate sum for which Customer shall pay for such Failed Batch, this shall not reduce the obligation on Customer to pay for any replacement Batches. For the avoidance of doubt, this Clause 8.3.3 shall apply to failure to achieve Specification.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] days of Release, after which time all unrejected Batches shall be deemed accepted. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or and analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall reprocess any Batch or, if reprocessing is not possible, replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] solely due to Lonza’s material breach of its obligations hereunder, negligence or intentional misconduct (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails , without additional expense to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]Customer. Such reprocessing or replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such any replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Customer acknowledges and agrees that [***] its sole remedy with respect to a Failed Batch that is a Lonza Responsibility [***]is as set forth in this Clause 7.3.3, and in furtherance thereof, [***]Customer hereby waives all other remedies at law or in equity regarding the foregoing claims. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except in the instance of Lonza Responsibility, herein. Lonza shall have no liability with respect to, and Customer shall be required to pay for, any Failed Batch that is not determined to be a Lonza Responsibility. 8Price and Payment 8.1 Pricing for the Services provided by Lonza are set out in the applicable Project Plan. In the event of changes to the extent set forth Services based on Customer’s request, Customer shall bear all additional costs. 8.2 Unless otherwise indicated in this Clause 7.3.3writing by Lonza, all Prices and charges are exclusive of value added tax (VAT) and of any other applicable taxes, levies, import, duties and fees of whatever nature imposed by or under the authority of any government or public authority and all such charges applicable to the Services shall be paid by Customer. 8.3 Lonza shall issue invoices to Customer as follows: (a) upon commencement of Services, [***] of the Price for such Services, [***]; and (b) upon completion of the Services, the remaining amount. All invoices are strictly net and payment must be made within [***] days of date of invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] days of Release, after which time all unrejected Batches shall be deemed accepted. 7.3.2 In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or and analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall reprocess any Batch or, if reprocessing is not possible, replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] solely due to Lonza’s material breach of its obligations hereunder, negligence or intentional misconduct (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails , without additional expense to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]Customer. Such reprocessing or replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such any replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Customer acknowledges and agrees that [***] its sole remedy with respect to a Failed Batch that is a Lonza Responsibility [***]is as set forth in this Clause 7.3.3, and in furtherance thereof, [***]Customer hereby waives all other remedies at law or in equity regarding the foregoing claims. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except in the instance of Lonza Responsibility, herein. Lonza shall have no liability with respect to, and Customer shall be required to the extent set forth in this Clause 7.3.3pay for, any Failed Batch that is not determined to be a Lonza Responsibility.

Acceptance/Rejection of Product. 7.3.1 Promptly following Release of cGMP Batches, Customer Forty Seven shall inspect such cGMP Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer Forty Seven shall notify Lonza in writing of any rejection of a cGMP Batch based on any claim that it fails to meet Specifications within [***] days of Release, after which time all unrejected cGMP Batches shall be deemed accepted, subject to Forty Seven’s right to reject any cGMP Batch for latent defects set out in this clause 7.3. 1. Forty Seven shall inform Lonza in writing in case of latent defects (i.e. not discovered by routine quality control means), promptly upon discovery of such defects but no later than [*] after delivery of the Product. 7.3.2 In ln the event that Lonza believes that a cGMP Batch has been incorrectly rejectedrejected by Forty Seven, Lonza must notify Forty Seven in writing within [*] days (such notice, the “Dispute Notice”) and Lonza may require that Customer Forty Seven provide to it cGMP Batch samples for testing. Lonza may retain and test the samples of such cGMP Batch. In ln the event of a discrepancy between CustomerForty Seven’s and Lonza’s test results such that Lonza’s test results fall within relevant determine that the cGMP Batch conforms with the Specifications, or there otherwise exists a dispute between the Parties over whether such cGMP Batch fails to conform to the Specifications or the extent to which such failure is attributable to a given Party, the Parties shall cause use good faith efforts to resolve any such discrepancy or dispute; provided that if such dispute cannot be settled within [*] days from the receipt of the Dispute Notice, then the Parties will submit a sample of the cGMP Batch to an independent laboratory and require the independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 Lonza shall replace any Batch that failed Subject to conform with the Specifications (a “Failed Batch”)clause 2.2, in the event that it is determined (by the Parties or the independent laboratory) that any cGMP Batch failed to conform with the Specifications (each a “Failed Batch”) and such failure was [***] (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a ) then Lonza shall replace such Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in at its sole discretioncost and expense, [***]. Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] acknowledges and agrees that [***] with respect to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for including bearing the cost of obtaining any Raw Materials Material, Resin or Customer Materials consumed in any Failed Batch except to the extent set forth [*] = Certain confidential information contained in this Clause 7.3.3document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Acceptance/Rejection of Product. 7.3.1 7.4.1 With respect to [*], Lonza shall deliver to Radius the [*]. With respect to [*] or [*], Lonza shall deliver the [*] to Radius in accordance with the provisions of the applicable Purchase Order. 7.4.2 Promptly following Release of Batches, Customer shall inspect such Batches and Radius shall have the right to inspect such Batches and/or to test such Batches to determine compliance with the Specifications. Customer Radius shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications [*] within [***] of Release, after which time all unrejected Batches shall be deemed accepted. 7.3.2 7.4.3 In the event that Lonza believes that a Batch has been incorrectly rejectedrejected by Radius, Lonza may require that Customer Radius provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s Radius’ and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or and analyses on samples of the Product that allegedly fails to conform to SpecificationsSpecifications or cGMP. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.3.3 7.4.4 Lonza shall [*] reprocess any Batch or, if reprocessing is not possible, replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was solely due to Lonza’s material breach of its obligations hereunder, negligence or intentional misconduct. Reprocessing or replacement [***] (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity. [*] and, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where where possible, such [*] any replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] Radius acknowledges and agrees that [***] its sole remedy with respect to a Failed Batch that is a Lonza Responsibility [***]as set forth in this Clause 7.4.4, and in furtherance thereof, [***]Radius hereby waives all other remedies at law or in equity regarding the foregoing claims. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3[*].