Common use of ACCEPTANCE AND REJECTION Clause in Contracts

ACCEPTANCE AND REJECTION. Purchaser shall have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components.

ACCEPTANCE AND REJECTION. Purchaser Jubilant shall have be entitled to reject any shipment of Products that fails to conform to the right Product Specifications or Packaging Specifications at the time of delivery to test at its expenseJubilant. Jubilant shall notify Cadista of such rejection within thirty (30) days after delivery of such Products shipment to Jubilant, using testing procedures agreed upon by the Parties and shall set forth in such notification the specifications basis under this Agreement for such rejection, including any testing or inspection results, provided, however, that in the applicable Componentevent any such non-conformity is latent or was not obvious and could not be readily discovered from a physical inspection of the Products shipment, Jubilant may give written notice to Cadista of its rejection of such shipment within thirty (30) days after Jubilant's discovery of such non-conformance. Failure to so notify Cadista, or failure to identify the basis under this Agreement for rejection of any Product, shall constitute acceptance of such Product, except to the extent the Product fails to conform to the Product Specifications or Packaging Specifications as the case may be. After such failure to notify, Jubilant shall be obligated to make payment for such Product in accordance with pricing provisions of this Agreement. If the parties disagree as to whether any Product meets the Product Specifications or Packaging Specifications and the parties are unable to negotiate a portion commercially reasonable resolution, then samples and/or batch records, as appropriate, from the disputed shipment shall promptly be submitted for testing and evaluation to an independent Third Party as shall be agreed to in writing by both parties. The determination of each shipment of Components such Third Party as to confirm that such whether the disputed Product shipment meets the applicable Product Specifications or Packaging Specifications shall be final and binding. The cost of the testing and evaluation by the independent third party shall be borne by the party whose position is found to be erroneous. If, pursuant to this Section 3.2, any Products are found not to conform to the Product Specifications or Packaging Specifications, as a result of a cause occurring prior to placement thereof with the carrier (and not arising as a result of the Materials being defective or failing to meet their respective specifications. Where it is required by local regulations), further testing on importation at Cadista’s option, Jubilant shall either (i) deliver such non-conforming Products to Cadista or (ii) destroy such non-conforming Products in accordance with applicable laws, rules and regulations. Cadista shall reimburse Jubilant for all reasonable costs and expenses in connection such delivery or destruction, and, at Cadista’s option and as Jubilant’s exclusive remedy, Cadista shall either: (i) credit Jubilant for the applicable specifications shall be carried out amount paid or payable by Purchaser. If Purchaser rejects in whole or in part any nonconforming Jubilant to Cadista for such rejected Product shipment of Components, Purchaser shall immediately provide Supplier written notice (and reimburse Jubilant for the Material of such rejection. If Supplier agrees rejected batch at Jubilant’s cost for such Materials), or (ii) replace such rejected Product shipment (with Purchaser's determination that a Cadista paying Jubilant for all Materials or such replacement shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts in an amount equal to replace the nonconforming ComponentsJubilant’s cost), at no additional cost to Purchaser. If Supplier Jubilant, as promptly as reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specificationspracticable, Supplier shall use Reasonable Efforts to replace but in no event later than forty-five (45) days from receipt of notice of non-conformity of such shipment from Jubilant. Jubilant shall notify Cadista in writing of Components any claim relating to Purchaser, at Purchaser's expensequantitative deficiencies in any shipment of Product that Jubilant considers to have been caused prior to shipment hereunder within thirty (30) days following receipt of any such shipment. If Supplier disagrees with Purchaser's determination that the rejected shipment did Any claim for a quantitative deficiency which is not meet the applicable specifications, a sample of the rejected shipment made within such thirty (30) days shall be submitted deemed to an independent, qualified Third Party laboratory that is mutually acceptable have been waived by Jubilant and selected by the Parties promptly in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination Jubilant shall be final and determinative obligated to make payment for purposes such Product in accordance with Section 5 of this Agreement. The Party against whom In the laboratory rules event Jubilant determines there is a quantitative deficiency from the applicable shipping documentation, the parties shall bear all costs investigate such deficiency and, if the parties agree that such deficiency occurred prior to shipment, Cadista shall, at Jubilant’s option and as Jubilant’s exclusive remedy for such quantitative deficiency, (a) credit Jubilant for the amount paid by Jubilant to Cadista in excess of the laboratory testing. If aggregate price for actual quantities shipped; or (b) subject to Cadista having Product on hand at the laboratory rules that time of request by Jubilant, rectify any such deficiency by promptly shipping the shipment appropriate quantities of Components failed any relevant Product to meet Jubilant, but in no event later than fifteen (15) calendar days following the applicable specificationsoccurrence of such a deficiency, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment in which case Jubilant shall be reimbursed obligated to Purchaser (provided Purchaser paid pay for any such shipment) or Components meeting the applicable specifications shall be shipped quantities pursuant to Purchaser by Supplier. If the laboratory rules the rejected shipment Section 5 of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Componentsthis Agreement.

ACCEPTANCE AND REJECTION. Purchaser Within [***] days following receipt of each delivery of Device supplied under the Supply Agreement, TRANSCEPT or its designee may conduct an inspection of the Device and may reject such quantities of the Device on the grounds that such quantities (i) fail to conform with the applicable shipping requirements as specified under the applicable purchase order placed by TRANSCEPT or its designee in accordance with the Supply Agreement or (ii) fail to conform to any product warranty for the Device provided under the Supply Agreement (“Non-Conforming Devices”). TRANSCEPT shall have notify SNBL in writing of any Non-Conforming Devices within such [***] day period following receipt of each delivery of Device supplied under the right to test Supply Agreement or, if such nonconformity is not evident upon reasonable physical inspection, within [***] days after discovery of such nonconformity. To the extent such Devices constitute Non-Conforming Devices, SNBL shall promptly replace, at its expense, using testing procedures agreed upon by each such Non-Conforming Device with a Device conforming to the Parties and set forth in the specifications product warranties for the applicable ComponentDevice provided under the Supply Agreement. Upon request from SNBL, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation TRANSCEPT shall return any Non-Conforming Device in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, SNBL’s instructions at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's SNBL’s expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specificationsParties disagree as to whether any quantities of Devices are Non-Conforming Devices, TRANSCEPT shall submit a sample of the rejected relevant shipment shall be submitted of Non-Conforming Devices to an independent, qualified Third Party independent testing laboratory that is mutually acceptable and of recognized repute selected by TRANSCEPT and approved by SNBL, such approval not to be unreasonably withheld, delayed or conditioned, for analysis of whether such Device constitutes a Non-Conforming Device. The costs associated with such analysis by such independent testing laboratory will be paid by the Parties promptly in good faith. Such laboratory shall determine Party whose assessment of whether the rejected Components (as applicable) meet Device constituted a non-Conforming Device was mistaken. The determination by the applicable specificationsindependent testing laboratory, and such laboratory's determination shall unless clearly erroneous, will be final and determinative for purposes binding. Recalls: TRANSCEPT shall have the sole responsibility for, and sole control over, initiating and managing any recall or withdrawal of this Agreementany Product, provided that TRANSCEPT shall consult with SNBL and adopt its reasonable comments and suggestions with respect to any recall or withdrawal of Product to the extent resulting from the Device component of Product. The Party against whom the laboratory rules At TRANSCEPT’s request, SNBL shall bear all costs of the laboratory testingcooperate and provide assistance in connection with any such recall or withdrawal. If the laboratory rules that the shipment of Components failed to meet the applicable specificationsAny such recall or withdrawal, at Purchaser's choiceincluding any assistance provided by SNBL, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and TRANSCEPT sole expense, be returned except to Supplier the extent that any such recall or destroyed by Purchaser. If Supplier has acknowledged in writing that it withdrawal is unable to produce conforming Components, a result of any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy breach of replacement Product warranties for Device or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing SNBL’s negligence or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Componentsintentional misconduct.

ACCEPTANCE AND REJECTION. Purchaser (a) Client may reject any Product supplied hereunder that does not conform with the Specifications or with cGMPs. Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. (b) Client shall have [***] from the right date of receipt of the Product and all associated quality control samples and documentation (inclusive of the Certificate of Analysis) to test at its expenseinspect such Product, using testing review the Certificate of Analysis and other documents {M1463853.1 } and/or perform or have performed any or all of the quality control procedures agreed upon by the Parties and set forth outlined in the specifications for relevant Specifications or the applicable ComponentQuality Agreement to determine if the Product conforms to the Specifications. In order to reject Product, a portion Client must give written notice to CoreRx of each shipment such rejection within [***] after receipt of Components to confirm that such shipment meets Product and the applicable specifications. Where it associated quality control samples and documentation, and if no such notice of rejection is required by local regulationsreceived, further testing on importation in accordance with the applicable specifications Client shall be carried out deemed to have accepted such delivery of Product within [***] of delivery thereof; provided, however, that in the event a Latent Defect is discovered by Purchaser. If Purchaser rejects Client after such [***] inspection period, Client shall promptly, and in whole or in part any nonconforming shipment no event more than [***] after discovery of Componentssuch Latent Defect, Purchaser shall immediately provide Supplier written notice to CoreRx rejecting such Product as a result of such discovered Latent Defect. (c) After notice of rejection is given, Client shall cooperate with CoreRx in determining whether rejection is necessary or justified. CoreRx will evaluate process issues and other reasons for such non-compliance. CoreRx shall notify Client as promptly as reasonably possible whether it accepts Client’s basis for any rejection. If Supplier agrees CoreRx in good faith disagrees with Purchaser's Client’s determination that a shipment of Components certain Product does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specificationsSpecifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment Product shall be submitted to an independent, qualified Third Party laboratory that is a mutually acceptable and selected by the Parties promptly in good faiththird party laboratory. Such third party laboratory shall determine whether such Product meets the rejected Components (as applicable) meet the applicable specificationsSpecifications, and the parties agree that such laboratory's ’s determination shall be final and determinative for purposes of this Agreementdeterminative. The Party party against whom the laboratory third party tester rules shall bear all costs of the laboratory third party testing. Whether or not CoreRx accepts Client’s basis for rejection, promptly on receipt of a notice of rejection of Product, CoreRx shall replace such rejected Product, at its cost, within [***], subject to Section 6.3(e) of this Agreement. If the laboratory third party tester rules that such Product meets Specifications, Client shall purchase that batch at the shipment agreed-upon price, irrespective of Components failed whether CoreRx has already replaced it. (d) Client may not destroy any rejected Product until it receives written notification from CoreRx that CoreRx does not dispute that such Product fails to meet Specifications and that CoreRx does not request return of such Product. Upon authorization from CoreRx to do so, Client shall destroy such rejected Product promptly at CoreRx’s cost and provide CoreRx with certification of such destruction. Client shall, upon receipt of CoreRx’s request for return of rejected Product, promptly return such Product to CoreRx, at CoreRx’s cost. (e) Client acknowledges that, where CoreRx is required to manufacture and deliver a Product for use in clinical trials where the manufacturing process has not been validated yet, failing to meet the applicable specificationsmanufacturing Specifications shall not constitute a failure to deliver, provided that CoreRx has complied with the processes and procedures established in the batch record for the manufacture of the Product at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment date of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Componentsmanufacture.

ACCEPTANCE AND REJECTION. Purchaser (a) Cardiome shall have the right to test at its expense, using testing procedures agreed inspect all shipments of Supplied Items promptly upon by the Parties receipt and set forth in the specifications for the applicable Component, a portion of each may reject any shipment of Components Supplied Items or portion thereof that fails to confirm that such shipment meets conform to the applicable specificationsProduct Warranty (“Defective Product”). Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part In order to reject any nonconforming shipment of ComponentsSupplied Items or portion thereof, Purchaser shall immediately provide Supplier Cardiome must give written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable rejection to SteadyMed within [*] = 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. Efforts to replace the nonconforming Components, after receipt of such Supplied Item at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet Cardiome’s or its designee’s address for delivery specified in the applicable specificationspurchase order (or, Supplier in the case of any Latent Defect, within [*] after discovery by Cardiome of the Latent Defect, but [*]). Should Cardiome fail to give written notice of rejection to SteadyMed within [*] after such receipt or [*] after discovery of a Latent Defect, as applicable, then the Supplied Item will be deemed to have been accepted by Cardiome on the [*] after such receipt or the [*] after discovery of the Latent Defect, as applicable. (b) Promptly after timely delivery to SteadyMed of any notice of rejection, Cardiome shall cooperate with SteadyMed in determining whether such rejection is necessary or justified. SteadyMed will evaluate process issues and other reasons for any non-conformity. SteadyMed shall notify Cardiome as promptly as reasonably possible whether it accepts Cardiome’s basis for any rejection. Whether or not SteadyMed accepts Cardiome’s assertion that certain Supplied Item is Defective Product, SteadyMed shall use Commercially Reasonable Efforts to replace such shipment of Components allegedly Defective Product with Supplied Item that conforms to Purchaser, at Purchaser's expensethe Product Warranty as promptly as practicable. If Supplier SteadyMed disagrees with Purchaser's determination Cardiome’s assertion that the rejected shipment did not meet the applicable specificationscertain Supplied Item is Defective Product, a sample of the rejected shipment Supplied Item shall be submitted to an independent, qualified a mutually acceptable independent Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory laboratory, which shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such Supplied Item is Defective Product. The Parties agree that such laboratory's ’s determination shall be final and determinative for purposes of this Agreementbinding upon the Parties. The Party against whom the Third Party laboratory rules shall bear all the reasonable costs of the laboratory such testing. If the Third Party laboratory rules that the shipment Supplied Item is not Defective Product, Cardiome shall purchase such Supplied Item at the agreed-upon price, irrespective of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier whether SteadyMed has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Componentsalready replaced it.

ACCEPTANCE AND REJECTION. Purchaser Each shipment shall have be deemed accepted by ORPHAN and considered to conform to the right to test at its expense, using testing procedures agreed upon by Specifications and the Parties and other warranties set forth in Section 8.1(b) which relate to quality unless ORPHAN gives Catalytica notice in writing that it does not consider a particular shipment to conform, together with supporting documentation specifying the specifications for manner in which the applicable ComponentProduct fails to meet such warranties or the Specifications, a portion within thirty (30) days of receipt of such shipment (or, in the case of nonconformity that could not be reasonably discovered by ORPHAN’S analysis within ten (10) days of such discovery). ORPHAN will analyze (or cause to be analyzed by its designated product manufacturer) each shipment of Components Product using the validated methods approved by the FDA for release of Product. Such testing will be done for acceptance or rejection of the lot. If ORPHAN gives Catalytica notice of rejection, Catalytica shall thereupon be given access to confirm the shipment in question to conduct its own analysis thereof, and the parties will endeavor to agree amicably as to whether or not the shipment does conform to the Specifications and such other warranties and, if not, whether such non-compliance was due to any breach on the part of Catalytica. In the event that such the parties are unable to agree as to whether or not the shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance conforms with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects Specifications or other warranties set forth in whole or in part any nonconforming shipment of ComponentsSection 8.1(b), Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall question will be submitted to an independent, qualified Third Party independent quality control laboratory that is which the parties shall mutually acceptable and selected agree upon. Cost for the independent quality control laboratory shall be borne by the Parties promptly in good faithparty whose results are shown by such laboratory to have been wrong. Such During the pendency of a dispute that requires settlement by an independent laboratory shall determine whether the rejected Components (as applicable) meet the applicable specificationsunder this section, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed if requested to meet the applicable specificationsdo so by ORPHAN, Catalytica will replace, at Purchaser's choiceORPHAN’S expense, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, portion of such shipment of Componentsunder dispute until such dispute is resolved.

ACCEPTANCE AND REJECTION. Purchaser (a) Lilly shall be allowed a maximum of ninety (90) days from the date of receipt of any shipment for inspection to provide written notice to Amylin of rejection of any portion or all of that shipment (“Inspection Period”). If Lilly does not deliver such written notice to Amylin within such Inspection Period, Lilly shall be deemed to have accepted the right to test at its expenseshipment, using testing procedures agreed upon by the Parties and set forth except in the specifications for the applicable Component, a portion case of each shipment Latent Defects. (b) Promptly following Amylin’s receipt of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written Lilly’s notice of such rejection. If Supplier agrees with Purchaser's determination that a , Amylin and Lilly shall mutually determine whether the rejected shipment of Components does not comply with applicable specificationsconformed to the Specifications and warranties and, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that if the rejected shipment did not meet the applicable specificationsso conform, a sample of in what ways the rejected shipment shall be submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected did not so conform. If the Parties cannot agree upon such issue by the Parties promptly end of the Inspection Period, then the head of Quality (or any successor position) of Amylin and the head of Quality (or any successor position) of Lilly shall mutually determine in good faith. Such laboratory shall determine faith whether the rejected Components (shipment conformed to the Specifications and warranties, using such further testing procedures as applicable) meet such individuals may agree. Such individuals may submit the applicable specificationsrejected items to a mutually acceptable, independent laboratory for determination of whether such items conformed to the Specifications and warranties, if such laboratory's determination shall be final individuals cannot reach agreement regarding whether the shipment conformed to the Specifications and determinative for purposes of this Agreementwarranties or such individuals agree that such a submission is appropriate. The non-prevailing Party against whom the laboratory rules shall bear all reasonable costs of such independent laboratory assessment. Lilly shall provide to Amylin samples of rejected EQW Product, as Amylin shall reasonably request for the laboratory testing. purpose of performing additional testing pursuant to this Section 7.3. (c) If the laboratory rules it is determined that the shipment of Components failed to meet the applicable specificationsrejected EQW Product was non-conforming, then Amylin shall replace such EQW Product as promptly as practicable, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option Amylin’s sole cost and expense, or refund to Lilly the amounts paid by Lilly with respect to such EQW Product, as Lilly may elect. Amylin shall reimburse Lilly for Lilly’s cost of return or disposal of rejected, non-conforming EQW Product. Non-conforming EQW Product shall be returned to Supplier Amylin or destroyed disposed of, as directed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of ComponentsAmylin.

ACCEPTANCE AND REJECTION. Purchaser shall have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance (a) SGI may reject any quality control sample or batch delivery which does not conform with the Product Specifications or applicable specifications documentation and process requirements. Any such notice of rejection shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser writing and shall immediately provide Supplier written notice of indicate the reasons for such rejection. [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) In order to reject a quality control sample, SGI must give written notice to Supplier of SGI’s rejection of any delivery within [***] after receipt of the applicable quality control sample or [***] after receipt of the associated documentation, whichever is later (the “Acceptance Period”). If Supplier agrees with Purchaser's determination that a shipment no such notice of Components does not comply with applicable specificationsrejection is received, SGI shall be deemed to have accepted such quality control sample upon the expiration of the Acceptance Period, and Supplier shall use Reasonable be authorized to make delivery of the full batch of such Product. (c) In order to reject delivery of a full batch of Product, SGI must give written notice to Supplier of SGI’s rejection of any delivery within [***] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaserafter receipt of such delivery. If no such notice of rejection is received, SGI shall be deemed to have accepted such delivery of Product within [***] of delivery of the batch. Once SGI accepts a batch of Product, SGI [***], except as provided in Section 6 below. (d) After notice of rejection is given, SGI’s head of Quality Assurance and Supplier’s head of Quality, or their delegated representatives, shall cooperate in determining whether rejection is necessary or justified. Supplier reasonably disputes Purchaser's conclusion that will evaluate process issues and other reasons for such Components do not meet the applicable specifications, non-compliance. Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expensenotify SGI as promptly as reasonably possible whether it accepts SGI’s basis for any rejection. If Supplier disagrees with Purchaser's SGI’s determination that the rejected shipment did certain Product does not meet the applicable specificationsProduct Specifications, a sample of the rejected shipment such Product shall be submitted to an independent, qualified Third Party laboratory that is a mutually acceptable and selected by the Parties promptly in good faiththird party laboratory. Such third party laboratory shall determine whether such Product meets the rejected Components (as applicable) meet Product Specifications and the applicable specifications, and parties agree that such laboratory's ’s determination shall be final and determinative for purposes of this Agreementdeterminative. The Party party against whom the third party laboratory rules shall bear all costs of the laboratory third party testing. Whether or not Supplier accepts SGI’s basis for rejection, promptly on receipt of a notice of rejection of a full batch of such Product, Supplier shall use reasonable efforts at SGI’s request to replace such rejected Product. If the third party laboratory rules that the shipment samples submitted to it meet Product Specifications, [***]. (e) SGI may not destroy any batch of Components failed rejected Product until it receives written notification from Supplier that Supplier does not dispute that the batch fails to meet specifications and that Supplier does not request return of the applicable specificationsProduct. Upon authorization from Supplier to do so, SGI shall destroy any Product received in the rejected delivery promptly at [***] and provide Supplier with certification of such destruction. SGI shall, upon receipt of Supplier’s request for return, promptly return said Product or quality control sample to Supplier, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components[***].

ACCEPTANCE AND REJECTION. (a) Purchaser may reject any batch delivery which does not conform with the Materials Specifications or to applicable documentation and process requirements. Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. (b) In order to reject delivery of a full batch of Current Materials or Commercial Materials, Purchaser must give written notice to Supplier of Purchaser’s rejection of any delivery within [*****] after receipt of such delivery. If no such notice of rejection is timely received, Purchaser shall be deemed to have accepted such delivery of Current Materials or Commercial Materials within [*****] of delivery of the batch. Once Purchaser accepts a batch of Current Materials or Commercial Materials, Purchaser shall have no recourse against Supplier if the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications product is subsequently deemed unsuitable for the applicable Component, a portion use for any reason except for Latent Defects. (c) After notice of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it rejection is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Componentsgiven, Purchaser shall immediately provide cooperate with Supplier written notice of in determining whether rejection is necessary or justified. Supplier will evaluate process issues and other reasons for such non-compliance. Supplier shall notify Purchaser as promptly as reasonably possible whether it accepts Purchaser’s basis for any rejection. If Supplier agrees in good faith disagrees with Purchaser's ’s determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components certain Current Materials or Commercial Materials do not meet the applicable specificationsMaterials Specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment Current Materials or Commercial Materials shall be submitted to an independent, qualified a mutually acceptable Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faithlaboratory. Such Third Party laboratory shall determine whether such Current Materials or Commercial Materials meets the rejected Components (as applicable) meet Materials Specifications and the applicable specifications, and parties agree that such laboratory's ’s determination shall be final and determinative for purposes of this Agreementdeterminative. The Party party against whom the laboratory Third Party tester rules shall bear all costs of the laboratory Third Party testing. Whether or not Supplier accepts Purchaser’s basis for rejection, promptly on receipt of a notice of rejection of a full batch of Current Materials or Commercial DexCom Confidential Materials, Supplier shall use reasonable efforts at Purchaser’s request to replace such rejected Current Materials or Commercial Materials. If the laboratory Third Party tester rules that the shipment batch meets Materials Specifications, Purchaser shall purchase that batch and any replacement batch at the agreed-upon price, irrespective of Components failed whether Supplier has already replaced it. (d) Purchaser may not destroy any batch of Current Materials or Commercial Materials until it receives written notification from Supplier that Supplier does not dispute that the batch fails to meet Materials Specifications and that Supplier does not request return of the applicable specificationsCurrent Materials or Commercial Materials. Upon authorization from Supplier to do so, at Purchaser's choice, Purchaser shall destroy the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) Current Materials or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules Commercial Materials received in the rejected shipment delivery promptly at Supplier’s cost and provide Supplier with certification of Components met the applicable specificationssuch destruction. Purchaser shall, then Purchaser shall accept such shipment (including all costs upon receipt of shipping and insurance). Shipments of Components not meeting the applicable specifications maySupplier’s request for return, promptly return said Current Materials or Commercial Materials or quality control sample to Supplier, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components’s cost.

ACCEPTANCE AND REJECTION. Purchaser shall have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejectionrejection no later than thirty (30) days after receipt of such shipment of Components. If Purchaser fails to provide Supplier with such notice of 12. rejection within such thirty (30) day inspection period, Purchaser shall be deemed to have accepted the applicable shipment of Components. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, then at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped shipped. If the laboratory rules that the Components do not meet the applicable specifications, and if Supplier is unable to produce conforming Components, any sums actually paid therefore shall be refunded to Purchaser by Supplierwith interest. At such time, the Parties will discuss in good faith potential solutions to the supply problem. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7refunded. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components.

ACCEPTANCE AND REJECTION. Purchaser GSL may reject API delivered by Degussa for failure to comply with the warranties in Section 13 by giving Degussa written notice. Any rejection for noncompliance with such warranties shall be made within [ * ] days of GSL’s receipt of the Quality Documentation, as such period may be reasonably extended by notice from GSL in the event of investigation of a potential deviation by GSL. GSL will be deemed to have accepted any shipment of API that it does not reject consistent with the right to test at its expensepreceding timeframe. In case of notice of rejection by GSL, using testing procedures agreed upon by the Parties will cooperate to determine whether rejection was necessary or justified. Degussa will notify GSL promptly as to whether it accepts GSL’s basis for any rejection, and set forth in the specifications for the applicable Component, a portion no event later than [ * ] days after receipt of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written GSL’s notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does the Parties disagree whether the API batch did not comply with the warranties, they will submit a sample of such API batch and applicable specificationsdocumentation to a mutually acceptable independent third-party laboratory. Such third-party laboratory will determine whether such API batch conforms to the warranties, Supplier and such determination shall be final, binding and determinative as to whether rejection of such API batch was justified. The Party against whom the third-party tester rules will bear all costs of the third-party testing. If the third-party tester rules that a rejected batch meets the warranties, GSL will purchase such batch, irrespective of whether Degussa has already replaced it. If Degussa accepts GSL’s basis for rejection or the third-party tester rules that a rejected batch did not meet the warranties, Degussa will not charge GSL for such batch or for shipping, insurance or freight costs therefor, or will promptly refund any such amounts already paid by GSL. At GSL’s request, Degussa will use Reasonable [*its commercially reasonable efforts to replace any rejected API within (i) [ * ] days of the date of Degussa’s acceptance of GSL’s basis for rejection or (ii) [ * ] days after the date of Degussa’s rejection of GSL’s [ ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND IS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 24B-2 OF THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. Efforts to replace the nonconforming ComponentsAMENDED notice of rejection of API; provided that if Degussa does not accept or reject GSL’s notice of rejection of API, at no additional cost to Purchasersuch rejection of API will be deemed accepted by Degussa 15 days after Degussa’s receipt of GSL’s notice. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts Degussa fails to replace such shipment API within the time period required in the previous sentence, GSL may treat the rejected batch of Components API as a Shortfall pursuant to PurchaserSection 3(f), at Purchaser's expense. If Supplier disagrees with Purchaser's determination until and unless it is finally determined that the rejected shipment did not meet batch complied with the applicable specifications, a sample of the rejected shipment shall be submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by the Parties promptly warranties in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components13.

ACCEPTANCE AND REJECTION. Purchaser GWM may reject Product delivered by PharmaChem for failure to comply with the warranties in Section 13 by giving PharmaChem written notice. Any rejection for noncompliance with such warranties that is based on shall be made within thirty (30) days of GWM’s receipt of the Quality Documentation, as such period may be reasonably extended by notice from GWM in the event of investigation of a potential deviation by GWM. GWM will be deemed to have accepted any shipment of Product that it does not reject consistent with the right to test at its expensepreceding timeframe. In case of notice of rejection by GWM, using testing procedures agreed upon by the Parties and set forth in the specifications will cooperate to determine whether rejection was necessary or justified. PharmaChem will notify GWM promptly as to whether it accepts GWM’s basis for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does the Parties disagree whether the Product batch did not comply with applicable specificationsthe warranties, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, they will submit a sample of the rejected shipment shall be submitted such Product batch and applicable documentation to an independent, qualified Third Party laboratory that is a mutually acceptable and selected by the Parties promptly in good faithindependent third party laboratory. Such third party laboratory shall will determine whether such Product batch conforms with the rejected Components (as applicable) meet the applicable specificationswarranties, and such laboratory's determination shall be final final, binding and determinative for purposes as to whether rejection of this Agreementsuch Product batch was justified. The Party against whom the laboratory third party tester rules shall will bear all costs of the laboratory third party testing. If the laboratory rules that the shipment GWM has given notice of Components failed to meet the applicable specificationsrejection, at Purchaser's choice, the price paid by Purchaser for GWM’s request PharmaChem will use best efforts to replace such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplierrejected Product. If the laboratory third party tester rules that a rejected batch meets the rejected shipment warranties, GWM will purchase such batch, irrespective of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaserwhether PharmaChem has already replaced it. If Supplier has acknowledged in writing PharmaChem accepts GWM’s basis for rejection or the third party tester rules that a rejected batch did not meet the warranties, PharmaChem will not charge GWM for such batch or for shipping, insurance or freight costs therefor, or will promptly refund any such amounts already paid by GWM. At its election, [ * ], until and unless it is unable to produce conforming Components, any sums actually paid therefor will be refunded finally determined that the batch complied with interest, and the supply problem will be resolved warranties in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components13.

ACCEPTANCE AND REJECTION. (a) Purchaser may reject any batch delivery which does not conform with the Materials Specifications or with applicable documentation and process requirements. Any such notice of rejection shall be in writing and shall indicate the reasons for such rejection. (b) Reserved. (c) In order to reject delivery of a full batch of Materials, Purchaser must give written notice to Supplier of Purchaser’s rejection of any delivery within [******] after receipt of such delivery. If no such notice of rejection is timely received, Purchaser shall be deemed to have accepted such delivery of Materials within [******]of delivery of the batch. Once Purchaser accepts a batch of Materials, Purchaser shall have no recourse against Supplier if the right to test at its expenseproduct is subsequently deemed unsuitable for use for any reason, using testing procedures agreed upon by the Parties and set forth except for Latent Defects or as provided in the specifications for the applicable Component, a portion Article 10 below. (d) After notice of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it rejection is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Componentsgiven, Purchaser shall immediately provide cooperate with Supplier written notice of in determining whether rejection is necessary or justified. Supplier will evaluate process issues and other reasons for such non-compliance. Supplier shall notify Purchaser as promptly as reasonably possible whether it accepts Purchaser’s basis for any rejection. If Supplier agrees in good faith disagrees with Purchaser's ’s determination that a shipment of Components certain Materials does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specificationsMaterials Specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment Materials shall be submitted to an independent, qualified a mutually acceptable Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faithlaboratory. Such Third Party laboratory shall determine whether such Materials meets the rejected Components (as applicable) meet Materials Specifications and the applicable specifications, and parties agree that such laboratory's ’s determination shall be final and determinative for purposes of this Agreementdeterminative. The Party party against whom the laboratory Third Party tester rules shall bear all costs of the laboratory Third Party testing. Whether or not Supplier accepts Purchaser’s basis for rejection, promptly on receipt of a notice of rejection of a full batch of Materials, Supplier shall use reasonable efforts at Purchaser’s request to replace such rejected Materials. If the laboratory Third Party tester rules that the shipment batch meets Materials Specifications, Purchaser shall purchase that batch and any replacement batch at the agreed-upon price, irrespective of Components failed whether Supplier has already replaced it. (e) Purchaser may not destroy any batch of Materials until it receives written notification from Supplier that Supplier does not dispute that the batch fails to meet Materials Specifications and that Supplier does not request return of the applicable specificationsMaterials. Upon authorization from Supplier to do so, at Purchaser's choice, Purchaser shall destroy the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules Materials received in the rejected shipment delivery promptly at Supplier’s cost and provide Supplier with certification of Components met the applicable specificationssuch destruction. Purchaser shall, then Purchaser shall accept such shipment (including all costs upon receipt of shipping and insurance). Shipments of Components not meeting the applicable specifications maySupplier’s request for return, promptly return said Materials or quality control sample to Supplier, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components’s cost.

ACCEPTANCE AND REJECTION. Purchaser shall have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be submitted to an independent, 62. qualified Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components.

ACCEPTANCE AND REJECTION. Purchaser 5.3.1 UCB shall have deliver to Buyer, concurrently with the right to test at its expensedelivery of each shipment, using testing procedures agreed upon by the Parties a certificate of analysis and other documents and materials set forth in the specifications for the applicable Component, a portion Quality Agreement. Within ten (10) days after receipt of each any shipment of Components Finished Product, Buyer shall assess the quantity and visually inspect the quality of the Finished Product. Within thirty (30) days after delivery of Finished Product to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation Buyer in accordance with Section 7, Buyer shall examine the Finished Product to determine whether the Finished Product conforms to the Specifications. No claim for defective quality or shortage in quantity of any individual shipment of Finished Product shall be valid unless made by written notice given within thirty (30) days from the date of delivery, except in the case of latent (or other non-obvious) defects, in which case such claims shall be made in writing within thirty (30) days from the date such defect became discoverable (but in no event later than the date upon which the Finished Product has expired according to its expiry date). Any such notice shall describe in reasonable detail the defect or non-conformity, and shall include samples of the Finished Product being rejected, if appropriate, and copies of written reports relating to tests, studies or investigations performed by or on behalf of Buyer on the Finished Product being rejected. Failure to deliver a notice of non-conformance in the manner contemplated in this Section 5.3.1 shall constitute an acceptance of the applicable specifications shall be carried out Finished Product by Purchaser. Buyer. 5.3.2 If Purchaser rejects there is any dispute as to whether any shipment fails, in whole or in part part, to meet the Specifications, such dispute shall be resolved by an independent testing organization of recognized repute within the pharmaceutical industry in the Territory appointed by both UCB and Buyer. The expense of hiring such organization shall be borne by the Party against whom the decision is rendered. 5.3.3 UCB shall make up any nonconforming shipment of Componentsshortfall and/or replace any non-conforming Finished Product or rework the rejected Finished Product, Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specificationsif applicable, Supplier shall use Reasonable [*] = 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. Efforts to replace the nonconforming Components, as promptly as practicable and at no additional cost to PurchaserBuyer; provided that UCB shall have no liability or obligation to Buyer under this Section 5.3 if it is determined that any such defect or non-conformance is attributable to the failure by any Person (including Buyer) to store, transport or care for such Finished Product in a proper manner after such Finished Product left UCB's possession. If Supplier reasonably disputes PurchaserUpon UCB's conclusion instructions, Buyer shall destroy or return, in either case at UCB's cost, the non-conforming Finished Product; provided that if it is determined that any such Components do not meet defect or non-conformance is attributable to the applicable specificationsfailure by any Person (including Buyer) to store, Supplier transport or care for such Finished Product in a proper manner after such Finished Product left UCB's possession, such destruction or return shall use Reasonable Efforts to replace such shipment be at Buyer's cost. It is acknowledged and agreed that notwithstanding any other provision of Components to Purchaserthis Agreement, at PurchaserBuyer's expense. If Supplier disagrees with Purchasersole and exclusive remedy in the event of UCB's determination that the rejected shipment did not meet the applicable specifications, a sample delivery of defective or non-conforming Finished Product shall be replacement of the rejected shipment shall be submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved Finished Product in accordance with this Section 3.7. The remedy 5.3.3, and that Buyer shall not be entitled to remedies, whether under any other provision of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, this Agreement (including without limitation storage at inappropriate temperatures, of such shipment of ComponentsSection 6.4) or otherwise.

ACCEPTANCE AND REJECTION. Purchaser shall have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejectionrejection no later than thirty (30) days after receipt of such shipment of Components. If Purchaser fails to provide Supplier with such notice of rejection within such thirty (30) day inspection period, Purchaser shall be deemed to have accepted the applicable shipment of Components. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Supplier shall use Reasonable Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, then at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped shipped. If the laboratory rules that the Components do not meet the applicable specifications, and if Supplier is unable to produce conforming Components, any sums actually paid therefore shall be refunded to Purchaser by Supplierwith interest. At such time, the Parties will discuss in good faith potential solutions to the supply problem. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7refunded. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components.

ACCEPTANCE AND REJECTION. Purchaser VIACELL shall have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications Specifications for the applicable Component, a portion of each shipment of Components Cell Separation Kit to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by PurchaserSpecifications. If Purchaser VIACELL rejects in whole or in part any nonconforming shipment of ComponentsCell Separation Kits, Purchaser VIACELL shall immediately provide Supplier MILTENYI written notice of such rejectionrejection no later than [**] days after receipt of such shipment of Cell Separation Kits. If Supplier VIACELL fails to provide MILTENYI with such notice of rejection within such [**] day inspection period, VIACELL shall be deemed to have accepted the applicable shipment of Cell Separation Kits. 3.7.1 If MILTENYI agrees with PurchaserVIACELL's determination that a shipment of Components Cell Separation Kits does not comply with applicable specificationsSpecifications, Supplier shall use Reasonable then MILTENY shall, [*] = 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. Efforts to replace the nonconforming Components, at no additional cost to Purchaser. *]. 3.7.2 If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier MILTENYI disagrees with PurchaserVIACELL's determination that the rejected shipment did not meet the applicable specificationsSpecifications, a sample of the rejected shipment shall be submitted provided by VIACELL to an independentMILTENYI. [**]. (a) If the shipment of Cell Separation Kits failed to meet the applicable Specifications, qualified Third Party laboratory that is mutually acceptable then MILTENY shall, [**] use reasonable efforts to replace the nonconforming Cell Separation Kits with Cell Separation Kits meeting the applicable Specifications at no additional cost to VIACELL and selected by MILTENYL shall bear all costs of the Parties promptly in good faith. Such laboratory shall determine whether testing pursuant to Section 3.7.2. (b) If the rejected Components (as applicable) [**] the Cell Separation Kit does not meet the applicable specifications, and [**]. At such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choicetime, the price paid by Purchaser for such nonconforming shipment shall be reimbursed Parties will discuss in good faith potential solutions to Purchaser the supply problem. (provided Purchaser paid for such shipmentc) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules [**] the rejected shipment of Components Cell Separation Kits met the applicable specifications, then Purchaser VIACELL shall accept such shipment (including all costs of shipping and insurance). ) and VIACELL shall bear all costs of the testing pursuant to Section 3.7.2. 3.7.3 Shipments of Components Cell Separation Kits not meeting the applicable specifications may, at SupplierMILTENYI's option and expense, be returned to Supplier MILTENYI or destroyed by PurchaserVIACELL. If Supplier MILTENYI has acknowledged in writing that it is unable to produce conforming ComponentsCell Separation Kits, any sums actually paid therefor therefore will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. refunded. 3.7.4 The remedy of replacement or refund is available only if such nonconformance was not caused by PurchaserVIACELL's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of ComponentsCell Separation Kits, including, but not limited to, any nonconformance due to or the results of the shipping of the Cell Separation Kits.

ACCEPTANCE AND REJECTION. Purchaser In the event that any SUNBRIGHT [**] delivered to Apellis or any Apellis designated location fails to conform to the Specifications, was not Manufactured in accordance with cGMP or the Quality Agreement, is damaged or defective, is otherwise adulterated or misbranded under applicable Laws, or has not been stored or shipped in such a manner that ensures maintenance of the appropriate physical and temperature conditions or has obvious defects, Apellis may reject such Batch by providing NOF written notice within [**] of the Delivery of the SUNBRIGHT [**]. Obvious defects shall include any defects reasonably discoverable on visual examination of representative samples of a consignment. Apellis shall notify NOF in writing of any non-obvious defects promptly upon discovery thereof but in no event later than after the Shelf Life of the applicable SUNBRIGHT [**] that are not rejected within the foregoing applicable period will be deemed to have the right been accepted by Apellis, and any defect or nonconformity thereof will be deemed waived by Apellis. Apellis shall use commercially reasonable efforts to test a quantity of the SUNBRIGHT [**] delivered by NOF in order to verify that such quantity satisfies the Specifications. Any notice of rejection given hereunder shall specify the applicable nonconformity and furnish such other written evidence or other documentation as may be reasonably requested by NOF. Apellis shall ship, at its NOF’s expense, using such allegedly nonconforming SUNBRIGHT [**] to NOF’s facility for inspection and testing procedures agreed upon by NOF and, if NOF’s inspection and testing reveals to NOF’s reasonable satisfaction or the Parties and independent laboratory confirms pursuant to Section 7.3 or it is resolved pursuant to arbitration set forth in Section 15.16 that any quantity of the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required SUNBRIGHT [**] supplied by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components NOF does not comply with applicable specificationsconform to the Specifications or is otherwise defective, Supplier shall use Reasonable NOF shall, at Apellis’s discretion, either (a) replace such nonconforming SUNBRIGHT [**] = 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. Efforts to replace the nonconforming Components, in a timely manner at no additional cost to PurchaserApellis or (b) refund Apellis the total Supply Price paid or payable by Apellis with respect to such non-conforming SUNBRIGHT [**]. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet Any dispute between the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment Parties regarding the quality of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample any quantity of the rejected shipment SUNBRIGHT [**] supplied shall be submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with the procedure set forth in Section 3.77.3. The remedy Parties shall determine in good faith how to dispose of replacement any nonconforming SUNBRIGHT [**], provided that Apellis shall have no financial liability for the disposition or refund is available only if such nonconformance was not caused by Purchaser's misuseresale of nonconforming SUNBRIGHT [**]. EXCEPT FOR SUCH OTHER REMEDIES AND OBLIGATIONS SET FORTH IN THIS AGREEMENT, unauthorized modificationsINCLUDING NOF’S INDEMNIFICATION OBLIGATIONS AND APELLIS’S RIGHT TO TERMINATE THIS AGREEMENT, neglectTHIS SECTION 7.2 SETS FORTH THE SOLE REMEDY OF APELLIS AND ENTIRE LIABILITY OF NOF FOR FAILURE OF SUNBRIGHT [**] TO CONFORM TO THE SPECIFICATIONS OR FOR THE SALE OF SUNBRIGHT [**] THAT IS DEFECTIVE, improper testing or improper storageOR IS OTHERWISE ADULTERATED OR MISBRANDED UNDER APPLICABLE LAWS, including without limitation storage at inappropriate temperatures, of such shipment of ComponentsOR HAS NOT BEEN MANUFACTURED IN ACCORDANCE WITH CGMP OR THE QUALITY AGREEMENT OR OTHERWISE STORED OR SHIPPED IN SUCH A MANNER THAT ENSURES MAINTENANCE OF THE APPROPRIATE PHYSICAL AND TEMPERATURE CONDITIONS.

ACCEPTANCE AND REJECTION. Purchaser Each shipment shall have be deemed accepted by ORPHAN and considered to conform to the right to test at its expense, using testing procedures agreed upon by Specifications and the Parties and other warranties set forth in the specifications for the applicable Component, a portion of each shipment of Components Section 8.1(b) which relate to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation quality unless ORPHAN gives Catalytica notice in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*[ * ] = 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. Efforts writing that it does not consider a particular shipment to replace conform, together with supporting documentation specifying the nonconforming Componentsmanner in which the Product fails to meet such warranties or the Specifications, at no additional cost within [ * ] of receipt of such shipment (or, [ * ] within [ * ]. ORPHAN will analyze (or cause to Purchaserbe analyzed by its designated product manufacturer) each shipment of Product using the validated methods approved by the FDA for release of Product. Such testing will be done for acceptance or rejection of the lot. If Supplier reasonably disputes Purchaser's conclusion that ORPHAN gives Catalytica notice of rejection, Catalytica shall thereupon be given access to the shipment in question to conduct its own analysis thereof, and the parties will endeavor to agree amicably as to whether or not the shipment does conform to the Specifications and such Components do not meet other warranties and, if not, whether such non-compliance was due to any breach on the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment part of Components to Purchaser, at Purchaser's expenseCatalytica. If Supplier disagrees with Purchaser's determination In the event that the rejected parties are unable to agree as to whether or not the shipment did not meet conforms with the applicable specificationsSpecifications or other warranties set forth in Section 8.1(b), a sample of the rejected shipment shall question will be submitted to an independent, qualified Third Party independent quality control laboratory that is which the parties shall mutually acceptable and selected by agree upon. Cost for the Parties promptly in good faith. Such independent quality control laboratory shall determine whether be [ * ]. During the rejected Components (as applicable) meet pendency of a dispute that requires settlement by an independent laboratory under this section, if requested to do so by ORPHAN, Catalytica will replace[ * ] the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, portion of such shipment of Componentsunder dispute until such dispute is resolved.

ACCEPTANCE AND REJECTION. Purchaser shall have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each a. 3SBio may reject any shipment of Components Product that does not conform with the Specifications by giving written notice to confirm that AMAG within fifteen (15) days after receipt of such delivery. Such notice shall identify the reasons for 3SBio’s rejection of the shipment. If no such notice of rejection is received by AMAG within such fifteen (15) day period, 3SBio shall be deemed to have accepted such shipment meets the applicable specificationsof Product. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejection. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. b. After notice of rejection is received by AMAG, 3SBio shall cooperate with AMAG in determining whether rejection is necessary or justified. Efforts to replace AMAG will evaluate process issues and other reasons for non-compliance with the nonconforming Components, at no additional cost to PurchaserSpecifications. AMAG shall notify 3SBio as promptly as reasonably possible whether it accepts 3SBio’s basis for any rejection. If Supplier reasonably disputes Purchaser's conclusion AMAG disagrees with 3SBio’s determination that such Components do certain Product does not meet the applicable specificationsSpecifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment Product shall be submitted to an independent, qualified a mutually acceptable Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faithlaboratory. Such Third Party laboratory shall determine whether such Product meets the rejected Components (as applicable) meet the applicable specificationsSpecifications, and the Parties agree that such laboratory's ’s determination shall be final and determinative for purposes of this Agreementdeterminative. The Party against whom the Third Party laboratory rules shall bear all costs of the laboratory Third Party testing. If such laboratory determines or the laboratory rules Parties agree that such shipment has been mistakenly rejected, then such shipment shall automatically be deemed to have been accepted by 3SBio, and 3SBio shall pay the Product Price for the quantities of Product initially rejected by 3SBio. c. 3SBio may not destroy any rejected shipment of Components failed Product until it receives written notification from AMAG that AMAG does not dispute that such shipment fails to meet Specifications and that AMAG does not request return of the applicable specificationsProduct. Upon authorization from AMAG to do so, at Purchaser's choice, 3SBio shall destroy the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped to Purchaser by Supplier. If the laboratory rules Product received in the rejected shipment promptly at AMAG’s cost and provide AMAG with certification of Components met the applicable specificationssuch destruction. 3SBio shall, then Purchaser shall accept upon receipt of AMAG’s request for return, promptly return such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications mayrejected Product to AMAG, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce AMAG’s cost. d. 3SBio’s remedies for non-conforming Components, any sums actually paid therefor quantities of Product will be refunded with interest, and the supply problem will be resolved as set forth in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components6.2 below.

ACCEPTANCE AND REJECTION. Purchaser shall have the right to test at its expense, using testing procedures agreed upon by the Parties and set forth in the specifications for the applicable Component, a portion of each shipment of Components to confirm that such shipment meets the applicable specifications. Where it is required by local regulations, further testing on importation in accordance with the applicable specifications shall be carried out by Purchaser. If Purchaser rejects in whole or in part any nonconforming shipment of Components, Purchaser shall immediately provide Supplier written notice of such rejectionrejection no later than thirty (30) days after receipt of such shipment of Components. If Purchaser fails to provide Supplier with such notice of rejection within such thirty (30) day inspection period, Purchaser shall be deemed to have accepted the applicable shipment of Components. If Supplier agrees with Purchaser's determination that a shipment of Components does not comply with applicable specifications, Supplier shall use Reasonable [*] = 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. Supplier shall use Reasonable Efforts to replace the nonconforming Components, at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such Components do not meet the applicable specifications, Supplier shall use Reasonable Efforts to replace such shipment of Components to Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's determination that the rejected shipment did not meet the applicable specifications, a sample of the rejected shipment shall be submitted to an independent, qualified Third Party laboratory that is mutually acceptable and selected by the Parties promptly in good faith. Such laboratory shall determine whether the rejected Components (as applicable) meet the applicable specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment of Components failed to meet the applicable specifications, then at Purchaser's choice, the price paid by Purchaser for such nonconforming shipment shall be reimbursed to Purchaser (provided Purchaser paid for such shipment) or Components meeting the applicable specifications shall be shipped shipped. If the laboratory rules that the Components do not meet the applicable specifications, and if Supplier is unable to produce conforming Components, any sums actually paid therefore shall be refunded to Purchaser by Supplierwith interest. At such time, the Parties will discuss in good faith potential solutions to the supply problem. If the laboratory rules the rejected shipment of Components met the applicable specifications, then Purchaser shall accept such shipment (including all costs of shipping and insurance). Shipments of Components not meeting the applicable specifications may, at Supplier's option and expense, be returned to Supplier or destroyed by Purchaser. If Supplier has acknowledged in writing that it is unable to produce conforming Components, any sums actually paid therefor will be refunded with interest, and the supply problem will be resolved in accordance with Section 3.7. The remedy of replacement or refund is available only if such nonconformance was not caused by Purchaser's misuse, unauthorized modifications, neglect, improper testing or improper storage, including without limitation storage at inappropriate temperatures, of such shipment of Components.and