Common use of PRODUCT ACCEPTANCE Clause in Contracts

PRODUCT ACCEPTANCE. PRODUCT is subject to Company's acceptance testing to assure conformance to specifications. Supplier shall submit two (unless another number is mutually agreed to) production samples of PRODUCT (referred to herein collectively as or "sample(s)") produced in a continuous run on permanent production tooling to a location designated by Company for examination. Company shall evaluate samples and issue a written acceptance or rejection to Supplier within forty five (45) days after receipt of samples. The failure by Company to reject with cause within such time shall constitute acceptance. Any rejection shall identify the failure to meet specifications in reasonable detail sufficient to allow Supplier to correct the deficiency. If a sample evaluated pursuant to this Section is rejected, Supplier agrees to correct, at its expense, the failure to meet the specifications (referred to herein collectively as "defect") leading to such rejection and resubmit a corrected sample to Company within thirty (30) days after receipt of notice from Company of such defect (collectively referred to herein as the "Corrective Period"). Company shall have thirty (30) days after the resubmitting of the corrected sample to accept or reject such deliverable. If the defects in a rejected sample are not corrected within the Corrective Period or if a resubmitted sample re-tested or re-evaluated by Company during the thirty (30) day re-evaluation period is again rejected, Company may at its option: (a) accept the sample as is; (b) afford Supplier one or more correction extensions; or (c) terminate the applicable SPA and purchase orders issued hereunder without any cost or charge to Company whatsoever, including costs or charges incurred by Supplier in procuring equipment, material and special tooling to perform any part of this Agreement, loss of profits or labor, and materials expended in the production of samples. If Company opts to perform testing at Supplier's facility, Supplier shall allow Company to send a representative(s) to observe and participate in the testing. Supplier shall not make any shipments under this Agreement prior to correction of defects and approval of the production samples. Company will return samples to Supplier.

Appears in 1 contract

Samples: General Agreement for the Procurement of Products and Services and the Licensing of Software (Vina Technologies Inc)

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PRODUCT ACCEPTANCE. PRODUCT is subject to Company's acceptance testing to assure conformance to specifications. Supplier shall submit two (unless another number is mutually agreed to) production samples of PRODUCT (referred to herein collectively as or "sample(s)") produced in a continuous run on permanent production tooling to a location designated by Company for examination. Company shall evaluate samples and issue a written acceptance or rejection to Supplier within forty five (45) days after receipt of samples. The failure by Company to reject with cause within such time shall constitute acceptance. Any rejection shall identify the failure to meet specifications in reasonable detail sufficient to allow Supplier to correct the deficiency. RESTRICTED - PROPRIETARY INFORMATION The information contained herein is for use by authorized employees of the parties hereto only and is not for general use or distribution within or outside of their respective companies except under written agreement. If a sample evaluated pursuant to this Section is rejected, Supplier agrees to correct, at its expense, the failure to meet the specifications (referred to herein collectively as "defect") leading to such rejection and resubmit a corrected sample to Company within thirty (30) days after receipt of notice from Company of such defect (collectively referred to herein as the "Corrective Period"). Company shall have thirty (30) days after the resubmitting of the corrected sample to accept or reject such deliverable. If the defects in a rejected sample are not corrected within the Corrective Period or if a resubmitted sample re-tested or re-evaluated by Company during the thirty (30) day re-evaluation period is again rejected, Company may at its option: (a) accept the sample as is; (b) afford Supplier one or more correction extensions; or (c) terminate the applicable SPA and purchase orders issued hereunder without any cost or charge to Company whatsoever, including costs or charges incurred by Supplier in procuring equipment, material and special tooling to perform any part of this Agreement, loss of profits or labor, and materials expended in the production of samples. If Company opts to perform testing at Supplier's facility, Supplier shall allow Company to send a representative(s) to observe and participate in the testing. Supplier shall not make any shipments under this Agreement prior to correction of defects and approval of the production samples. Company will return samples to Supplier.

Appears in 1 contract

Samples: General Agreement for the Procurement of Products and Services and the Licensing of Software (Vina Technologies Inc)

PRODUCT ACCEPTANCE. PRODUCT is subject 13.1 Circa shall manufacture the Final Product and make it available for pick up in accordance with all applicable laws, rules and regulations including, without limitation, the Final Specifications and all other applicable requirements of the FDA and other governmental authorities having jurisdiction. All Products shipped to Company's acceptance testing to assure conformance to specifications. Supplier Customer shall submit two be accompanied by quality control certificates of analysis signed by a duly authorized laboratory official of Circa confirming that each batch of Products covered by such certificate meets its release Final Specifications and shall be deemed accepted by it unless Customer, acting reasonably and in good faith, shall give written notice of rejection (unless another number is mutually agreed to) production samples of PRODUCT (hereafter referred to herein collectively as or a "sample(s)Rejection Notice") produced in a continuous run on permanent production tooling to a location designated by Company for examination. Company shall evaluate samples and issue a written acceptance or rejection to Supplier Circa within forty five (45) 35 days after receipt pick up of samples. the Product by, on behalf of, or for the account of Customer at Circa's facility. 13.2 The failure by Company to reject with cause within such time Rejection Notice shall constitute acceptance. Any rejection shall identify the failure to meet specifications state in reasonable detail (sufficient to allow Supplier enable Circa to correct identify the deficiencynature of the problem and the tests or studies to be conducted by or on its behalf to confirm or dispute same) the reason why the Final Product is not acceptable to Customer. If the Final Product meets the applicable provisions of the Final Specifications, has been manufactured in accordance with representations and warranties provided herein is labeled as required by the Customer and is provided in quantities specified in a sample evaluated purchase order, Customer shall not be entitled to reject it. Any Rejection Notice shall be accompanied by copies of all written reports relating to tests, studies or investigations performed to that date by or for Customer on the Final Product batch rejected. 13.3 Upon receipt of such Rejection Notice, Circa may require Customer to return the rejected Final Product or samples thereof to Circa for further testing, in which event such Final Product or samples thereof as the case may be, shall be returned by Customer to Circa. If it is later determined by the parties or by an independent laboratory or consultant that Customer was not justified in rejecting the Final Product or that Customer was the cause of or was responsible for the problem, Customer shall reimburse * Confidential information omitted and filed separately with the Commission. Circa for the costs of the return, as well as any other costs or expenses incurred by Circa as a result of the rejection or return. 13.4 Customer's test results or basis for rejection shall be conclusive unless Circa notifies Customer, within 35 days of receipt by Circa of the rejected Final Products or samples that it disagrees with such test results or its responsibility for the problem in question. In the event of such a notice by Circa, representative samples of the batch of the Final Products in question shall be submitted to a mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review, the costs of which shall be paid by the party that is determined by the independent laboratory or consultant to have been incorrect in its determination of whether the Final Product should be rejected. 13.5 If any order of Final Product is rejected by Customer, Customer's duty to pay all amounts payable to Circa in respect of the rejected Final Product shall be suspended until such time as it is determined (i) by an independent laboratory or consultant that the Final Products in question should not have been rejected by Customer or (ii) by the parties or by any arbitration conducted pursuant hereto or by a final order of a court of competent jurisdiction (which is not subject to this Section further appeal) that any act or omission of, on behalf of or for which Customer is responsible was the cause of the problem that was the basis for the rejection. If only a portion of an order is rejected, Supplier agrees only the duty to correct, at its expense, pay the failure to meet the specifications (referred to herein collectively as "defect") leading amount allocable to such rejection portion shall be suspended. 13.6 In the event any Final Product is appropriately rejected by Customer, Circa shall replace such Final Product with conforming goods and resubmit shall be fully responsible for all costs associated with replacing such Final Product, including the cost of the Bulk Product required to replace the Final Product or, if requested by Customer, shall provide a corrected sample credit to Company within thirty Customer for the amount, if any, previously paid by Customer to Circa on account of the Final Product in question and for the full cost of replacing the Bulk Product utilized in the manufacture of the Final Product in question, including any wasted Bulk Product. The credit shall be provided by Circa to Customer immediately following the expiration of the period during which Circa may dispute a Rejection Notice as contemplated above (30) days after receipt unless the Rejection Notice is disputed by Circa, in which event such credit shall be given only if the dispute is resolved in favor of notice from Company of such defect (collectively referred to herein as the "Corrective Period"Customer). Company Replacement Products, as aforesaid, shall have thirty (30) days after be delivered to Customer at no cost to Customer if Customer has already paid for the resubmitting rejected Products and not received a credit therefor, as aforesaid. All delivery costs, including insurance, incident to the return of Final Products to Circa and delivery of the corrected sample replacement Final Products to accept or reject such deliverable. If Customer's order shall be paid by Circa, unless the defects in a rejected sample are rejection is determined not corrected within the Corrective Period or if a resubmitted sample re-tested or re-evaluated by Company during the thirty (30) day re-evaluation period is again to have been appropriately rejected, Company may at its option: (a) accept in which case Customer shall reimburse Circa for the sample costs of the return, as is; (b) afford Supplier one or more correction extensions; or (c) terminate the applicable SPA and purchase orders issued hereunder without well as any cost or charge to Company whatsoever, including other costs or charges expenses incurred by Supplier in procuring equipment, material and special tooling to perform any part of this Agreement, loss of profits or labor, and materials expended in the production of samples. If Company opts to perform testing at Supplier's facility, Supplier shall allow Company to send Circa as a representative(s) to observe and participate in the testing. Supplier shall not make any shipments under this Agreement prior to correction of defects and approval result of the production samples. Company will return samples to Supplierrejection or return.

Appears in 1 contract

Samples: Manufacturing Agreement (Geltex Pharmaceuticals Inc)

PRODUCT ACCEPTANCE. PRODUCT is subject 8.1 SANO shall manufacture the Licensed Products and make them available for pickup by Par in accordance with all applicable laws, rules and regulations including, without limitation, the Specifications applicable to Company's acceptance testing the Licensed Product in question, Current Good Manufacturing Practices of the FDA (as the same may change from time to assure conformance to specifications. Supplier time) and all other applicable requirements of the FDA and other governmental authorities having jurisdiction. 8.2 All Licensed Products made available for pick up by Par shall submit two be accompanied by quality control certificates of analysis signed by a duly authorized laboratory official of SANO confirming that each batch of Licensed Product covered by such certificate meets its release Specifications and shall be deemed accepted by it unless Par, acting reasonably and in good faith, shall give written notice of rejection (unless another number is mutually agreed to) production samples of PRODUCT (hereafter referred to herein collectively as or a "sample(s)Rejection Notice") produced in a continuous run on permanent production tooling to a location designated by Company for examination. Company shall evaluate samples and issue a written acceptance or rejection to Supplier SANO within forty five (45) 35 days after receipt pick up of samples. the Licensed Products by, on behalf of or for the account of Par at SANO's facility. (a) The failure by Company to reject with cause within such time Rejection Notice shall constitute acceptance. Any rejection shall identify the failure to meet specifications state in reasonable detail (sufficient to allow Supplier enable SANO to correct identify the deficiencynature of the problem and the tests or studies to be conducted by or on its behalf to confirm or dispute same) the reason why the Licensed Products are not acceptable to Par. If the Licensed Products meet the applicable provisions of Section 8.1 and are in quantities specified in a sample evaluated purchase order, Par shall not be entitled to reject them. Any Rejection Notice shall be accompanied by copies of all written reports relating to tests, studies or investigations performed to that date by or for Par on the Licensed Product batch rejected. (b) Upon receipt of such Rejection Notice, SANO may require Par to return the rejected Licensed Products or samples thereof to SANO for further testing, in which event such Licensed Products or samples thereof, as the case may be, shall be returned by Par to SANO or, at SANO's direction, at SANO's expense. If it is later determined by the parties or by an independent laboratory or consultant that Par was not justified in rejecting the Licensed Products or that Par or its Affiliates were the cause of or were responsible for the problem, Par shall reimburse SANO for the costs of the return, as well as any other costs or expenses incurred by SANO as a result of the rejection or return. (c) Par's test results or basis for rejection shall be conclusive unless SANO notifies Par, within 30 days of receipt by SANO of the rejected Licensed Products or samples or such longer periods of time as may be reasonable in the circumstances to enable SANO to conduct (and receive the results of) the appropriate tests, studies or investigations which SANO should reasonably conduct to confirm the problem in question and to identify the source thereof, that it disagrees with such test results or its responsibility for the problem in question. In the event of such a notice by SANO, representative samples of the batch of the Licensed Product in question shall be submitted to a mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review, the costs of which shall be paid by the party that is determined by the independent laboratory or consultant to have been responsible for the rejection. (d) If a Licensed Product is rejected by Par, Par's duty to pay the amount payable to SANO pursuant to this Section 7.2 hereof in respect of the rejected Licensed Product shall be suspended until such time as it is determined (i) by an independent laboratory or consultant that the Licensed Product in question should not have been rejected by Par or (ii) by the parties or by any arbitration conducted pursuant hereto or by a final order of a court of competent jurisdiction (which is not subject to further appeal) that any act or omission of, on behalf of or for which Par or its Affiliates is responsible was the cause of the problem that was the basis for the rejection. If only a portion of an order is rejected, Supplier agrees only the duty to correct, at its expense, pay the failure amount allocable to such portion shall be suspended. 8.3 In the event any Licensed Products are appropriately rejected by Par (being Licensed Products that do not meet the specifications applicable provisions of Section 8.1 other than as a result of any act or omission by Par or its Affiliates), SANO shall replace such Licensed Products with conforming goods or, if requested by Par, shall provide a credit to Par for the amount, if any, previously paid by Par to SANO on account of the Licensed Products in question. The credit shall be provided by SANO to Par immediately following the expiry of the period during which SANO may dispute a Rejection Notice as contemplated in Section 8.2(c) above (referred to herein collectively as "defect") leading to unless the Rejection Notice is disputed by SANO, in which event such rejection and resubmit a corrected sample to Company within thirty (30) days after receipt credit shall be given only if the dispute is resolved in favor of notice from Company of such defect (collectively referred to herein as the "Corrective Period"Par). Company Replacement Licensed Products, as aforesaid, shall have thirty (30) days after be delivered to Par at no cost to Par if Par has already paid for the resubmitting rejected Licensed Products and not received a credit therefor, as aforesaid. All delivery costs, including insurance, incident to the return of Licensed Products to SANO and delivery of the corrected sample replacement Licensed Products to accept or reject such deliverable. If Par's Spring Valley facility shall be paid by SANO, unless the defects in a rejected sample are rejection is determined not corrected within the Corrective Period or if a resubmitted sample re-tested or re-evaluated by Company during the thirty (30) day re-evaluation period is again to have been appropriately rejected, Company may at its option: (ain which case the last sentence of Section 8.2(a) accept the sample as is; (b) afford Supplier one or more correction extensions; or (c) terminate the applicable SPA and purchase orders issued hereunder without any cost or charge to Company whatsoever, including costs or charges incurred by Supplier in procuring equipment, material and special tooling to perform any part of this Agreement, loss of profits or labor, and materials expended in the production of samples. If Company opts to perform testing at Supplier's facility, Supplier shall allow Company to send a representative(s) to observe and participate in the testing. Supplier shall not make any shipments under this Agreement prior to correction of defects and approval of the production samples. Company will return samples to Supplierapply.

Appears in 1 contract

Samples: Distribution Agreement (Pharmaceutical Resources Inc)

PRODUCT ACCEPTANCE. PRODUCT is subject to Company's acceptance testing to assure conformance to specifications. Supplier 12.1 All shipments of Product shall submit two be deemed accepted by Customer unless Customer, acting reasonably and in good faith, gives written notice of rejection (unless another number is mutually agreed to) production samples of PRODUCT (hereafter referred to herein collectively as or "sample(sa “Rejection Notice”) to DSM within ** (i) after delivery of such Product or, (ii) where the defect is unable to be discovered at such time, after discovery by Customer of such defect where Customer can establish with reasonably competent and credible evidence with reasonable certainty that the defect resulted from DSM’s breach of its obligations and existed at the time of delivery of the Product (the “Rejected Product”)") produced in a continuous run on permanent production tooling . Subject to a location designated by Company for examination. Company shall evaluate samples and issue a written acceptance or rejection to Supplier within forty five (45) days after receipt the provisions of samples. The failure by Company Section 12, Customer has the right to reject with cause within and return, at the expense of DSM, any portion of any shipment of Rejected Product, without invalidating any remainder of such time shipment. 12.2 The Rejection Notice shall constitute acceptance. Any rejection shall identify the failure to meet specifications state in reasonable detail sufficient the reason why the Product is rejected. Any Rejection Notice shall be accompanied by copies of all written reports relating to allow Supplier tests, studies or investigations performed to correct that date by or for Customer on the deficiencyRejected Product. Customer shall also have the right to report any shortages in shipment in such Rejection Notice, 12.3 Upon receipt of such Rejection Notice and DSM’s written request, Customer shall return, at DSM’s sole expense, the Rejected Product or samples thereof to DSM. Title to and risk of loss associated with the Rejected Product shall transfer to DSM upon delivery of the Rejected Product to a carrier. **. If it is later determined by the parties or by an independent laboratory or consultant mutually agreed to by the parties that Customer was unreasonable in rejecting the Rejected Product, **, as evidenced by adequate documentation. If it is determined that Customer’s rejection was reasonable, **. 12.4 The test results or basis for rejection generated by Customer (or a sample evaluated pursuant Third Party Designee) shall be conclusive, unless DSM (acting reasonably and in good faith) notifies Customer, within ** of receipt by DSM of the Rejection Notice that it disagrees with such test results. In the event of Customer’s receipt of such a notice, representative samples of the batch of the Rejected Product in question shall be submitted to this Section a mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review, the costs of which shall ultimately be paid (i) by Customer should the independent laboratory or consultant determine that Customer’s rejection of the Product was unreasonable or (ii) by DSM should the independent laboratory or consultant determine that Customer’s rejection of the Product was reasonable. The findings of the laboratory or consultant shall be final and conclusively binding on the parties as to whether the rejection was justified, absent manifest error. 12.5 If any Product is rejected by Customer, Customer’s duty to pay all amounts payable to DSM in respect of the Rejected Product shall be (i) suspended until such time as it is determined by an independent laboratory or consultant that the Products in question were unreasonably rejected by Customer or (ii) waived and null and void if it is determined by an independent laboratory or consultant that the Rejected Products were reasonably rejected by Customer. If only a portion of an order is rejected, Supplier agrees only the duty to correct, at its expense, pay the failure to meet the specifications (referred to herein collectively as "defect") leading amount allocable to such rejection and resubmit a corrected sample to Company within thirty (30) days after receipt of notice from Company of such defect (collectively referred to herein portion shall be suspended or waived, as the "Corrective Period"). Company shall have thirty (30) days after the resubmitting of the corrected sample to accept or reject such deliverable. If the defects in a rejected sample are not corrected within the Corrective Period or if a resubmitted sample re-tested or re-evaluated by Company during the thirty (30) day re-evaluation period is again rejected, Company may at its option: (a) accept the sample as is; (b) afford Supplier one or more correction extensions; or (c) terminate the applicable SPA and purchase orders issued hereunder without any cost or charge to Company whatsoever, including costs or charges incurred by Supplier in procuring equipment, material and special tooling to perform any part of this Agreement, loss of profits or labor, and materials expended in the production of samples. If Company opts to perform testing at Supplier's facility, Supplier shall allow Company to send a representative(s) to observe and participate in the testing. Supplier shall not make any shipments under this Agreement prior to correction of defects and approval of the production samples. Company will return samples to Supplierapplicable.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Cti Biopharma Corp)

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PRODUCT ACCEPTANCE. PRODUCT is subject 8.1 SANO shall manufacture the Licensed Products and make them available for pickup by PPI in accordance with all applicable laws, rules and regulations including, without limitation, the Specifications applicable to Company's acceptance testing the Licensed Product in question, Current Good Manufacturing Practices of the FDA (as the same may change from time to assure conformance to specifications. Supplier time) and all other applicable requirements of the FDA and other governmental authorities having jurisdiction. 8.2 All Licensed Products made available for pick up by PPI shall submit two be accompanied by quality control certificates of analysis signed by a duly authorized laboratory official of SANO confirming that each batch of Licensed Product covered by such certificate meets its release Specifications and shall be deemed accepted by it unless PPI, acting reasonably and in good faith, shall give written notice of rejection (unless another number is mutually agreed to) production samples of PRODUCT (hereafter referred to herein collectively as or a "sample(s)Rejection Notice") produced in a continuous run on permanent production tooling to a location designated by Company for examination. Company shall evaluate samples and issue a written acceptance or rejection to Supplier SANO within forty five (45) 35 days after receipt pick up of samples. the Licensed Products by, on behalf of or for the account of PPI at SANO's facility. (a) The failure by Company to reject with cause within such time Rejection Notice shall constitute acceptance. Any rejection shall identify the failure to meet specifications state in reasonable detail (sufficient to allow Supplier enable SANO to correct identify the deficiencynature of the problem and the tests or studies to be conducted by or on its behalf to confirm or dispute same) the reason why the Licensed Products are not acceptable to PPI. If the Licensed Products meet the applicable provisions of Section 8.1 and are in quantities specified in a sample evaluated purchase order, PPI shall not be entitled to reject them. Any Rejection Notice shall be accompanied by copies of all written reports relating to tests, studies or investigations performed to that date by or for PPI on the Licensed Product batch rejected. (b) Upon receipt of such Rejection Notice, SANO may require PPI to return the rejected Licensed Products or samples thereof to SANO for further testing, in which event such Licensed Products or samples thereof, as the case may be, shall be returned by PPI to SANO or at SANO's direction at SANO's expense. If it is later determined by the parties or by an independent laboratory or consultant that PPI was not justified in rejecting the Licensed Products or that PPI or its Affiliates were the cause of or were responsible for the problem, PPI shall reimburse SANO for the costs of the return, as well as any other costs or expenses incurred by SANO as a result of the rejection or return. (c) PPI's test results or basis for rejection shall be conclusive unless SANO notifies PPI, within 30 days of receipt by SANO of the rejected Licensed Products or samples or such longer periods of time as may be reasonable in the circumstances to enable SANO to conduct (and receive the results of) the appropriate tests, studies or investigations which SANO should reasonably conduct to confirm the problem in question and to identify the source thereof, that it disagrees with such test results or its responsibility for the problem in question. In the event of such a notice by SANO, representative samples of the batch of the Licensed Product in question shall be submitted to a mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review, the costs of which shall be paid by the party that is determined by the independent laboratory or consultant to have been responsible for the rejection. (d) If a Licensed Product is rejected by PPI, PPI's duty to pay the amount payable to SANO pursuant to this Section 7.2 hereof in respect of the rejected Licensed Product shall be suspended until such time as it is determined (I) by an independent laboratory or consultant that the Licensed Product in question should not have been rejected by PPI or (II) by the parties or by any arbitration conducted pursuant hereto or by a final order of a court of competent jurisdiction (which is not subject to further appeal) that any act or omission of, on behalf of or for which PPI or its Affiliates is responsible was the cause of the problem that was the basis for the rejection. If only a portion of an order is rejected, Supplier agrees only the duty to correct, at its expense, pay the failure amount allocable to such portion shall be suspended. 8.3 In the event any Licensed Products are appropriately rejected by PPI (being Licensed Products that do not meet the specifications applicable provisions of Section 8.1 other than as a result of any act or omission by PPI or its Affiliates), SANO shall replace such Licensed Products with conforming goods or, if requested by PPI, shall provide a credit to PPI for the amount, if any, previously paid by PPI to SANO on account of the Licensed Products in question. The credit shall be provided by SANO to PPI immediately following the expiry of the period during which SANO may dispute a Rejection Notice as contemplated in Section 8.2(c) above (referred to herein collectively as "defect") leading to unless the Rejection Notice is disputed by SANO, in which event such rejection and resubmit a corrected sample to Company within thirty (30) days after receipt credit shall be given only if the dispute is resolved in favor of notice from Company of such defect (collectively referred to herein as the "Corrective Period"PPI). Company Replacement Licensed Products, as aforesaid, shall have thirty (30) days after be delivered to PPI at no cost to PPI if PPI has already paid for the resubmitting rejected Licensed Products and not received a credit therefor, as aforesaid. All delivery costs, including insurance, incident to the return of Licensed Products to SANO and delivery of the corrected sample replacement Licensed Products to accept or reject such deliverable. If PPI's Spring Valley facility shall be paid by SANO, unless the defects in a rejected sample are rejection is determined not corrected within the Corrective Period or if a resubmitted sample re-tested or re-evaluated by Company during the thirty (30) day re-evaluation period is again to have been appropriately rejected, Company may at its option: (ain which case the last sentence of Section 8.2(a) accept the sample as is; (b) afford Supplier one or more correction extensions; or (c) terminate the applicable SPA and purchase orders issued hereunder without any cost or charge to Company whatsoever, including costs or charges incurred by Supplier in procuring equipment, material and special tooling to perform any part of this Agreement, loss of profits or labor, and materials expended in the production of samples. If Company opts to perform testing at Supplier's facility, Supplier shall allow Company to send a representative(s) to observe and participate in the testing. Supplier shall not make any shipments under this Agreement prior to correction of defects and approval of the production samples. Company will return samples to Supplierapply.

Appears in 1 contract

Samples: Distribution Agreement (Pharmaceutical Resources Inc)

PRODUCT ACCEPTANCE. PRODUCT (a) Cerus has the right to inspect or audit bulk Product after production for integrity and adherence to the Specifications, directly or through its designee. Upon receipt of the Certificate of Analysis (“CoA”) for such bulk Product, Cerus (directly or through its designee) shall promptly conduct a reasonable inspection of such accompanying CoA for quantity and quality conformity. Unless Cerus or its designee notifies Ash Xxxxxxx in writing, within [ * ] from a receipt of a CoA, that it rejects a CoA of Product (a “Notice of Rejection”) for failure to conform to Specifications or failure to have been manufactured in accordance with regulatory requirements, Cerus shall be deemed to have accepted such bulk Product. (b) Cerus has the right to inspect or audit repackaged Product following receipt of a shipment for integrity and adherence to the Specifications, directly or through its designee. Upon receipt of the shipping documentation for such repackaged Product, Cerus (directly or through its designee) shall promptly conduct a reasonable inspection of such shipping documentation for quantity and quality conformity. Unless Cerus or its designee notifies Ash Xxxxxxx in writing, within [ * ] from a receipt of a shipment, that it rejects a shipment of Product (a “Notice of Rejection”) for failure to conform to Specifications or failure to have been manufactured in accordance with regulatory requirements, Cerus shall be deemed to have accepted such Product. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (c) If Cerus rejects any of the Products, it shall promptly notify Ash Xxxxxxx. Upon receipt of a Notice of Rejection, Ash Xxxxxxx shall immediately arrange to receive back the rejected Lot(s) of the Product. Ash Xxxxxxx may, within [ * ] have an agent inspect such goods for non-conformity, otherwise, such inspection shall be made on return of the non-conforming Products to Ash Xxxxxxx. If there is subject a dispute as to Company's acceptance whether any portion of any shipment of the Product is not in compliance, such dispute shall be resolved by having a representative of Ash Xxxxxxx observe the performance of the analytical testing to assure conformance to specificationsby Cerus or Cerus’ designee personnel or by having one of their representatives observe the performance of the analytical testing by Ash Xxxxxxx’ personnel. Supplier If the discrepancy results cannot be resolved in this manner, the testing shall submit two be performed by an independent, mutually acceptable, qualified third party. (unless another number is d) Rework of Product rejected by Cerus will only be performed following a mutually agreed toupon plan. Routine issues that are identified and resolved during manufacturing and product testing will be documented in the Product’s Batch Record and will be approved by Ash Xxxxxxx. All reworked material must meet final release requirements. (e) production samples of PRODUCT (referred to herein collectively as or "sample(s)") produced in a continuous run on permanent production tooling to a location designated by Company for examination. Company shall evaluate samples and issue a written acceptance or rejection to Supplier within forty five (45) days after receipt of samples. The failure by Company to reject with cause within such time shall constitute acceptance. Any rejection shall identify the failure to meet specifications in reasonable detail sufficient to allow Supplier to correct the deficiency. If a sample evaluated pursuant to this Section lot of Product is rejected, Supplier agrees to correctAsh Xxxxxxx will schedule another production run as soon as commercially reasonable thereafter and will deliver a new lot of Product if so requested in writing by Cerus. (f) Unless Ash Xxxxxxx commits unlawful acts during the production, at its expensetesting, the failure to meet the specifications (referred to herein collectively as "defect") leading to such rejection and resubmit a corrected sample to Company within thirty (30) days after receipt of notice from Company of such defect (collectively referred to herein as the "Corrective Period"). Company shall have thirty (30) days after the resubmitting or release of the corrected sample to accept or reject such deliverable. If the defects in a rejected sample are not corrected within the Corrective Period or if a resubmitted sample re-tested or re-evaluated by Company during the thirty (30) day re-evaluation period is again rejectedProduct, Company may at its option: (a) accept the sample as is; (b) afford Supplier one or more correction extensions; or (c) terminate the applicable SPA and purchase orders issued hereunder without any cost or charge to Company whatsoever, including costs or charges incurred by Supplier in procuring equipment, material and special tooling to perform any part all liability of this Agreement, loss of profits or labor, and materials expended in the production of samples. If Company opts to perform testing at Supplier's facility, Supplier Ash Xxxxxxx shall allow Company to send a representative(s) to observe and participate in the testing. Supplier shall not make any shipments under this Agreement prior to correction of defects and approval end upon satisfactory compliance of the production samples. Company will return samples to SupplierProducts with agreed upon specification.

Appears in 1 contract

Samples: Supply Agreement (Cerus Corp)

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