Common use of Non-Conforming Product Clause in Contracts

Non-Conforming Product. Xxxx shall inspect the Product that is delivered by Corium pursuant to this Agreement according to Xxxx’x standard inspection guidelines, prior to their distribution and sale by Xxxx or sublicensees or distributors. If a shipment of Product, or any portion thereof, is from visual inspection adulterated, damaged, defective or otherwise non-conforming, then Xxxx shall have the right to reject such shipment, or the portion thereof that fails to so conform as the case may be, upon written notice to Corium, specifying the grounds for such rejection, within [*] following the date on which Xxxx receives from Corium the invoice relating to such shipment of Product. If no notice of rejection is given by Xxxx within such [*] period or with respect to a shipment of Product, then such shipment shall be deemed to have been accepted; provided, however, that any failure to provide a notice of rejection by Xxxx shall not be deemed to be an acceptance in the event that any reason for rejection exists that could not be discovered during a reasonable inspection of such shipment in which case Xxxx shall have the right to reject the shipment within [*] of the discovery of such latent defect, but in no event later than [*] following the date on which Xxxx receives from Corium the invoice relating to such shipment of Product. For the avoidance of doubt, Xxxx shall have no obligation to inspect any shipment beyond ordinary visual inspection. In the event of any rejection pursuant to this Section 8.8, [*]. If Corium agrees with Xxxx’x claim, [*]. If Xxxx and Corium are unable to resolve their differences, then either Xxxx or Corium may refer the matter to a certified analytical firm of international reputation independent of and acceptable to both Parties for final analysis using a sample from such shipment provided by Xxxx, which shall be binding on Xxxx and *Confidential Treatment Requested.

Appears in 4 contracts

Samples: And Commercialization Agreement, And Commercialization Agreement (Corium International, Inc.), And Commercialization Agreement (Corium International, Inc.)

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Non-Conforming Product. Xxxx shall inspect the Product Products that is are delivered by Corium pursuant to this Agreement according to Xxxx’x standard inspection guidelines, prior to their distribution and sale by Xxxx or sublicensees or distributors. If a shipment of ProductProducts, or any portion thereof, is from visual inspection adulterated, damaged, defective or otherwise non-conforming, then Xxxx shall have the right to reject such shipment, or the portion thereof that fails to so conform conform, as the case may be, upon written notice to Corium, specifying the grounds for such rejection, within [*] following the date on which Xxxx receives from Corium the invoice relating to such shipment of ProductProducts. If no notice of rejection is given by Xxxx within such [*] period or with respect to a shipment of ProductProducts, then such shipment shall be deemed to have been accepted; provided, however, that any failure to provide a notice of rejection by Xxxx shall not be deemed to be an acceptance in the event that any reason for rejection exists that could not be discovered during a reasonable inspection of such shipment in which case Xxxx shall have the right to reject the shipment within [*] of the discovery of such latent defect, but in no event later than [*] following the date on which Xxxx receives from Corium the invoice relating to such shipment of Product. For the avoidance of doubt, Xxxx shall have no obligation to inspect any shipment beyond ordinary visual inspectionshipment. In the event of any rejection pursuant to this Section 8.8, such rejection[*]. If Corium agrees with Xxxx’x claim, [*]. If Xxxx and Corium are unable to resolve their differences, then either Xxxx or Corium may refer the matter to a certified analytical firm of international reputation independent of and acceptable to both Parties for final analysis using a sample from such shipment provided by Xxxx, which shall be binding on Xxxx and *Confidential Treatment RequestedCorium. The fees and disbursements of such firm shall be paid by the Party whose contention is rejected by the firm.

Appears in 4 contracts

Samples: And Commercialization Agreement, And Commercialization Agreement (Corium International, Inc.), And Commercialization Agreement (Corium International, Inc.)

Non-Conforming Product. Xxxx shall inspect the Product that is delivered by Corium pursuant to this Agreement according to Xxxx’x standard inspection guidelines, prior to their distribution and sale by Xxxx or sublicensees or distributors. If a shipment of Product, or any portion thereof, is from visual inspection adulterated, damaged, defective or otherwise non-conforming, then Xxxx Celsion shall have the right, at its sole discretion and at its cost and expense, to inspect and test any and all Product delivered to it hereunder to determine whether such Product complies with the Specifications. Compliance verification may include but is not limited to on-site inspections, environmental monitoring program reviews, employee training and methods analysis, batch record reviews, controlled document maintenance assessment, analytical and physical analysis, among other commonly used means to assess Product Quality. Celsion will use validated methods to test the Product. Celsion will notify Hisun in writing [***] after delivery thereof if it rejects any Product delivered or to be delivered because such Product failed to meet the Specifications, quality practices (GMP), or does provide sufficient documented assurances of a Quality environment. If Celsion rejects any Product, Hisun and Celsion will conduct a joint investigation to determine the cause of the defect or system failure. In the event of a specification failure, Hisun shall have the right, at its request, to conduct its own tests on such rejected Product. Product not rejected within [***] will be deemed accepted and will constitute a waiver of any claims Celsion may have against Hisun with respect to payment for such shipment subject, however, to Celsion’s right to reject any Product for Latent Defects discovered by Celsion and return such shipment, or the portion thereof that fails Product to so conform as the case may be, upon written notice to Corium, specifying the grounds for such rejection, within Hisun with [*] following **]of the date on identification of such Latent Defect by Celsion. Hisun will replace any properly rejected Product with Product which Xxxx receives from Corium meets the invoice relating Specifications within a commercially reasonable time and will deliver such replacement Product to Celsion, at Hisun’s sole cost and expense. In addition, Hisun will, at Hisun’s sole cost and expense, arrange for all such shipment rejected Product to be picked up promptly and, where applicable, destroyed in accordance with all Applicable Laws. Celsion will have no responsibility to Hisun for the Purchase Price of Product. If no notice of rejection is given by Xxxx within such [*] period or with respect to a shipment of nonconforming Product, then such shipment shall be deemed to have been acceptedbut will pay Hisun the Purchase Price for the replacement Product in accordance with Section 3.1 above; provided, however, that any failure to provide the extent Celsion previously paid for Product it properly rejected in accordance with this Section 4.5.1, Celsion will receive a notice of rejection by Xxxx shall credit against the Purchase Price for the replacement Product. Product properly rejected in accordance with this Section 4.5 will not be deemed applied to be an acceptance Celsion’s purchase commitment set forth in the event that any reason for rejection exists that could not be discovered during a reasonable inspection of such shipment in which case Xxxx shall have the right to reject the shipment within [*] of the discovery of such latent defectSection 4.1, but in no event later than [replacement Product will be so applied. *] following **Text Omitted and Filed Separately with the date on which Xxxx receives from Corium the invoice relating to such shipment of ProductSecurities and Exchange Commission. For the avoidance of doubt, Xxxx shall have no obligation to inspect any shipment beyond ordinary visual inspection. In the event of any rejection pursuant to this Section 8.8, [*]. If Corium agrees with Xxxx’x claim, [*]. If Xxxx and Corium are unable to resolve their differences, then either Xxxx or Corium may refer the matter to a certified analytical firm of international reputation independent of and acceptable to both Parties for final analysis using a sample from such shipment provided by Xxxx, which shall be binding on Xxxx and *Confidential Treatment Requested.Requested Under

Appears in 1 contract

Samples: Technology Development Agreement (Celsion CORP)

Non-Conforming Product. Xxxx (i) Purchaser or its designee shall inspect perform the acceptance tests set forth in the Specifications after each delivery of Product hereunder; provided however, that is delivered neither a failure to conduct such acceptance testing nor any such acceptance testing results that indicate Product conformity shall have any bearing on any of Manufacturer’s representations, warranties or Manufacturing obligations. In the event that Purchaser determines, within thirty (30) days after delivery thereof by Corium pursuant to this Agreement according to Xxxx’x standard inspection guidelines, prior to their distribution and sale by Xxxx Manufacturer (or sublicensees or distributors. If a shipment within fourteen (14) days after discovery of Product, or any portion thereof, is from visual inspection adulterated, damaged, defective or otherwise non-conformingconformity that could not reasonably have been detected by such acceptance testing), that any Product supplied by Manufacturer does not conform to the warranties set forth in Sections 2.2(f)(i), (ii) or (vi), then Xxxx Purchaser shall have give Manufacturer Notice of rejection of non-conforming Product. Purchaser shall set forth in each such notification the right to reject such shipment, or the portion thereof that fails to so conform as the case may be, upon written notice to Corium, specifying the grounds basis for such rejection, including any testing or inspection results. Manufacturer shall undertake appropriate evaluation and shall notify Purchaser whether it has confirmed such nonconformity within [*] following the date on which Xxxx receives thirty (30) days after receipt of such Notice from Corium the invoice relating to such shipment of ProductPurchaser. If no notice of rejection is given by Xxxx within Manufacturer notifies Purchaser that it has not confirmed such [*] period nonconformity, the Parties shall submit the dispute to an independent testing laboratory or other appropriate expert mutually acceptable to the Parties (the “Testing Laboratory”) for evaluation. Both Parties shall cooperate with respect to a shipment of Product, then such shipment shall be deemed to have been accepted; provided, however, that any failure to provide a notice of rejection by Xxxx shall not be deemed to be an acceptance the Testing Laboratory’s reasonable requests for assistance in the event that any reason for rejection exists that could not be discovered during a reasonable inspection of such shipment in which case Xxxx shall have the right to reject the shipment within [*] connection with its evaluation hereunder. The findings of the discovery of such latent defect, but in no event later than [*] following the date on which Xxxx receives from Corium the invoice relating to such shipment of Product. For the avoidance of doubt, Xxxx shall have no obligation to inspect any shipment beyond ordinary visual inspection. In the event of any rejection pursuant to this Section 8.8, [*]. If Corium agrees with Xxxx’x claim, [*]. If Xxxx and Corium are unable to resolve their differences, then either Xxxx or Corium may refer the matter to a certified analytical firm of international reputation independent of and acceptable to both Parties for final analysis using a sample from such shipment provided by Xxxx, which Testing Laboratory shall be binding on Xxxx the Parties, absent manifest error. The expenses of the Testing Laboratory shall be borne by Manufacturer if the testing confirms the non-conformity and *Confidential Treatment Requestedotherwise by Purchaser. If the Testing Laboratory or Manufacturer confirms that Product does not conform to the warranties set forth in Sections 2.2(f)(i), (ii) or (vi), and Purchaser either returns such non-conforming Product to Manufacturer or provides to Manufacturer written Notice with documentation to the effect that such non-conforming Product has been destroyed in accordance with applicable Law, upon mutual agreement of the Parties, Manufacturer promptly shall (i) supply Purchaser with a conforming quantity of Product at Manufacturer’s expense; or (ii) reimburse Purchaser for the Purchase Price paid by Purchaser with respect to such non- conforming Product if already paid. In addition, the Parties shall mutually agree as to the reimbursement by Manufacturer of any actual out-of-pocket costs incurred by Purchaser with respect to such non-conforming Product, including costs of recalls, field alerts, field corrections and market withdrawals of Product, including associated retrieval of Product, returns of Product, destruction of Product, replacement of Product, and fees and penalties owed to Third Parties.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (AbbVie Inc.)

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Non-Conforming Product. Xxxx (i) Licensee shall inspect the all shipments of Product promptly upon receipt, and shall notify Exelixis in writing in reasonable detail within [ * ] of receipt if Licensee is rejecting any Product that is delivered fails to conform to Exelixis’ warranties set forth in Sections 8.2(a) or 8.2(b). All Product not rejected within such [ * ] period will be deemed accepted. [ * ] = Certain confidential information contained in this document, marked by Corium brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to this Agreement according to Xxxx’x standard inspection guidelinesRule 24b-2 of the Securities Exchange Act of 1934, prior to their distribution and sale by Xxxx or sublicensees or distributorsas amended. (ii) If a shipment Licensee notifies Exelixis of Productany nonconformity of any Product in accordance with Section 2.5(b)(i), or any portion thereof, is from visual inspection adulterated, damaged, defective or otherwise non-conforming, then Xxxx Exelixis shall have the right to reject inspect the Product in question and Licensee shall cooperate with Exelixis’ inspection, including providing Exelixis with samples of the Product in question for testing upon request. If Exelixis agrees with such shipmentnotice of nonconformity, Exelixis shall, at its discretion and expense, either: (i) replace such Product, at no additional expense to Licensee, as soon as reasonably practicable after receipt of notification of such nonconformity or (ii) refund any portion of the applicable Transfer Price that has already been paid. (iii)In the event that Exelixis disagrees with Licensee that a Product does not conform to Exelixis’ warranties set forth in Sections 8.2(a) or 8.2(b), or considers that the portion thereof that fails defect was caused by occurrences after the delivery of the Product to so conform Licensee, it may require a sample of the allegedly nonconforming Product to be delivered to a mutually acceptable independent testing laboratory for testing or, in the case of a dispute concerning compliance with GMP, an independent consultant for evaluation. Except in the case of manifest error, the determination of the laboratory or consultant as to whether the Product is nonconforming will be final and binding on the Parties. The fees and expenses of such laboratory testing or consultant, as the case may be, upon written notice to Coriumshall be borne entirely by the Party against whom such laboratory’s or consultant’s determination is made. If, specifying as the grounds case may be, such determination is against Exelixis, then Exelixis shall either refund the Transfer Price paid by Licensee for such rejection, within [*] following the date on which Xxxx receives from Corium the invoice relating to Product or replace such shipment of Product. If no notice of rejection is given by Xxxx within such [*] period or with respect to a shipment of Product, then such shipment shall be deemed at no additional cost to have been accepted; providedLicensee, however, that any failure to provide a notice of rejection by Xxxx shall not be deemed to be an acceptance in the event that any reason for rejection exists that could not be discovered during a reasonable inspection of such shipment in which case Xxxx shall have the right to reject the shipment within [*] of the discovery of such latent defectas soon as reasonably possible, but in no event later than [*[ * ] following if replacement Product stock is available, or if replacement Product stock is unavailable at such time, as soon as reasonably practical after it becomes available. If, as the date on which Xxxx receives from Corium the invoice relating to case may be, such shipment of Product. For the avoidance of doubt, Xxxx shall have no obligation to inspect any shipment beyond ordinary visual inspection. In the event of any rejection pursuant to this Section 8.8, [*]. If Corium agrees with Xxxx’x claim, [*]. If Xxxx and Corium are unable to resolve their differencesdetermination is against Licensee, then either Xxxx or Corium may refer the matter to a certified analytical firm of international reputation independent of and acceptable to both Parties for final analysis using a sample from such shipment provided by Xxxx, which Product shall be binding on Xxxx and *Confidential Treatment Requested.deemed accepted by Licensee. (c)

Appears in 1 contract

Samples: Supply Agreement

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