Common use of Non-Conforming Products Clause in Contracts

Non-Conforming Products. (a) Vericel may reject any ACI-Maix-Membrane Product that is not in compliance with cGMP or fails to conform to the Specifications (“Rejected Products”) (i) for “apparent defects,” meaning those non-conformities that are capable of detection upon a reasonable visual inspection, within [***] days after receipt of the ACI-Maix-Membrane Products; or (ii) for “latent defects,” meaning those that are not capable of detection upon a reasonable visual inspection, within [***] days from the date of discovery of such non-conformity. Vericel shall inform Matricel of such rejection by providing notice in writing (including via email) and shall return the Rejected Product to Matricel in accordance with Matricel’s instructions. In case of a supply by Matricel of any ACI-Maix-Membrane Products that is not in compliance with cGMP or fails to conform to the Specifications, then Vericel may choose that [***]. Matricel shall not be liable for (I) any incorrect use of the ACI-Maix-Membrane CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Product or (II) any use of the ACI-Maix-Membrane Product without the legally required approval of the Final Product by Vericel, or a Vericel customer. ACI-Maix-Membrane Products that comply with the Specifications but do not comply with the Minimum Acceptable Surface Area After Hydration shall not be regarded as a material defect. (b) Section 377 of the German Commercial Code (Handelsgesetzbuch) is expressly excluded and replaced by the provisions of this Agreement and the Quality Service Agreement.

Non-Conforming Products. (a) Vericel may reject Endo shall promptly conduct an inspection of the Products delivered by SkyePharma for any ACI-Maix-Membrane visual defect or damage after Endo’s receipt of such Product and all associated quality assurance documents, including, without limitation, the certificate of analysis. Endo shall have *** upon such receipt to give SkyePharma written notice of rejection of such shipment of Products to the extent Endo determines that is not the Products fail to conform with any warranty or Specifications set forth herein following its visual inspection. Any rejection notice given hereunder shall specify the manner in compliance with cGMP or which the Product fails to conform to the Specifications (“Rejected Products”) (i) for “apparent defects,” meaning those non-conformities that are capable of detection upon a reasonable visual inspection, within [***] days after receipt of the ACI-Maix-Membrane Products; meet such warranty or (ii) for “latent defects,” meaning those that are not capable of detection upon a reasonable visual inspection, within [***] days from the date of discovery of such non-conformity. Vericel shall inform Matricel of such rejection by providing notice in writing (including via email) and shall return the Rejected Product to Matricel in accordance with Matricel’s instructions. In case of a supply by Matricel of any ACI-Maix-Membrane Products that is not in compliance with cGMP or fails to conform to the Specifications, then Vericel may choose that [***]. Matricel shall not be liable for (I) any incorrect use of the ACI-Maix-Membrane CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Product or (II) any use of the ACI-Maix-Membrane Product without the legally required approval of the Final Product by Vericel, or a Vericel customer. ACI-Maix-Membrane Products that comply with the Specifications but do not comply with the Minimum Acceptable Surface Area After Hydration shall not be regarded as a material defect. (b) Section 377 If it is determined by agreement of the German Commercial Code Parties (Handelsgesetzbuch) is expressly excluded and replaced by or in the provisions absence of this Agreement and agreement of the Parties, in accordance with the dispute resolution set forth in Article IX of the Quality Service Agreement) that the Product is non-conforming, then SkyePharma shall credit Endo’s account for the price invoiced for such non-conforming Product, together with all out-of-pocket expenses (including, without limitation, all shipping and insurance charges) associated with the purchase and return of the Product. If payment therefor has previously been made by Endo, SkyePharma shall, at Endo’s option, (x) pay Endo the amount of such credit, (y) offset the amount thereof against other amounts then due SkyePharma hereunder, or (z) replace such nonconforming Product with conforming Product at no additional cost to Endo. (c) Except as set forth in 13.2, if Endo does not provide SkyePharma with any written notice of rejection within such *** period, Endo shall be deemed to have accepted and released the Product.

Non-Conforming Products. (a) Vericel may reject Endo shall promptly conduct an inspection of the Products delivered by SkyePharma for any ACI-Maix-Membrane visual defect or damage after Endo's receipt of such Product and all associated quality assurance documents, including, without limitation, the certificate of analysis. Endo shall have [Confidential Information Has Been Omitted And Furnished Separately To The Securities And Exchange Commission] upon such receipt to give SkyePharma written notice of rejection of such shipment of Products to the extent Endo determines that is not the Products fail to conform with any warranty or Specifications set forth herein following its visual inspection. Any rejection notice given hereunder shall specify the manner in compliance with cGMP or which the Product fails to conform to the Specifications (“Rejected Products”) (i) for “apparent defects,” meaning those non-conformities that are capable of detection upon a reasonable visual inspection, within [***] days after receipt of the ACI-Maix-Membrane Products; meet such warranty or (ii) for “latent defects,” meaning those that are not capable of detection upon a reasonable visual inspection, within [***] days from the date of discovery of such non-conformity. Vericel shall inform Matricel of such rejection by providing notice in writing (including via email) and shall return the Rejected Product to Matricel in accordance with Matricel’s instructions. In case of a supply by Matricel of any ACI-Maix-Membrane Products that is not in compliance with cGMP or fails to conform to the Specifications, then Vericel may choose that [***]. Matricel shall not be liable for (I) any incorrect use of the ACI-Maix-Membrane CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Product or (II) any use of the ACI-Maix-Membrane Product without the legally required approval of the Final Product by Vericel, or a Vericel customer. ACI-Maix-Membrane Products that comply with the Specifications but do not comply with the Minimum Acceptable Surface Area After Hydration shall not be regarded as a material defect. (b) Section 377 If it is determined by agreement of the German Commercial Code Parties (Handelsgesetzbuch) is expressly excluded and replaced by or in the provisions absence of this Agreement and agreement of the Parties, in accordance with the dispute resolution set forth in Article IX of the Quality Service Agreement) that the Product is non-conforming, then SkyePharma shall credit Endo's account for the price invoiced for such non-conforming Product, together with all out-of-pocket expenses (including, without limitation, all shipping and insurance charges) associated with the purchase and return of the Product. If payment therefor has previously been made by Endo, SkyePharma shall, at Endo's option, (x) pay Endo the amount of such credit, (y) offset the amount thereof against other amounts then due SkyePharma hereunder, or (z) replace such nonconforming Product with conforming Product at no additional cost to Endo. (c) Except as set forth in 13.2, if Endo does not provide SkyePharma with any written notice of rejection within such [Confidential Information Has Been Omitted And Furnished Separately To The Securities And Exchange Commission] period, Endo shall be deemed to have accepted and released the Product.