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.

Non-Conforming Products. (a) Vericel may reject If OMP reasonably determines within the Initial Acceptance Testing Period that all or 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 portion of a shipment of Products are non-conformities that are capable conforming with the Specifications, OMP shall provide Triax a notice of detection upon a reasonable visual inspectionnon-conformance and appropriate supporting documentation, and unless Triax disputes such determination in good faith, Triax shall promptly correct the defects identified by OMP or supply new Products within [***] thirty (30) days after receipt of the ACI-Maix-Membrane Products; or (ii) for “latent defects,” meaning those that are not capable OMP's notice of detection upon a reasonable visual inspection, within [***] days from the date of discovery of such non-conformityconformance. Vericel All costs and expenses associated with any such correction or replacement, including, without limitation, transportation charges for return to Triax and subsequent return to OMP, shall inform Matricel be borne solely by Triax. Upon receipt by OMP of corrected or replaced Products, OMP shall have an additional sixty (60) day period to conduct Acceptance Testing ("Additional Acceptance Testing Period"). If during such rejection by providing notice in writing (including via email) and shall return Additional Acceptance Testing Period, OMP determines that any of the Rejected Product to Matricel in accordance Products are still non-conforming 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 Triax shall (unless Triax disputes such determination in good faith) provide new replacement Products for all non-conforming Products at Triax's sole cost and expense and OMP shall have a second Additional Acceptance Testing Period for such replacement Products. If Triax disputes any determination by OMP that [***]the Products do not conform with the Specifications, the Parties shall submit the Products at issue to a mutually-acceptable, independent testing lab, and the report issued by such testing lab shall be final and binding on the Parties. Matricel shall The fees charged by such testing lab will be paid by the Party whose position is not be liable for (I) any incorrect use supported by the report of the ACI-Maix-Membrane CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”testing lab. 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 1934If the testing lab’s report supports the position of OMP, AS AMENDED. Product then Triax shall correct defects or supply new Products as set forth above, provided that the time period for doing so shall end thirty (II30) any use of days after the ACI-Maix-Membrane Product without date on which the legally required approval of parties receive 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 defecttesting lab’s report.

Non-Conforming Products. Dey xxxll have a period of forty-five (a45) 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 receipt of the Products to inspect any shipment of the Products for non-conformance because (i) the Products apparently are Non-Conforming Products or (ii) any act or omission of Meridian known to Dey xxx caused the Products to be Non-Conforming Products. In the event of any such non-conformityconformance, Dey xxxll send a written notice of non-conformance to Meridian within such forty-five (45) day period, which notice shall specify the manner in which such Products are Non-Conforming Products. Vericel Meridian shall inform Matricel have a period of twenty (20) days of the date of receipt of such rejection written notice to inspect such Products. If Meridian disagrees that the Products are Non-Conforming Products, Meridian shall send a written notice to Dey xxxhin such twenty (20) day period, which notice shall specify the nature of Meridian's disagreement with Dey's notice of non- conformance, and the Parties shall meet within ten (10) days of such notice to discuss and attempt in good faith to resolve the matter. If the Parties are unable to resolve the matter within fifteen (15) days after their initial meeting, the Parties shall submit the question of non-conformance to an independent laboratory and/or consultant mutually agreeable to Meridian and Dey xxx resolution and the resolution by providing notice in writing (including via email) and such independent laboratory or consultant shall be binding on both Parties. If the independent laboratory or consultant determines that the Products are Non-Conforming Products, or if Meridian agrees that the Products are Non-Conforming Products, Meridian shall notify Dey xxxther the Non-Conforming Products should be destroyed or returned to Meridian, shall reimburse Dey xxx any costs associated with the destruction or return the Rejected Product to Matricel of Non-Conforming Products in accordance with Matricel’s instructionsSection 6e and shall promptly replace the Non-Conforming Products with conforming Products at no cost to Dey xxxess the Parties agree that Meridian instead will reimburse Dey xxx any amounts paid by Dey xxx such Non-Conforming Products pursuant to Section 5f; provided that should the Parties agree that Meridian will provide reimbursement for rather than replace the Non-Conforming Products, the number of Non-Conforming Products so delivered by Meridian to Dey xxxll count towards Dey's Annual Minimum requirements set forth under Section 2b hereof. In case Dey xxxll not be liable to pay any unpaid invoices relating to such Non-Conforming Products until such Non-Conforming Products have been replaced. If the independent laboratory or consultant determines that the Products were not Non-Conforming Products, Dey xxxll accept the Products; provided that the three month period specified with respect to such Products in Section 4i shall be shortened by a period of time equal to the period from the date of shipment to the date of such determination. Notwithstanding the foregoing, if it is determined at a supply by Matricel of any ACI-Maix-Membrane later date that the Products that is do not in compliance with cGMP or fails to conform to the Specificationsrequirements set forth in Section 3a hereof, then Vericel may choose that [***]. Matricel such Products shall not be liable for (I) any incorrect use of the ACIdeemed Non-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 defectConforming Products.

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) KEY: M = Matricel, V = Vericel 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. 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.