Common use of Remedies for Non-Conforming Product Clause in Contracts

Remedies for Non-Conforming Product. 5.4.1 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, a Batch of Product materially fails to conform to the Product Warranties due to the failure of: (a) LWI to properly execute the Master Production Record in respect of the manufacture of the Product, (b) LWI to comply with cGMP, (c) LWI’s negligence or willful misconduct, or (d) LWI facilities or utilities then, at CLIENT’s request, LWI will promptly produce for CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT. If the CLIENT has not yet paid for the failed Batch of Product, then CLIENT will be billed when it receives the replacement. 5.4.2 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties for any reason other than as set forth in Section 5.4.1, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense. 5.4.3 After the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties and such failure is (a) not the result of an inherent characteristic of the Process, Materials, or CLIENT Development Materials, including any cell lines originally provided by CLIENT, or (b) not the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, LWI will produce for CLIENT as soon as practicable a Production Rerun, in accordance with the provisions of this Agreement and at no additional cost to CLIENT. 5.4.4 After the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties as a result of (i) an inherent characteristic of the Process, Materials, or CLIENT Development Materials, including any of the cell lines originally provided by CLIENT, or (ii) a failure that is the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense. 5.4.5 Except with respect to [ * ], CLIENT [ * ], and in furtherance thereof, [ * ]. 5.4.6 Each Party will promptly notify the other in the event that it becomes aware of any circumstance that might be reasonably expected to result in a Product recall or market withdrawal. In the event that the CLIENT determines that a recall or market withdrawal of Product is needed, CLIENT shall manage and lead such recall or withdrawal and LWI shall fully cooperate with CLIENT in connection therewith. The administrative costs of a recall or withdrawal will be borne by CLIENT except to the extent that the recall or withdrawal is the result of a negligent or willful act or omission of LWI.

Remedies for Non-Conforming Product. 5.4.1 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in 3.4.1 In the event that the Parties agree, or an independent testing laboratory or experts determinearbitrator if applicable determines, pursuant to Section 5.33.3, that a cGMP Batch of Product materially fails to conform to the Product Warranties (in a manner that the Product can’t be used for the treatment), or Product and/or Materials are destroyed or damaged by LONZA Personnel, due to the failure ofto: (a) LWI the failure of LONZA personnel properly to properly execute the Master Production Record in respect of the manufacture of the Product, Project Documentation; (b) LWI the failure of LONZA personnel to comply with cGMP, cGMP or (c) LWI’s the negligence or willful misconductmisconduct of LONZA or LONZA personnel, or (d) LWI facilities or utilities then, at CLIENTGAMIDA’s request, LWI LONZA will promptly either (i) (at GAMIDA’s discretion), as soon as it is commercially practicable to do so, produce [*] for CLIENT GAMIDA sufficient quantities of Product to replace the non-conforming conforming, portion of such cGMP Batch of Product (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT. If GAMIDA, or (ii) refund the CLIENT has not yet paid for cost of the failed original Batch of Product, then CLIENT such refund shall include the cost of the applicable [*], which shall be calculated as [*], provided, however that in case Product and/or Materials are destroyed or damaged due to negligence of LONZA Personnel (excluding gross negligence or willful misconduct) the [*] will be billed when it receives the replacementequally split between both Parties. 5.4.2 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in 3.4.2 In the event that the Parties agree, or an independent testing laboratory or experts determinedetermines, pursuant to Section 5.33.3, that a cGMP Batch of Product materially fails to conform to the Product Warranties Warranties, or Product and/or Materials are destroyed or damaged by LONZA Personnel, for any reason other than as set forth in Section 5.4.13.4.1, then LWI shall have no liability to CLIENT [*] with respect to such Batch and LWI willcGMP Batch, Product or Material. Notwithstanding anything to the contrary set forth in Section 3.4, if during the manufacture of Product pursuant to this Agreement, Product or Materials are destroyed or damaged by LONZA Personnel while LONZA Personnel were acting at CLIENT’s requestthe written direction of GAMIDA Personnel, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expensethen [*]. 5.4.3 After 3.4.3 GAMIDA acknowledges and agrees that, other than as set forth in Section 13.1 and except for any failure under 3.4.1(a) - (c), its sole remedy with respect to [*], is as set forth in this Section 3.4, and in furtherance thereof, GAMIDA hereby waives all other remedies at law or in equity regarding the Process is submitted as part of a biologic license application foregoing claims. Notwithstanding the foregoing and once it is approved by the FDAsubject to Section 15.2 below, in the event that the Parties agree, of (a) [*] failure rate (or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch more) of Product materially fails Products to conform to the Product Warranties and (including due to Product and/or Materials destroyed or damaged by LONZA Personnel under Section 3.4.1 above) with respect to any calendar year following Commencement Date provided that such failure is (a) not the result of an inherent characteristic of the Process, Materials, or CLIENT Development Materials, including any cell lines originally provided by CLIENT, failures were caused due to LONZA’s fault; or (b) not the result [*] failure rate (or more) of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, LWI will produce for CLIENT as soon as practicable a Production Rerun, in accordance with the provisions of this Agreement and at no additional cost to CLIENT. 5.4.4 After the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails Products to conform to the Product Warranties as a result of with respect to any calendar year following Commencement Date (including due to Product and/or Materials destroyed or damaged by LONZA Personnel under Section 3.4.1 above), provided that (i) an inherent characteristic the termination right as set forth below will not apply with respect to [*] if the failure rate at the end of [*] following the Processapplicable year is [*], Materials, or CLIENT Development Materials, including any of the cell lines originally provided by CLIENT, or and (ii) the above failures were caused due to LONZA’s fault; or (c) unplanned shutdown of any Suite due to LONZA’s fault for a period of more than [*], and such shutdown doesn’t terminate within [*], then GAMIDA may terminate this Agreement [*]. With respect to each failure there will be a root cause study in order to decide what is the cause of the failure and whether the failure is due to LONZA’s fault, if no conclusion can be made then the root cause shall be decided by the JSC and if the JSC fails to reach an agreement it will be escalated to the [*]. In the case the Parties cannot come to an agreement in regards to the root cause, however, agree to a settlement resulting in a credit with regard to the failed Batch, this result will not be counted as a as a failure that is the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT the failure rate of [*] as soon as practicable a Production Rerun at CLIENT’s expenseset forth above. 5.4.5 Except with respect to [ * ], CLIENT [ * ], and in furtherance thereof, [ * ]. 5.4.6 Each Party will promptly notify the other in the event that it becomes aware of any circumstance that might be reasonably expected to result in a Product recall or market withdrawal. In the event that the CLIENT determines that a recall or market withdrawal of Product is needed, CLIENT shall manage and lead such recall or withdrawal and LWI shall fully cooperate with CLIENT in connection therewith. The administrative costs of a recall or withdrawal will be borne by CLIENT except to the extent that the recall or withdrawal is the result of a negligent or willful act or omission of LWI.

Remedies for Non-Conforming Product. 5.4.1 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in In the event that the Parties agree, or an independent testing laboratory or experts determinearbitrator, as applicable, determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties (for clarity, CLIENT’s inability to use such Batch caused by non-conformance with the Product Warranties as determined by an independent testing laboratory or an arbitrator, as applicable, of Product shall be deemed, inter alia, a material failure) due to the failure of: (a) LWI personnel properly to properly execute the Master Production Record in respect of the manufacture of the ProductRecord, (b) LWI personnel to comply with cGMP, or (c) LWI’s negligence or willful misconductthe Facility utilities, or (d) LWI facilities or utilities then, at CLIENT’s request, LWI will promptly produce for CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product or provide another Batch of Product in accordance with CLIENT’s reasonable request (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT. If the ; provided, however, CLIENT has not yet shall have first paid for the failed original Batch of Product, then CLIENT will be billed when it receives the replacement. 5.4.2 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in In the event that the Parties agree, or an independent testing laboratory or experts determinedetermines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties for any reason other than as set forth in Section 5.4.1, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense. 5.4.3 After CLIENT acknowledges and agrees that its sole remedy with respect to the Process failure of Product to conform with any of the Product Warranties (except to the extent such failure is submitted caused due to LWI’s gross negligence or willful misconduct) are (i) as part of a biologic license application set forth in this Section 5.4, and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, (ii) when [*] Production Reruns are produced (pursuant to Section 5.35.4.1), that a Batch of Product and the [*] Production Rerun materially fails to conform to the Product Warranties and such failure is due to: (a) not LWI personnel to properly execute the result of an inherent characteristic of the ProcessMaster Production Record, Materials, or CLIENT Development Materials, including any cell lines originally provided by CLIENT(b) LWI personnel to comply with cGMP, or (bc) not the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractorsFacility utilities, LWI will produce for then CLIENT as soon as practicable a Production Rerun, in accordance with the provisions of may terminate this Agreement and at no additional cost to CLIENT. 5.4.4 After the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties as a result of (i) an inherent characteristic of the Process, Materials, or CLIENT Development Materials, including any of the cell lines originally provided by CLIENT, or (ii) a failure that is the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense. 5.4.5 Except with respect to [ * ], CLIENT [ * [*], and in furtherance thereof, [ * ]. 5.4.6 Each Party will promptly notify CLIENT hereby waives all other remedies at law or in equity regarding the other foregoing claims. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the event that it becomes aware Securities and Exchange Commission pursuant to Rule 406 of any circumstance that might be reasonably expected to result in a Product recall or market withdrawalthe Securities Act of 1933, as amended. In the event that the CLIENT determines that a recall or market withdrawal of Product is needed, CLIENT shall manage Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and lead such recall or withdrawal and LWI shall fully cooperate with CLIENT in connection therewith. The administrative costs of a recall or withdrawal will be borne by CLIENT except to the extent that the recall or withdrawal is the result of a negligent or willful act or omission of LWI.230.406

Remedies for Non-Conforming Product. 5.4.1 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in In the event that the Parties agree, or an independent testing laboratory or experts determinearbitrator, as applicable, determines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties (for clarity, CLIENT’s inability to use such Batch caused by non-conformance with the Product Warranties as determined by an independent testing laboratory or an arbitrator, as applicable, of Product shall be deemed, inter alia, a material failure) due to the failure of: (a) LWI personnel properly to properly execute the Master Production Record in respect of the manufacture of the ProductRecord, (b) LWI personnel to comply with cGMP, or (c) LWI’s negligence or willful misconductthe Facility utilities, or (d) LWI facilities or utilities then, at CLIENT’s request, LWI will promptly produce for CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product or provide another Batch of Product in accordance with CLIENT’s reasonable request (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT. If the ; provided, however, CLIENT has not yet shall have first paid for the failed original Batch of Product, then CLIENT will be billed when it receives the replacement. 5.4.2 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in In the event that the Parties agree, or an independent testing laboratory or experts determinedetermines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties for any reason other than as set forth in Section 5.4.1, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense. 5.4.3 After CLIENT acknowledges and agrees that its sole remedy with respect to the Process failure of Product to conform with any of the Product Warranties (except to the extent such failure is submitted caused due to LWI’s gross negligence or willful misconduct) are (i) as part of a biologic license application set forth in this Section 5.4, and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, (ii) when [*] Production Reruns are produced (pursuant to Section 5.35.4.1), that a Batch of Product and the [*] Production Rerun materially fails to conform to the Product Warranties and such failure is due to: (a) not LWI personnel to properly execute the result of an inherent characteristic of the ProcessMaster Production Record, Materials, or CLIENT Development Materials, including any cell lines originally provided by CLIENT(b) LWI personnel to comply with cGMP, or (bc) not the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractorsFacility utilities, LWI will produce for then CLIENT as soon as practicable a Production Rerun, in accordance with the provisions of may terminate this Agreement and at no additional cost to CLIENT. 5.4.4 After the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties as a result of (i) an inherent characteristic of the Process, Materials, or CLIENT Development Materials, including any of the cell lines originally provided by CLIENT, or (ii) a failure that is the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense. 5.4.5 Except with respect to [ * ], CLIENT [ * [*], and in furtherance thereof, [ * ]CLIENT hereby waives all other remedies at law or in equity regarding the foregoing claims. 5.4.6 Each Party will promptly notify the other in the event that it becomes aware of any circumstance that might be reasonably expected to result in a Product recall or market withdrawal. In the event that the CLIENT determines that a recall or market withdrawal of Product is needed, CLIENT shall manage and lead such recall or withdrawal and LWI shall fully cooperate with CLIENT in connection therewith. The administrative costs of a recall or withdrawal will be borne by CLIENT except to the extent that the recall or withdrawal is the result of a negligent or willful act or omission of LWI.

Remedies for Non-Conforming Product. 5.4.1 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in In the event that the Parties agree, or an independent testing laboratory or experts determinedetermines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties due to the failure of: (a) LWI XXXX personnel properly to properly execute the Master Production Record in respect of the manufacture of the ProductRecord, (b) LWI XXXX personnel to comply with cGMP, or (c) LWI’s negligence or willful misconductthe Facility utilities, or (d) LWI facilities or utilities then, at CLIENT’s request, LWI XXXX will promptly produce for CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT. XXXX shall complete any Production Rerun as soon as possible following CLIENT’s request therefore and in any event within 60 days of such request. If more than 25% of the Batches of a Product ordered by CLIENT has for delivery during any 12 month period in which CLIENT orders more than 20 Batches, fails to conform to the Product Warranties due to the failure of (a), (b) or (c) and XXXX cannot yet paid for cure the failed Batch cause(s) of Productsuch failures within sixty (60) days of notice thereof, then CLIENT will the Minimum Purchase Obligation relating to such Product shall be billed when it receives the replacementof no further force and effect. 5.4.2 Until the Process is submitted as part of a biologic license application and is approved by the FDA, in In the event that the Parties agree, or an independent testing laboratory or experts determinedetermines, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties for any reason other than as set forth in Section 5.4.1, then LWI XXXX shall have no liability to CLIENT with respect to such Batch and LWI XXXX will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense. 5.4.3 After CLIENT acknowledges and agrees that its sole remedy with respect to the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch failure of Product materially fails to conform to with any of the Product Warranties and such failure is (a) not the result of an inherent characteristic of the Process, Materials, or CLIENT Development Materials, including any cell lines originally provided by CLIENT, or (b) not the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, LWI will produce for CLIENT as soon as practicable a Production Rerun, set forth in accordance with the provisions of this Agreement and at no additional cost to CLIENT. 5.4.4 After the Process is submitted as part of a biologic license application and once it is approved by the FDA, in the event that the Parties agree, or an independent testing laboratory or experts determine, pursuant to Section 5.3, that a Batch of Product materially fails to conform to the Product Warranties as a result of (i) an inherent characteristic of the Process, Materials, or CLIENT Development Materials, including any of the cell lines originally provided by CLIENT, or (ii) a failure that is the result of circumstances outside of LWI’s reasonable control or the control of its Affiliates or permitted contractors, then LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT as soon as practicable a Production Rerun at CLIENT’s expense. 5.4.5 Except with respect to [ * ], CLIENT [ * ]5.4, and in furtherance thereof, [ * ]Client hereby waives all other remedies at law or in equity regarding the foregoing claims. 5.4.6 Each Party will promptly notify the other in the event that it becomes aware of any circumstance that might be reasonably expected to result in a Product recall or market withdrawal. In the event that the CLIENT determines that a recall or market withdrawal of Product is needed, CLIENT shall manage and lead such recall or withdrawal and LWI shall fully cooperate with CLIENT in connection therewith. The administrative costs of a recall or withdrawal will be borne by CLIENT except to the extent that the recall or withdrawal is the result of a negligent or willful act or omission of LWI.