Common use of Supply Failure Clause in Contracts

Supply Failure. In the event that: (i) the Facility fails an inspection or suffers a hold or disciplinary action by the FDA or any other government authority that prevents CPL from Delivering Product and CPL fails to cure such inspection shortcoming, or remove or resolve such hold or disciplinary action in such a manner that the Facility passes re-inspection by the FDA or applicable government authority and/or is free of the hold or disciplinary action, in good standing with FDA or such other applicable government authority, and is lawfully able to and does resume timely and conforming manufacture and delivery of OptiNose’s Product requirements in accordance with this Agreement within [***] ([***]) days of such original inspection, or imposition of the hold or disciplinary action; (ii) CPL materially breaches obligations or requirements under this Agreement related to the Manufacture and Delivery of the Product as set forth herein and fails to cure such breach within [***] ([***]) days of notice thereof by OptiNose, provided, however, that such [***] ([***]) day cure period shall be extended by up to an additional [***] ([***]) days if such breach is reasonably curable within such period and if CPL is diligently working to cure such breach as soon as practicable; (iii) a Force Majeure preventing CPL from effecting timely Manufacture and/or Delivery of OptiNose’s requirements of Product endures, or CPL cannot provide prompt written assurance upon OptiNose’s reasonable written request that CPL can effect timely Manufacture and/or Delivery for more than [***] ([***]) days after such request, or (iv) this Agreement is terminated by OptiNose pursuant to Section 11.3, (each of (i) — (iv), a “Supply Failure”), OptiNose shall be relieved of its obligation to obtain any Product from CPL under this Agreement and shall be entitled to instead obtain Product from the Back-up Supplier, provided, that upon subsequent timely cure by CPL of a Supply Failure described in subsections (i), (ii) or (iii) above, OptiNose shall within [***] ([***]) days of such cure resume ordering the Annual Minimum requirements of Product from CPL, with the Annual Minimum modified from and after such resumption for the remainder of the Term, as provided in the definition of Annual Minimum. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Supply Failure. In the event that: If within any [*] period (icalculated on a rolling basis) the Facility fails an inspection Qorvo is unable to supply (or suffers a hold or disciplinary action by the FDA or any other government authority that prevents CPL from Delivering Product and CPL fails to cure such inspection shortcoming, or remove or resolve such hold or disciplinary action in such a manner that the Facility passes re-inspection by the FDA or applicable government authority and/or is free have supplied) at least [*]% of the hold or disciplinary action, quantities of any Product ordered by Zomedica in good standing with FDA or such other applicable government authority, and is lawfully able to and does resume timely and conforming manufacture and delivery of OptiNose’s Product requirements in accordance with this Agreement a Conforming Purchase Order within [***] ([***]) days of such original inspection, or imposition of after the hold or disciplinary action; (ii) CPL materially breaches obligations or requirements under this Agreement related to the Manufacture and Delivery of the Product as delivery date set forth herein and fails to cure in such breach within [***] Conforming Purchase Order ([***]) days of notice thereof by OptiNose, provided, however, that such [***] ([***]) day cure period shall be extended by up to an additional [***] ([***]) days if such breach is reasonably curable within such period and if CPL is diligently working to cure such breach as soon as practicable; (iii) a Force Majeure preventing CPL from effecting timely Manufacture and/or Delivery of OptiNose’s requirements of Product endures, or CPL cannot provide prompt written assurance upon OptiNose’s reasonable written request that CPL can effect timely Manufacture and/or Delivery for more than [***] ([***]) days after such request, or (iv) this Agreement is terminated by OptiNose pursuant to Section 11.3, (each of (i) — (iv), a “Supply Failure”), OptiNose shall be relieved then the following terms will apply (not to exceed [*]): (a) upon the first occurrence of its obligation to obtain any Product from CPL under this Agreement and shall be entitled to instead obtain Product from the Back-up Supplier, provided, that upon subsequent timely cure by CPL of a Supply Failure described within a [*] period, i) the Parties will promptly discuss in subsections good faith the causes of such Supply Failure, ii) Qorvo will provide to Zomedica a recovery plan to promptly remediate such Supply Failure, and iii) the Price for such late-delivered Products that are subject to such first Supply Failure will be reduced by [*] (b) upon the second occurrence of any Supply Failure within the same [*] period, no later than two weeks following the Supply Failure, Qorvo will (i) initiate an internal corrective action request through its CIS system to attempt to ascertain the root cause of such Supply Failure (such investigation to be completed no later than eight days following initiation), (ii) or develop an action plan to address any such causes identified on a going-forward basis, (iii) abovedeliver the results of such investigation (including the action plan) to Zomedica promptly following the conclusion of such investigation, OptiNose shall and (iv) the Price for such late-delivered Products that are subject to such second Supply Failure will be reduced by [*]; and (c) upon the third occurrence of any Supply Failure within the same twelve-month period, Qorvo will take such actions described in subclause (b) of this Section 7.5.2 (Supply Failure) with respect to such third Supply Failure and the Price for such late-delivered Products that are subject to such third Supply Failure will be reduced by [*]. For clarity, for purposes of this Section 7.5.2 (Supply Failure), in no event will more than one Supply Failure be deemed as having occurred with respect to any single Conforming Purchase Order for which Qorvo fails to supply (or have supplied) at least [*] of any Product within [***] ([***]) days of after the delivery date set forth in such cure resume ordering the Annual Minimum requirements of Product from CPL, with the Annual Minimum modified from and after such resumption for the remainder of the Term, as provided in the definition of Annual Minimum. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsConforming Purchase Order.

Supply Failure. 2.10.1 In the event that: (ia) the Facility fails an inspection or suffers a hold or disciplinary action by the FDA or any other government authority that prevents CPL Hikma from Delivering its ability to Deliver Product and CPL Hikma fails to cure such inspection shortcoming, or remove or resolve such hold or disciplinary action in such a manner that the Facility passes re-inspection by the FDA or applicable government authority and/or is free of the hold or disciplinary action, in good standing with FDA or such other applicable government authority, and is lawfully able to and does resume timely and conforming manufacture and delivery Delivery of OptiNose’s Product requirements in accordance with this Agreement within [***] ([***]) days of such original inspection, or imposition of the hold or disciplinary action; (iib) CPL materially Hikma breaches its obligations or requirements under this Agreement related to the Manufacture and Delivery of the Product as set forth herein Product, other than for a Quantitative Defect, and fails to cure such breach within [***] ([***]) days from Hikma’s receipt of notice thereof by a Notice of breach from OptiNose, provided, however, that such [***] ([***]) day cure period shall be extended by up to an additional [***] ([***]) days if such breach is reasonably curable within such period and if CPL is diligently working to cure such breach as soon as practicable; (iiic) a Force Majeure preventing CPL from effecting timely Manufacture and/or Delivery of OptiNose’s requirements of Product endures, or CPL cannot provide prompt written assurance upon OptiNose’s reasonable written request that CPL can effect timely Manufacture and/or Delivery for should Hikma have more than [***] ([***]) days after such request, ; or (ivd) this Agreement is terminated by OptiNose pursuant to Section 11.3, 11.4.1; (each of a) (i) — (ivd), a “Supply Failure”), OptiNose shall be relieved have the right (at no cost or expense to OptiNose) to terminate the portion of its obligation the applicable Purchase Order(s) subject to obtain any Product from CPL under this Agreement and the Supply Failure on the understanding that OptiNose shall be entitled required to instead obtain purchase whatever conforming Product from Hikma can supply under such Purchase Order(s) and that the Backnon-up Supplierconforming portion(s) of such Purchase Order(s) shall count against the applicable Annual Minimum for the Calendar Year in question without any obligation on OptiNose to ultimately purchase a replacement amount for such non-conforming Product. Further, provided, that upon subsequent timely cure by CPL of OptiNose shall have the right to terminate any Purchase Order(s) outstanding during a Supply Failure described Failure, any Purchase Order(s) for any Binding Period that would have become binding during a Supply Failure, or any other Purchase Order that OptiNose may have intended to be issued during any instance of an outstanding Supply Failure, in subsections all instances (i), ) such termination right shall exist up to the date Hikma has cured any outstanding Supply Failure(s) and provides written notice to OptiNose that Hikma has cured such outstanding Supply Failure(s) and (ii) the amount of Product ordered or (iiithat would have been ordered under such terminated Purchase Orders(s) aboveshall count against the applicable Annual Minimum. 2.10.2 The rights set forth in Section 2.10.1 regarding OptiNose’s ability to terminate Purchase Order(s) and have such Product count against the Annual Minimum shall apply if a Force Majeure event occurs or is ongoing that prevents Hikma from timely Manufacture and Delivery of Product; provided that such adjustment of the Annual Minimum shall only apply for the duration of such Force Majeure event and it being understood that such Force Majeure shall not be considered a Supply Failure; provided, OptiNose however, that the Parties agree that the Annual Minimum shall within [***] (be [***]) days of such cure resume ordering . 2.10.3 Additionally, the Annual Minimum requirements of Product from CPLshall, with the Annual Minimum where applicable, be modified from and after such Hikma’s resumption of supplying the Product to OptiNose after a Supply Failure for the remainder of the Term, as provided in the definition of Annual Minimum. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Supply Failure. In the event that: (ia) the Facility fails an inspection or suffers a hold or disciplinary action by the FDA or any other government authority that prevents CPL from Delivering Product and CPL fails Should Supplier not be able to cure such inspection shortcoming, or remove or resolve such hold or disciplinary action in such a manner that the Facility passes re-inspection by the FDA or applicable government authority and/or is free supply at least [***] of the hold or disciplinary action, in good standing with FDA or such other applicable government authority, and is lawfully able quantities of Product ordered by Purchaser pursuant to and does resume timely and conforming manufacture and delivery of OptiNose’s Product requirements purchase orders in accordance with this Agreement Section 5.2 for any [***] period within [***] of the dates specified in such purchase orders in compliance with this Agreement for any reason, then such event shall be deemed a “Supply Failure.” Notwithstanding the foregoing, such event shall not be deemed a Supply Failure if such event is caused by a force majeure event (as described in Section 13.6), provided that (i) Supplier notifies Purchaser immediately upon the occurrence of such force majeure event, and (ii) such force majeure event lasts no longer than [***]) days of such original inspection, or imposition of the hold or disciplinary action;. (iib) CPL materially breaches obligations or requirements In the event of a Supply Failure, Purchaser’s obligation under this Agreement related Section 5.3 to purchase the Minimum Purchase Obligation of Product from Supplier shall terminate, subject to the Manufacture terms of Section 8.4(c) below. (c) In the event that a Supply Failure occurs and Delivery such Supply Failure is the first Supply Failure to occur during the Term of this Agreement, at the Product as set forth herein written request of Supplier, if Supplier has taken the necessary steps to ensure that a Supply Failure will not re-occur, the Parties shall discuss in good faith reinstating Purchaser’s obligation under Section 5.3 to purchase the Minimum Purchase Obligation from Supplier. If the Parties mutually agree in good faith that Supplier has remedied the Supply Failure and fails has taken all steps necessary to cure such breach within ensure that a Supply Failure will not re-occur, Purchaser’s obligation under Section 5.3 to purchase the Minimum Purchase Obligation from Supplier shall be reinstated, effective [***] following the date of such agreement (such effective date of reinstatement, the “Minimum Purchase Obligation Re-instatement Date”); provided, however, that, (i) for the [***]] period (as described in Section 5.3) days of notice thereof by OptiNosethat Purchaser’s obligation to purchase the Minimum Purchase Obligation is re-instated, provided, however, that the Minimum Purchase Obligation shall be pro-rated for the time remaining in such [***] ([***]) day cure period shall be extended by up to an additional [***] ([***]) days if such breach is reasonably curable within such period following the Minimum Purchase Obligation Re-instatement Date; and if CPL is diligently working to cure such breach as soon as practicable; (iii) a Force Majeure preventing CPL from effecting timely Manufacture and/or Delivery of OptiNose’s requirements of Product endures, or CPL cannot provide prompt written assurance upon OptiNose’s reasonable written request that CPL can effect timely Manufacture and/or Delivery for more than [***] ([***]) days after such request, or (iv) this Agreement is terminated by OptiNose pursuant to Section 11.3, (each of (i) — (iv), a “Supply Failure”), OptiNose shall be relieved of its obligation to obtain any Product from CPL under this Agreement and shall be entitled to instead obtain Product from the Back-up Supplier, provided, that upon subsequent timely cure by CPL of a Supply Failure described in subsections (i), (ii) or (iii) abovePurchaser’s obligation to purchase the Minimum Purchase Obligation under Section 5.3 shall be subject to, OptiNose shall within [***] ([***]) days of such cure resume ordering and modified to the Annual Minimum requirements of Product from CPLextent necessary to comply with, with any obligations incurred by Purchaser between the Annual Minimum modified from and after such resumption for the remainder date of the Term, as provided in Supply Failure and the definition of Annual Minimumdate that the Parties agreed that the Minimum Purchase Obligation should be re-instated. [***] Certain information in this document Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect This Section 8.4 shall in no way limit any of Purchaser’s legal, equitable or other remedies for Supplier’s breach of its obligations to the omitted portionssupply Product to Purchaser under Article 2.

Supply Failure. In the event that: (ia) the Facility fails an inspection or suffers a hold or disciplinary action by the FDA or any other government authority that prevents CPL from Delivering Product and CPL fails Should Mikart not be able to cure such inspection shortcoming, or remove or resolve such hold or disciplinary action in such a manner that the Facility passes re-inspection by the FDA or applicable government authority and/or is free supply at least [***] of the hold or disciplinary action, in good standing with FDA or such other applicable government authority, and is lawfully able quantities of Product ordered by Transcept pursuant to and does resume timely and conforming manufacture and delivery of OptiNose’s Product requirements Purchase Orders in accordance with this Agreement Section 3.3 for any ([***] period within [***] of the dates specified in such Purchase Orders in compliance with this Agreement for any reason (including due to a force majeure event), then such event shall be deemed a “Supply Failure.” Notwithstanding the foregoing, such event shall not be deemed a Supply Failure if such event is caused by a force majeure event (as described in Section 6.5), provided that (i) Mikart notifies Transcept immediately upon the occurrence of such force majeure event, and (ii) such force majeure event lasts no longer than [***]) days of such original inspection, or imposition of the hold or disciplinary action;. (iib) CPL materially breaches obligations or requirements In the event of a Supply Failure, Transcept’s obligation under this Agreement related Section 3.5 to purchase the Minimum Purchase Requirement of Product from Mikart shall terminate, subject to the Manufacture terms of Section 6.4(c) below. (c) In the event that a Supply Failure occurs and Delivery such Supply Failure is the first Supply Failure to occur during the Term of this Agreement, at the Product as set forth herein written request of Mikart, if Mikart has taken the necessary steps to ensure that a Supply Failure will not re-occur, the Parties shall discuss in good faith reinstating Transcept’s obligation under Section 3.5 to purchase the Minimum Purchase Requirement from Mikart. If the Parties mutually agree in good faith that Mikart has remedied the Supply Failure and fails has taken all steps necessary to cure such breach within ensure that a Supply Failure will not re-occur, Transcept’s obligation under Section 3.5 to purchase the Minimum Purchase Commitment from Mikart shall be reinstated, effective [***] following the date of such agreement ([***]) days such effective date of notice thereof by OptiNosereinstatement, the “Minimum Purchase Requirement Re-instatement Date”); provided, however, that such that, (i) for the Contract Year [***] ([***]) day cure period shall be extended by up to an additional [***] ([***]) days if such breach is reasonably curable within such period and if CPL is diligently working to cure such breach as soon as practicable; (iii) a Force Majeure preventing CPL from effecting timely Manufacture and/or Delivery of OptiNose’s requirements of Product endures, or CPL cannot provide prompt written assurance upon OptiNose’s reasonable written request that CPL can effect timely Manufacture and/or Delivery for more than [***] ([***]) days after such request, or (iv) this Agreement is terminated by OptiNose pursuant to Section 11.3, (each of (i) — (iv), a “Supply Failure”), OptiNose shall be relieved of its obligation to obtain any Product from CPL under this Agreement and shall be entitled to instead obtain Product from the Back-up Supplier, provided, that upon subsequent timely cure by CPL of a Supply Failure described in subsections (i), (ii) or (iii) above, OptiNose shall within [***] ([***]) days of such cure resume ordering the Annual Minimum requirements of Product from CPL, with the Annual Minimum modified from and after such resumption for the remainder of the Term, as provided in the definition of Annual Minimum. [***] Certain information in this document Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect that Transcept’s obligation to purchase the Minimum Purchase Requirement is re-instated, the Minimum Purchase Requirement shall be pro-rated for the time remaining in such Contract Year following the Minimum Purchase Requirement Re-instatement Date; and (ii) Transcept’s obligation to purchase the Minimum Purchase Requirement under Section 3.5 shall be subject to, and modified to the omitted portionsextent necessary to comply with, any obligations incurred by Transcept between the date of the Supply Failure and the date that the Parties agreed that the Minimum Purchase Requirement should be re-instated. (d) This Section 6.4 shall in no way limit any of Transcept’s legal, equitable or other remedies for Mikart’s breach of its obligations to supply Product to Transcept under Article 3.