Supply Failure Clause Samples

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. (a) During the term of this Agreement in which Patheon, for any reason, except to the extent due to Client’s failure to supply Active Materials, including, without limitation, force majeure as defined in Section 13.7, fails to supply at least [***] of the quantities of Product in any two (2) consecutive calendar quarters in a Year pursuant to Firm Orders submitted by Client pursuant to and in accordance with the terms and conditions of this Agreement within thirty (30) days of the dates specified in such Firm Orders in compliance with this Agreement, then such event shall be deemed a “Supply Failure.” (b) In the event of a Supply Failure, Client’s obligation under Section 3.1 to purchase the Purchase Commitment of Product from Patheon shall terminate and Client shall be free to purchase any amount of Product from any third party for any purpose without restriction, subject to the terms of Section 3.6(c) below. Notwithstanding anything to the contrary in Section 3.1 above (including the Purchase Commitment): (i) Client shall have the right, at any time, to qualify a third party manufacturer such that such third Party may manufacture and commercially supply Product to Client in the event of a Supply Failure; and (ii) as part of such qualification process, such third party may manufacture and supply for Client, at any time (including during the term of this Agreement), quantities of Product reasonably necessary for such qualification; provided, however, that, except as provided otherwise in this Section 3.6 in the event of a Supply Failure, for so long as the Purchase Commitment is in effect, Client shall only be allowed to sell (x) [***] of Product produced by such third party manufacturer, and (in addition to the amounts described in the foregoing part (x)) (y) annually, [***] of Product produced by such third party manufacturer. Patheon shall, at Client’s cost, cooperate with Client and assist in the transfer to Client of all legal and technical documents concerning Active Materials and Products, including master batch records, validation reports, stability reports and relevant manufacturer authorizations, existing retention samples and all such other documents and materials as may be reasonably necessary or useful for Client to source Products from other qualified third parties. Client shall reimburse Patheon for all of Patheon’s reasonable time, material and other costs associated with the qualification of a third party manufacturer. (c) In the event tha...

Supply Failure. In the event that NOF is unable to supply at least [**] percent ([**]%) of SAVIENT’S Firm Forecast quantities (hereinafter, a “Supply Failure”), then both parties agree to meet and use their best efforts to solve such Supply Failure.

Supply Failure. Without limiting any other rights or remedies of Shire, if any, particularly in case of a force majeure event, if there is, or the Parties mutually determine there is likely to be, a Supply Failure, then Shire shall have the right to purchase DBS test kits from any Third Party manufacturer and Centogene shall process such DBS cards without additional processing fee (as defined in Section 3.2 of the Global Master Services Agreement), as will be set forth in an amendment to the Global Master Services Agreement.

Supply Failure. If for any reason, including for an Event of Loss, Amneal fails to supply [***] (each [***], a “Supply Failure”), Metsera may meet the shortfall from any alternate source(s) and shall, to the extent that the amount of the actual supply price paid by Metsera in meeting such shortfall by procuring from alternate source(s) is greater than the Supply Price for the equivalent amount and type of Product, be entitled to credit such greater amount against future orders for Product from Amneal up to an amount equal to [***]. In addition, Metsera shall receive the Construction Rebate against the Supply Price for the amount of such shortfall purchased by Metsera from the alternate source(s) in accordance with Section 7.5, even if Metsera purchases the shortfall from alternate sources for longer than [***]. Moreover, in Metsera’s sole discretion, Metsera may elect to reduce Metsera’s annual Minimum Order Quantity purchase obligation and/or the Supply Threshold by the total shortfall amounts of any Product that is the subject of a Supply Failure. Notwithstanding the foregoing, in the event that any shortfall or failure to supply as described in subclauses (a) or (b) above was attributable to [***], such shortfall or failure to supply shall not be deemed a Supply Failure, provided that with respect to subclause (ii), Amneal is in compliance with its obligations to maintain safety stock in accordance with Section 18. WITHOUT LIMITING THE PARTIES’ RIGHTS AND OBLIGATIONS UNDER SECTIONS 3.3, 6.2, 12.3, 24 OR 27 (solely with resect to Metsera’s right to terminate), THIS SECTION 13.2 STATES METSERA’S AND ITS AFFILIATE’S SOLE AND EXCLUSIVE RIGHT AND REMEDY FOR ANY SUPPLY FAILURE. Notwithstanding the foregoing, nothing in this 12.3 is intended to or shall limit or restrict any rights or remedies of Metsera or its Affiliates resulting from Amneal’s or its Affiliate’s gross negligence, willful misconduct or fraud. The limitations of liability in Section 24.4(B) shall not apply to this Section 13.2.

Supply Failure. (i) AstraZeneca delivers less than [***] percent ([***]%) of the aggregate total volume of all commercial presentations of the Product ordered by Prometheus pursuant to Purchase Orders under the terms of this Agreement for delivery in any month; or (ii) AstraZeneca delivers less than [***] percent ([***]%) of the aggregate total volume of all Sample Product presentations ordered by Prometheus pursuant to Purchase Orders under the terms of this Agreement for delivery in any month (each of the events described in clauses (i) and (ii) is referred to as a "Supply Failure"); and (b) the Supply Failure is not cured by AstraZeneca within [***] after the end of the month in which the Supply Failure occurred; provided, however that AstraZeneca shall not have the *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. right to cure a Supply Failure pursuant to this Section 7.1.3(b) if Supply Failures described in Section 7.1.3(a) have occurred more than [***] times in any prior twelve (12) month period.

Supply Failure. If Supplying Party materially fails to supply, or have supplied, quantities of Product that it is required to supply, except as a result of a default by Ordering Party or force majeure event, Supplying Party will, at Ordering Party’s written request, provide Ordering Party (including any Third Party contract manufacturer designated by ARL) with access to and the right to use, without charge (other than the administrative costs of transfer), all Supplying Party manufacturing intellectual property (including without limitation, Patents, Know-How, and related information and materials) necessary or reasonably useful to manufacture such Product, except that Ordering Party shall not exercise such rights (a) through a competitor of Supplying Party or (b) in any country that does not adhere to and respect internationally recognized intellectual property and trade regulations. The Supply Agreement will include mechanisms for the transfer of such intellectual property to Ordering Party in the event of such failure to supply. If Ordering Party elects to exercise such rights to manufacture or have manufactured Product, then, at such time as Supplying Party or its contract manufacturer can reasonably demonstrate its ability to again supply Product in accordance with the Supply Agreement, such manufacturing rights of Ordering Party shall cease and Supplying Party shall have the right to supply Product.

Supply Failure. (a) Subject to the provisions of the Commercial Supply Agreement, if during the term of the Commercial Supply Agreement, Clearside fails to supply REGENXBIO with at least [***] of the quantities of Clearside Devices that Clearside is obligated to supply (provided such quantities do not exceed REGENXBIO’s most recent forecast) on at least [***] occasions in any consecutive [***] period for any reason other than due to the material breach by REGENXBIO of the Commercial Supply Agreement (a “Supply Failure”), REGENXBIO may, Certain information has been excluded from this agreement (indicated by “[***]”) because such information (i) is not material and (ii) would be competitively harmful if publicly disclosed. 20 at its sole discretion, upon not less than [***] written notice to Clearside (a “Supply Failure Notice”): (i) require Clearside to supply the undelivered Clearside Devices at a future date to be agreed upon by the Parties; and/or (ii) elect to have one or more Third Parties identified by REGENXBIO Manufacture Clearside Devices (an “Alternative Manufacturer Election”), in which case REGENXBIO will require its Third Party Manufacturer to only Manufacture and sell such Clearside Devices for REGENXBIO’s and its Affiliates’ and Sublicensees’ Exploitation in connection with Covered Product within the scope of the Commercial License. (b) Upon the occurrence of a Supply Failure and an Alternative Manufacturer Election: (i) REGENXBIO (or its designated Third Party manufacturer) will have the right to Manufacture Clearside Devices within the scope of the license under Section 3.1, and (ii) Clearside shall transfer the Clearside Manufacturing technology to REGENXBIO and any Third Party Manufacturers identified by REGENXBIO as specified in the following sentence. Clearside shall promptly (x) disclose to REGENXBIO and any such Third Party Manufacturer all Clearside Manufacturing Know-How; (y) provide REGENXBIO or any such Third Party Manufacturer with the training, documentation and other information Controlled by Clearside and relating to the use of the Manufacturing process as may be necessary for REGENXBIO and such Third Party Manufacturers to Manufacture Clearside Devices; and (z) make appropriately trained personnel available for consultation and advice upon REGENXBIO’s reasonable request and expense to the extent reasonably necessary to provide technical assistance necessary to enable REGENXBIO or such Third Party Manufacturers to Manufacture Clearside Device...

Supply Failure. In the event that ▇▇▇▇▇▇▇ is unable for any reason to supply at least eighty percent (80%) of VisiJet's Firm Orders for Product in any two consecutive Quarters, VisiJet shall be entitled to require ▇▇▇▇▇▇▇ to qualify a second source for the manufacture of the Products on ▇▇▇▇▇▇▇'▇ behalf, subject to all other terms and conditions of this Agreement. ▇▇▇▇▇▇▇ shall provide all manufacturing documentation and such other assistance as may be necessary or useful to establish manufacturing operations by such third party, subject to the execution of appropriate non-disclosure restrictions. ▇▇▇▇▇▇▇ shall purchase the applicable Product(s) from such second source and sell and deliver the Product(s) to VisiJet in accordance with the provisions of, and at the prices set forth in, this Agreement. ▇▇▇▇▇▇▇ shall ▇▇▇▇▇ the second source a royalty-free, non-exclusive license to any intellectual property rights necessary to enable the second source to manufacture the Products until such time as ▇▇▇▇▇▇▇ is again able to meet the requirements referenced above.