Supply Failure Sample Clauses

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 of any Supply Failure that remains uncured for forty-five (45) days following Catalent’s receipt of written notice of such Supply Failure, the parties agree that Client shall have the right (upon written notice to Catalent) to Process and have the Product Processed by another supplier, and thereafter Catalent shall supply the Product to Client on a nonexclusive basis.

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. 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. Except (i) to the extent of a Force Majeure Event (as defined in Section 14.1), (ii) as a result of a breach by Teva of its obligations hereunder, (iii) as a result of a recall, market withdrawal, withholding from the market, or other similar action with respect to the relevant Product initiated by Teva or requested or required by a Regulatory Authority (other than, under this subclause (iii), as a result of Alvotech’s breach of its obligations hereunder), (iv) as a result of Teva’s change, cancellation or modification of a purchase order other than as expressly provided for under Section 3.2, or (v) as a result of a change pursuant to Section 8.3 or any gross negligence or wilful misconduct on the part of Teva, if Alvotech is unable to deliver to Teva the full quantities ordered pursuant to a valid purchase order for a Product meeting the Quality Standards by the Scheduled Delivery Date which order has been accepted (or deemed to have been accepted) pursuant to Section 3.2(c) (and including any mutually agreed variations to such order) (such event, a “Supply Failure”), Teva will, in addition to its other rights and remedies hereunder, have the right to (a) cancel, in whole or in part, the applicable Purchase Order(s) and any binding portion of the applicable rolling forecast for the Product Alvotech failed to timely deliver and (b) purchase substitute product from an alternate source. For purposes of this Agreement, any quantities of Product not delivered by the Scheduled Delivery Date will be referred to herein as the “Shortage.” For the avoidance of doubt, timely delivery of Non-Conforming Product will not be deemed delivery by the Scheduled Delivery Date and therefore will be deemed a Shortage. In the event of a Shortage, Teva will not be required to pay for the Shortage until it is Delivered and the following credit will apply to the Transfer Price of all quantities of Product set forth in the applicable purchase order. [***] days late: [***]% [***] days late: [***]% [***] days late: [***]% [***] days late: [***]% [***] days late: [***]%

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. 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. In the event that Xxxxxxx 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 Xxxxxxx to qualify a second source for the manufacture of the Products on Xxxxxxx'x behalf, subject to all other terms and conditions of this Agreement. Xxxxxxx 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. Xxxxxxx 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. Xxxxxxx shall xxxxx 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 Xxxxxxx is again able to meet the requirements referenced above.

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. For purposes of this Agreement, a “Supply Failure” shall mean a failure by Catalent to supply Product meeting the Specifications, subject to Clauses 5.2, 5.3 and 5.4, in the quantities ordered by Palatin (subject to the limitations and terms set forth in Clauses 4.3 and 4.4) for [***] , where such failure is [***] . In the event of [***] (such event, an “Uncured Supply Failure”), Palatin shall have the right [***] . In the event of such Uncured Supply Failure, [***] , the parties shall meet to discuss in good faith how to equitably manage any Minimum Requirement for the then current Contract Year, [***] ..