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. If within any [*] period (calculated on a rolling basis) Qorvo is unable to supply (or have supplied) at least [*]% of the quantities of any Product ordered by Zomedica in a Conforming Purchase Order within [*] after the delivery date set forth in such Conforming Purchase Order (“Supply Failure”), then the following terms will apply (not to exceed [*]): (a) upon the first occurrence of any Supply Failure within a [*] period, i) the Parties will promptly discuss in 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) develop an action plan to address any such causes identified on a going-forward basis, (iii) deliver the results of such investigation (including the action plan) to Zomedica promptly following the conclusion of such investigation, 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 [*] after the delivery date set forth in such Conforming Purchase Order. [*Confidential Treatment has been requested as to certain portions of this document. Each such portion, which has been omitted herein and replaced with an asterisk [*], has been filed separately with the Securities and Exchange Commission.]
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. (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. (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. (i) [***]
(ii) [***]
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(iv) [***]
(v) [***]
(vi) [***]
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