Supply Failures. After the end of each calendar quarter during the Initial Exclusivity Period, Stryker will send Osiris a report of (i) all cases during such calendar quarter where Osiris fails to ship Allograft to a Customer that conforms to the requirements of this Agreement by the delivery date requested by Stryker (excluding any such cases where Stryker was able to fulfill a Customer request from Allograft inventory held in consignment at such Customer) (each, a “Supply Failure”) and (ii) for each Supply Failure, the amount that the Customer would have paid for the Allograft Services for said order (the “Lost Revenue”). Osiris’s inability to fulfill a Customer request will not constitute a “Supply Failure” (x) to the extent due to (a) Customer or Stryker error (e.g., incorrect shipping information), (b) Force Majeure Events or (c) transportation or shipping errors due to the failure by one or more common carriers or (y) to the extent orders for the pertinent calendar quarter exceed the average of Stryker’s rolling forecasts for the pertinent calendar quarter by 25% or more. For the purposes of Section 6.2(b)(ii) and Section 6.5, a “Supply Failure Trigger” shall be deemed to have occurred if both of the following conditions are met with respect to the Initial Exclusivity Period:
(i) the actual cumulative Revenue for the Initial Exclusivity Period (the “Actual Revenue”) is less than [***]; and
(ii) the sum of the Actual Revenue and the aggregate Lost Revenue for the Initial Exclusivity Period is greater than [***].
Supply Failures. 6.1 OSI Failure to Comply with Manufacturing Obligations "Triggering Events". In the event of the occurrence of any of the following events (each a "Triggering Event"), the provisions of Section 6.2 shall apply:
6.1.2 Other FDA Actions that would Result in Inability to Supply. For the purposes of Section 6.2, it shall be a Triggering Event if the FDA takes actions against OSI or any of its Acceptable Contract Manufacturers that will cause OSI to be unable to supply Finished Product and/or Placebo such that it is reasonably likely that the supply failures set forth in Section 6.1.3 or Section 6.1.4 will occur.
Supply Failures. Without limiting Client’s other rights or remedies in this Agreement, if Catalent is unable to deliver the quantities of Product ordered in a Purchase Order within […***…] days of the scheduled delivery date, and/or delivers Product that does not conform to the Specifications […***…] (each a “Supply Failure”), on […***…] or more separate occasions within a […***…]-month period, the percentage of Client’s commercial requirements that it is obligated to purchase from Catalent for the Territory pursuant to Section 4.1 above shall be reduced from […***…] percent ([…***…]%) to […***…] percent ([…***…]%) and the Minimum Commitment shall be reduced from $[…***…] to $[…***…] (pro-rated for any partial Contract Year). In such case, such reduced percentage and Minimum Commitment shall apply until Catalent has no Supply Failures for a […***…]-month period in which case the percentage and Minimum Commitment, respectively, shall revert to the amounts set forth in Section 4.1. Notwithstanding the foregoing, if Catalent has […***…] or more Supply Failures within a […***…]-month period, the parties will meet and agree on and implement a delivery improvement action plan within […***…] business days. If, after the delivery improvement plan is in place, […***…] additional Supply Failures occur within a […***…]-month period, these Supply Failures may be considered a material breach of this Agreement by Client under Section 16.2(B) and Catalent will not be allowed any further opportunity to remedy the material breach. Notwithstanding the foregoing, a Supply Failure for purposes of this Section 5.6 will not include any delay in shipment of Product caused by events outside of Catalent’s reasonable control, such as a force majeure event, FINAL a delay in delivery of API or other Client-supplied Materials, or receipt of non-conforming API or Client-supplied Materials.
Supply Failures. The Commercial Supply Agreement will include provisions detailing the rights and obligations in the event that Agilent fails to supply specified percentages of Product ordered by Customer under the Commercial Supply Agreement during a defined period of time, which rights will include a release from Customer’s obligation to purchase [**]% of its requirements of Product for use in the Territory.
Supply Failures. If, during any Measurement Period occurring during the Term, in at least […***…] months of such Measurement Period or in any […***…] months occurring during any such Measurement Period, there is an occurrence of insufficient volume (as determined by standards to be developed by the Parties within […***…] days after the Effective Date) of Product in the retail distribution channel or in any significant portion of the retail distribution channel to meet orders for Product, as determined from a review of all relevant information, including information contained in Horizon’s warehouse inventory reports and in relevant EDI-852 forms (any such occurrence with respect to the Product during any particular Measurement Period, a “Supply Failure”), then Mallinckrodt shall have the right, within […***…] days after the end of any such Measurement Period in which a Supply Failure occurs, to terminate this Agreement in its entirety effective upon […***…] days written notice to Horizon, subject to the consequences of such termination as set forth in Section 8.3 below.
Supply Failures. After Regulatory Approval of an IVD Assay, if Illumina fails to reasonably meet commercial demand for the IVD Assay in a Market, unless such failure is caused in whole or in part by Partner or one or more persons acting on Partner’s behalf, then Partner may provide written notice to Illumina, and if Illumina fails to cure such situation within sixty (60) days after receipt of such notice then, upon Partner’s request, the Parties will negotiate a potential a Replacement Diagnostic Solution for such Market pursuant to Section 5.10.
Supply Failures. (a) If Seres fails to deliver a quantity of sellable units of Product conforming to the Specifications and other requirements of this Agreement and the Quality Agreement that is equivalent to at least [***] of the total quantity of Product ([***] as contemplated under section 2.6 above, [***]) required to be delivered by Seres pursuant to a valid Purchase Order placed by NESA within [***] after the applicable Delivery Date and such failure is not excused under the terms of this Agreement (“Supply Failure”), Seres shall pay [***] (“Supply Penalty”); provided, however that the aggregate Supply Penalty shall not exceed [***] of the total Supply Cost for such Purchase Order. For purposes of clarity, the Supply Penalty will be measured and applied on a Purchase Order by Purchase Order basis. The Supply Penalty shall be applied only for the late Purchase Order. For the avoidance of doubt, the Supply Penalty shall be borne exclusively by Seres and shall not constitute an Allowable Expense.
(b) If there is a Material Supply Failure that is not cured by Seres after [***] written notice of such Material Supply Failure from NESA, NESA may [***]. The decision [***] shall be made by the [***] and keep the Manufacturing Working Group informed of the status of | such implementation efforts [***] in meetings of the Manufacturing Working Group where such implementation efforts are to be discussed. [***].
Supply Failures. 3.7.1. It is of essence to this Agreement that ULURU delivers the Products at the date stated in the purchase order. In the event that ULURU fails to deliver the Products on or before the delivery date specified in the applicable purchase order, ULURU or its Affiliates shall notify MEDA of such delay and the Parties shall consult in good faith to determine the period of such inability to supply such Product.
3.7.2. If (i) MEDA reasonably determines that such or any other inability to so supply a Product will continue for more than 90 (ninety) days, or (ii) if ULURU fails to supply any of MEDA´s purchase orders for Product and fails to cure such failure within 60 (sixty) days after the requested delivery date therefore (each of (i) and (ii) shall be referred to as a “Supply Failure”), then MEDA may, at its option either (x) agree to have ULURU supply the undelivered Product at a future date agreed upon the Parties or (ii) have up to 100 (hundred) % supplied by a secondary supplier of such Product as provided for in Article 3.8
Supply Failures. Notwithstanding anything in this Agreement to the contrary, but subject to Section 8.11(c), in the event that SomaLogic, or the Secondary Manufacturer or Tertiary Manufacturer as applicable, is unable or unwilling to (i) manufacture SOMAmer Reagents as reasonably required by Illumina (and Illumina’s Affiliates and Sublicensees) solely for use in the research, development or Commercialization of the Licensed Products, or (ii) manufacture and supply such SOMAmer Reagents at reasonably acceptable quality standards (which, at a minimum, shall be as set forth in the quality assurance agreement) (each of (i) and (ii), a “Supply Failure”), the total Minimum Royalties payable by Illumina to SomaLogic shall be reduced by the amount of any reasonably documented direct damages or losses by Illumina due to such Supply Failure; provided that SomaLogic may request reasonable evidence of such damages or losses prior to any such reduction in Minimum Royalties taking effect.
Supply Failures. In the event that MediWound becomes aware of the existence of a situation that may lead to a Supply Failure, then MediWound shall promptly (and in no event later than [***] from the date of such awareness) notify Vericel of the particular circumstances. MediWound and Vericel shall promptly discuss how to resolve such circumstances in an effort to avoid or mitigate such potential Supply Failure. MediWound shall investigate the root cause of the anticipated Supply Failure and prepare and provide to Vericel a Remediation Plan within [***] of MediWound’s notice to Vericel. If the Remediation Plan is acceptable to Vericel, and MediWound is able to reasonably assure Vericel of MediWound’s ability to Manufacture Product and, thereby, (a) avoid a Supply Failure or (b) supply Product in accordance with the Rolling Forecast within [***], then MediWound shall continue to Manufacture Product for Vericel. In all other cases, Vericel shall be permitted to take such measures as are reasonably determined in good faith by Vericel to ensure the supply of Product to the marketplace including cancelling or revising outstanding Purchase Orders and, at Vericel’s option, Vericel’s obligations under Section 2.8(a), (b) and (c) shall be deemed terminated.
