Common use of Failure to Supply Clause in Contracts

Failure to Supply. In the event, with respect to any particular Product, (i) Patheon cannot or does not, in any calendar month, supply on a timely basis supply at least [*]% of Client’s requirements for such Product, (ii) any facility involved in the manufacture or storage of such Product hereunder is prohibited from, or materially adversely affected in its ability to, produce, store, or otherwise be in involved in the provision of such Product to Client under this Agreement by the appropriate regulatory authorities or due to such failure to comply, (iii) Patheon’s receipt, within any six-month period, of more than one Form 483, warning letters or similar document from a regulatory authority relating to the manufacturing facility or Patheon’s quality systems which may indicate chronic or systematic quality problems at Patheon that could adversely impact Patheon’s ability to supply the Products or (iv) Client properly rejects Products in accordance with Section 6.1(a) and such rejection materially adversely affects Client’s ability to sell the relevant Product, then in addition to, and without limitation of, any legal or equitable remedies available to Client as a result of any breach of this Agreement by Patheon, all rights with respect to such Product shall become nonexclusive, and Client shall be free to engage a third party manufacturer or supplier of such Product (or replacement products) or manufacture it directly upon prior written notice to, but without such prior written consent of, Patheon and Patheon shall be deemed to have licensed to Client the manufacturing rights reasonably necessary to provide for such manufacture. Notwithstanding any provision of this Agreement to the contrary, all reasonable direct costs and expenses incurred by Client in connection with having such Product (or replacement products) manufactured and acquired, less the amount that Client would have paid to Patheon hereunder for such Product had Patheon complied with the terms of this Agreement, shall be borne by Patheon and paid to Client within ten (10) days of demand therefor by Client.

Failure to Supply. In If at any time during the eventTerm, with respect (a) Company is unable to any particular Productdeliver Product pursuant to a Firm Order for a period longer than [***] after the applicable delivery date set forth in the respective Firm Order for causes within Company’s control, or (b) if the Company is unable to supply, or arrange to make available for shipment the Launch Quantity within [***] of the Regulatory Approval for causes within Company’s control; then, in either case (each such occurrence a “Failure to Supply”), USWM may, upon [***] prior written notice to Company that a Failure to Supply has occurred, request in such notice that Company exercise, and Company shall, at Company’s sole cost and expense, [***] to (i) Patheon cannot or does notevaluate, in any calendar monthcontract, and qualify a mutually agreeable alternate manufacturing facility to manufacture and supply on a timely basis supply at least [*]% all of ClientUSWM’s requirements for such Productof Product(s) in the Territory, (ii) any facility involved in the manufacture or storage of such Product hereunder is prohibited from, or materially adversely affected in its ability to, produce, store, or otherwise be in involved in the provision of such Product to Client under this Agreement by the appropriate regulatory authorities or due to such failure to comply, (iii) Patheon’s receipt, within any sixtransfer sufficient know-month period, of more than one Form 483, warning letters or similar document from a regulatory authority relating how to the alternate manufacturing facility or Patheon’s quality systems which may indicate chronic or systematic quality problems at Patheon that could adversely impact Patheon’s ability in order to supply enable the Products or (ivfacility to manufacture the Product(s) Client properly rejects Products in accordance with Section 6.1(a) and such rejection materially adversely affects Client’s ability to sell the relevant Product, then in addition to, and without limitation of, any legal or equitable remedies available to Client as a result of any breach of this Agreement by Patheon, all rights with respect to such Product shall become nonexclusive, and Client shall be free to engage a third party manufacturer or supplier of such Product (or replacement products) or manufacture it directly upon prior written notice to, but without such prior written consent of, Patheon and Patheon shall be deemed to have licensed to Client the manufacturing rights reasonably necessary to provide for such manufacture. Notwithstanding any provision of this Agreement to the contrary, all reasonable direct costs and expenses incurred by Client in connection with having such Product (or replacement products) manufactured and acquired, less the amount that Client would have paid to Patheon hereunder for such Product had Patheon complied with the terms of this Agreement, and (iii) ensure that the alternate manufacturing facility is contractually obligated to use commercially reasonable efforts to be approved by the applicable Regulatory Authority to manufacture commercial quantities of the Product(s) and is brought up to production readiness as soon as reasonably possible following USWM’s written notice specified above. In the event an alternate manufacturing facility is utilized to supply Products under this Agreement, such facility shall be borne deemed a “Manufacturing Facility” for purposes of this Agreement. Subject to Company [***], the Parties may mutually agree to terminate this Agreement (either with respect to the ZIMHI Product or the SYMJEPI Product individually, or both Products collectively). Notwithstanding anything in this Section 11.2.2(a), in the event that a Failure to Supply arises by Patheon the willful act or omission of Company (and paid not for other reasons including without limitation acts or omissions of third parties beyond the reasonable control of Company or acts or omissions relating to Client [***] taken in good faith by Company), USWM may, in its sole discretion, elect to terminate this Agreement (either with respect to the ZIMHI Product or the SYMJEPI Product individually, or both Products collectively, as the case may be) at the end of such [***] notice period, and Company shall pay to USWM within ten [***] of the [***] an amount equal to [***]. In the event that either (10i) days Company fails to [***], or (ii) supply of demand therefor by Clientthe affected Product(s) fails to resume within [***] from [***], USWM may, in its sole discretion, elect to terminate this Agreement (either with respect to the ZIMHI Product or the SYMJEPI Product individually, or both Products collectively) unless supply of the affected Product(s) resumes during such [***] notice period and, in the event that USWM elects to terminate this Agreement (either with respect to the ZIMHI Product or the SYMJEPI Product individually, or both Products collectively, as the case may be) Company shall pay to USWM within [***] of the effective date of termination an amount equal to [***] of (a) [***], or (b) [***]. For purposes of clarity, the remedies available to USWM pursuant to this Section 11.2.2(a) are in addition to any other remedies available to USWM under this Agreement, including without limitation, USWM’s indemnification rights pursuant to Section 8.1. Notwithstanding the foregoing, USWM shall not be entitled to exercise the remedies in this Section 11.2.2(a) upon a Failure to Supply as a result of a Force Majeure event in accordance with Section 12.10.

Failure to Supply. In If ICU fails to deliver, or anticipates that it will be unable to deliver, Products ordered pursuant to the eventterms of this Agreement for 60 or more consecutive days past any Delivery Date, ICU will promptly notify Hospira. Hospira shall have the right to (i) agree to a revised delivery date, (ii) cancel some or all existing Purchase Orders for such Products without penalty, (iii) transfer the manufacture of such Products to itself or a Third Party, or (iv) to the extent such failure to supply is a material breach, terminate this Agreement in accordance with Section 13.3. ICU shall not be deemed to have failed to deliver under the preceding sentence if it is unable to manufacture Products ordered by Hospira as a direct result of Hospira's failure to supply ICU with Specified Components under Section 5.2 hereof or as a direct result of Hospira's breach of its obligations under Sections 3.1(a), (b) or (c). If Hospira elects option (iii), ICU shall, if so requested by Hospira, (A) transfer and/or license to Hospira, as applicable, all know-how, technology, trade secrets and patent rights necessary to manufacture such Products (other than with respect to any particular Product, (i) Patheon cannot or does not, in any calendar month, supply on a timely basis supply at least [*]% of Client’s requirements for such Product, (ii) any facility involved in the manufacture or storage component of such Product hereunder is prohibited fromthat can be timely supplied by ICU), thereby enabling Hospira or materially adversely affected in its ability todesignee to manufacture such Products, produce, store, (B) reasonably assist Hospira or otherwise be in involved its designee in the provision transfer and the start-up of manufacturing operations for such Product Products and make all necessary plans, formulations and manufacturing processes, procedures, test methods, specialized test equipment, and other items available to Client under this Agreement by the appropriate Hospira or its Confidential designee, (C) grant Hospira or its designee access to ICU's regulatory authorities or due files relating to such failure to complyProducts, (iiiD) Patheon’s receipttransfer all Regulatory Approvals to Hospira necessary to manufacture, within any six-month period, of more than one Form 483, warning letters or similar document from a regulatory authority relating to the manufacturing facility or Patheon’s quality systems which may indicate chronic or systematic quality problems at Patheon that could adversely impact Patheon’s ability to supply the Products or (iv) Client properly rejects Products in accordance with Section 6.1(a) market and sell such rejection materially adversely affects Client’s ability to sell the relevant Product, then in addition toProducts, and (E) supply such other technical or regulatory assistance as is reasonably requested by Hospira or its designee. ICU hereby grants to Hospira, without limitation of, any legal or equitable remedies available to Client as a result the necessity of any breach of this Agreement further documentation, a non-exclusive, royalty free, irrevocable, worldwide right and license to ICU's know-how, technology, trade secrets and patent rights to make, have made, use and sell such Products. To the extent any know-how, technology, trade secrets or patent rights are owned, controlled or licensed by Patheon, all rights with respect to such Product shall become nonexclusivea Third Party ("Third Party Rights"), and Client are required to implement Hospira's right to manufacture or have manufactured such Products, ICU shall be free use its best efforts to engage obtain a third party manufacturer license to all such Third Party Rights to allow Hospira or supplier its designee to use such Third Party Rights for the production of such Product (or replacement products) or manufacture it directly upon prior written notice to, but without such prior written consent of, Patheon and Patheon shall be deemed to have licensed to Client the manufacturing rights reasonably necessary to provide for such manufacture. Notwithstanding any provision of this Agreement to the contrary, all reasonable direct costs and expenses incurred by Client in connection with having such Product (or replacement products) manufactured and acquired, less the amount that Client would have paid to Patheon hereunder for such Product had Patheon complied with the terms of this Agreement, shall be borne by Patheon and paid to Client within ten (10) days of demand therefor by ClientProducts.

Failure to Supply. In the event, with respect to event that any particular Product, of the following occur: (ia) Patheon cannot or does not, in any calendar month, supply on a timely basis supply at least [*]% of Client’s requirements for such Product, (ii) any facility involved in the manufacture or storage of such Product hereunder is prohibited from, or materially adversely affected in its ability to, produce, store, or otherwise be in involved in the provision of such Product to Client under this Agreement by the appropriate regulatory authorities or due to such failure to comply, (iii) Patheon’s receipt, within any six-month period, of more than one Form 483, warning letters or similar document from a regulatory authority relating to the manufacturing facility or Patheon’s quality systems which may indicate chronic or systematic quality problems at Patheon that could adversely impact Patheon’s ability to supply the Products or (iv) Client properly rejects Products Manufacturer notifies Buyer in accordance with Section 6.1(a) 4.03 that Manufacturer will not be able to fulfill Buyer’s Purchase Order as requested by Buyer and such rejection materially adversely affects Clientwhich Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s ability to sell requested dates for delivery of Purchase Orders must comply with the relevant Product, then requirements in addition to, and without limitation of, any legal or equitable remedies available to Client Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) ; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order (whether due to the occurrence of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”), then (i) immediately following such Failure to Supply Buyer may, in addition to any breach of this Agreement by Patheonother rights and remedies hereunder, all rights with respect to purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall become nonexclusiveprovide Buyer and such other manufacturer with assistance, and Client shall be free to engage a third party manufacturer or supplier of such Product (or replacement products) or manufacture it directly upon prior written notice toas reasonably requested, but without such prior written consent of, Patheon and Patheon shall be deemed to have licensed to Client the manufacturing rights reasonably necessary to provide for such manufacture. Notwithstanding any provision of this Agreement to the contrary, all reasonable direct costs and expenses incurred by Client in connection with having such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or replacement productsdistribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) manufactured Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and acquired(v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, less information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the amount contrary contained in this Agreement, in the event that Client would Buyer shall make or have paid made Product, pursuant to Patheon hereunder for this Section 12.02, Buyer shall be permitted to disclose to any third party any Confidential Information as is reasonably necessary in connection with such Product had Patheon complied with activities (subject to such third party agreeing in writing to be bound by the terms of this AgreementArticle 15 hereof), shall be borne by Patheon save and paid to Client within ten except for the direct labour (10) days variable costs), fixed overhead costs and profit margins of demand therefor by Clientthe Manufacturer.

Failure to Supply. The parties will agree about the quantity to be delivered in forecasts that will be determined by the parties each year. In the event, with respect to any particular Product, event that Ovamed fails (i) Patheon cannot or does not, in any calendar month, supply on a timely basis to satisfactorily supply at least [*******]% of Client’s requirements for such Productthe amount of Product in any particular order within [*******] of the required delivery date or at least [*******]% of the amount of Product in any particular order within [*******] of the required delivery date, (ii) any facility involved to substantially perform its obligations in connection with United States or other relevant Regulatory Approval of the manufacture or storage of Products and such Product hereunder is prohibited fromfailure has continued for more than [*******], or materially adversely affected in its ability to, produce, storesuch longer period as reasonably necessary to cure such failure or such period required by the relevant Regulatory Approval authority, or otherwise be in involved in the provision of such Product to Client under this Agreement by the appropriate regulatory authorities or due to such failure to comply, (iii) Patheon’s receiptto have adequate operational manufacturing facilities such that it is unable to manufacture Product, within any six-month period, of more than one Form 483, warning letters or similar document from a regulatory authority relating unable to the manufacturing facility or Patheon’s quality systems which may indicate chronic or systematic quality problems at Patheon that could adversely impact Patheon’s ability to supply the Products or (iv) Client properly rejects Products manufacture product in accordance with Section 6.1(aSpecifications, for a period of [*******] or more ((i), (ii) and (iii) individually or collectively referred to herein as the “Manufacturing Failure”), and (x) Ovamed does not, at the time, have the right to terminate this Agreement under Section 8.2.1 and (y) Collingwood has not, at the time, developed a commercial second source (on commercially reasonable terms) for a product that can be substituted for the Product and that can meet the supply shortage resulting from Ovamed’s failure to supply, then, upon notice of such rejection materially adversely affects Client’s ability failure from Collingwood, Collingwood may terminate this Agreement and receive a worldwide, royalty-free, perpetual, non-transferable (except as set forth in Section 13.3 below), non-exclusive, fully paid license, with the right to grant sublicenses for the sole purpose of manufacturing the Product on behalf of Collingwood (provided each such sublicensee signs a confidentiality agreement with Ovamed on terms consistent with the confidentiality obligations under this Agreement), under all intellectual property owned by Ovamed or for which Ovamed has the right to grant a license or sublicense pursuant to this Section and which is reasonably necessary or useful to manufacture and sell the relevant ProductProduct in the Field of Use (the “Manufacturing IP”) (collectively, then in addition tothe “Manufacturing Failure License”), and without limitation of, any legal or equitable remedies available to Client as a result such license shall be effective immediately upon notice of any breach of this Agreement such election by Patheon, all rights with respect to such Product shall become nonexclusiveCollingwood, and Client (b) Ovamed shall be free provide all assistance reasonably requested by Collingwood to engage assist Collingwood or a third party manufacturer or supplier acting on behalf of Collingwood in the manufacturing of the Product in accordance with the Specifications, provided however, that Collingwood shall reimburse Ovamed for any reasonable expenses it incurs in relation to its rendering of such assistance; Notwithstanding anything to the contrary herein, if Ovamed delivers to Collingwood a remediation plan reasonably acceptable according to which full remediation of any Manufacturing Failure will be achieved within [*******] from the first date of such Manufacturing Failure, then this Agreement shall remain in effect, provided however, that Collingwood shall have the right to use and have used all Manufacturing IP to manufacture or have manufactured Product (or replacement products) or manufacture it directly upon prior written notice to, but without during such prior written consent of, Patheon and Patheon period that Ovamed is engaged in such remediation. Such plan shall be deemed delivered to have licensed to Client Collingwood within 30 days after the manufacturing rights reasonably necessary to provide for such manufacturefailure occurred. Notwithstanding any provision of Collingwood may terminate this Agreement immediately, without penalty or further obligation to Ovamed, if Ovamed fails to achieve remediation within such [*******] period and Collingwood shall immediately be entitled to the contrary, all reasonable direct costs and expenses incurred by Client in connection with having such Product (or replacement products) manufactured and acquired, less the amount that Client would have paid to Patheon hereunder for such Product had Patheon complied with the terms of this Agreement, shall be borne by Patheon and paid to Client within ten (10) days of demand therefor by ClientManufacturing Failure License.