Common use of Failure to Supply Clause in Contracts

Failure to Supply. In the event that any of the following occur: (a) Manufacturer notifies Buyer in accordance with Section 4.03 that Manufacturer will not be able to fulfill Buyer’s Purchase Order as requested by Buyer and which Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in 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 other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with 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 distribution 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) 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 (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, 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 contrary contained in this Agreement, in the event that Buyer shall make or have made Product, pursuant to 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 activities (subject to such third party agreeing in writing to be bound by the terms of Article 15 hereof), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the Manufacturer.

Failure to Supply. In If at any time during the event that any of the following occur: Term, (a) Manufacturer notifies Buyer in accordance with Section 4.03 that Manufacturer will not be able Company is unable to fulfill Buyer’s Purchase deliver Product pursuant to a Firm Order as requested by Buyer and which Purchase Order was requested in accordance with for a period longer than [***] after the terms herein (e.g., Buyer’s requested dates for applicable delivery of Purchase Orders must comply with the requirements in 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 date set forth in the applicable Purchase respective Firm Order for causes within Company’s control, or (whether due b) if the Company is unable to supply, or arrange to make available for shipment the occurrence Launch Quantity within [***] of a Force Majeure Event or otherwise) the Regulatory Approval for causes within Company’s control; then, in either case (each of (a) through (d) are referred to as such occurrence a “Failure to Supply”), then 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) immediately evaluate, contract, and qualify a mutually agreeable alternate manufacturing facility to manufacture and supply all of USWM’s requirements of Product(s) in the Territory, (ii) transfer sufficient know-how to the alternate manufacturing facility in order to enable the facility to manufacture the Product(s) in accordance 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 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 Buyer arises by the willful act or omission of Company (and 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 [***] 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 [***] of the [***] an amount equal to [***]. In the event that either (i) Company fails to [***], or (ii) supply of the 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 rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with 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 distribution 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) 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 (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, 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 contrary contained in USWM under this Agreement, in the event that Buyer shall make or have made Productincluding 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 12.02, Buyer shall be permitted 11.2.2(a) upon a Failure to disclose to any third party any Confidential Information Supply as is reasonably necessary a result of a Force Majeure event in connection accordance with such activities (subject to such third party agreeing in writing to be bound by the terms of Article 15 hereof), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the ManufacturerSection 12.10.

Failure to Supply. In the event 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 any of could adversely impact Patheon’s ability to supply the following occur: Products or (aiv) Manufacturer notifies Buyer Client properly rejects Products in accordance with Section 4.03 that Manufacturer will not be able 6.1(a) and such rejection materially adversely affects Client’s ability to fulfill Buyer’s Purchase Order as requested by Buyer sell the relevant Product, then in addition to, and which Purchase Order was requested in accordance with the terms herein (e.g.without limitation of, Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed any legal or equitable remedies available to Client as a result of Direct Supplier’s failure any breach of this Agreement by Patheon, all rights with respect to supply as described 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 Section 4.03(aconnection with having such Product (or replacement products) ; (b) Manufacturer fails manufactured and acquired, less the amount that Client would have paid to fulfill the Purchase Order in accordance Patheon hereunder for such Product had Patheon complied 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 other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with 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 distribution 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) 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 (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, 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 contrary contained in this Agreement, in the event that Buyer shall make or have made Product, pursuant to this Section 12.02, Buyer shall be permitted borne by Patheon and paid to disclose to any third party any Confidential Information as is reasonably necessary in connection with such activities Client within ten (subject to such third party agreeing in writing to be bound 10) days of demand therefor by the terms of Article 15 hereof), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the ManufacturerClient.

Failure to Supply. In If ICU fails to deliver, or anticipates that it will be unable to deliver, Products ordered pursuant to the event that terms 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 following occur: (a) Manufacturer notifies Buyer extent such failure to supply is a material breach, terminate this Agreement in accordance with Section 4.03 that Manufacturer will 13.3. ICU shall not be able deemed to fulfill Buyer’s Purchase Order as requested have failed to deliver under the preceding sentence if it is unable to manufacture Products ordered by Buyer and which Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed Hospira as a direct result of Direct Supplier’s Hospira's failure to supply ICU with Specified Components under Section 5.2 hereof or as described in Section 4.03(a) ; a direct result of Hospira's breach of its obligations under Sections 3.1(a), (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; or (c). If Hospira elects option (iii), ICU shall, if so requested by Hospira, (A) Buyer has sent Manufacturer a notice 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 component 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 can be timely supplied by ICU), thereby enabling Hospira or its designee to manufacture such quantities as Buyer shall request and in compliance with the delivery periods set forth Products, (B) reasonably assist Hospira or its designee in the applicable Purchase Order (whether due to transfer and the occurrence start-up of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”)manufacturing operations for such Products and make all necessary plans, then (i) immediately following such Failure to Supply Buyer mayformulations and manufacturing processes, in addition to any procedures, test methods, specialized test equipment, and other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with 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 distribution 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) 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 (v) Manufacturer shall make items available to Buyer Hospira or its Confidential designee, (C) grant Hospira or its designee access to ICU's regulatory files relating to such Products, (D) transfer all Regulatory Approvals to Hospira necessary to manufacture, market and sell such Products, and (E) supply such other technical and proprietary materials, 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 contrary contained in this Agreement, in the event that Buyer shall make or have made Product, pursuant to this Section 12.02, Buyer shall be permitted to disclose to any third party any Confidential Information regulatory assistance as is reasonably necessary in connection with requested by Hospira or its designee. ICU hereby grants to Hospira, without the necessity of any 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 activities Products. To the extent any know-how, technology, trade secrets or patent rights are owned, controlled or licensed by a Third Party (subject to such third party agreeing in writing to be bound by the terms of Article 15 hereof"Third Party Rights"), save and except are required to implement Hospira's right to manufacture or have manufactured such Products, ICU shall use its best efforts to obtain a license to all such Third Party Rights to allow Hospira or its designee to use such Third Party Rights for the direct labour (variable costs), fixed overhead costs and profit margins production of the ManufacturerProducts.

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 that any Ovamed fails (i) to satisfactorily supply at least [*******]% of the following occur: 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, (aii) Manufacturer notifies Buyer to substantially perform its obligations in connection with United States or other relevant Regulatory Approval of the Products and such failure has continued for more than [*******], or such longer period as reasonably necessary to cure such failure or such period required by the relevant Regulatory Approval authority, or (iii) to have adequate operational manufacturing facilities such that it is unable to manufacture Product, or unable to manufacture product in accordance with Specifications, 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 4.03 8.2.1 and (y) Collingwood has not, at the time, developed a commercial second source (on commercially reasonable terms) for a product that Manufacturer will not can be able substituted for the Product and that can meet the supply shortage resulting from Ovamed’s failure to fulfill Buyer’s Purchase Order supply, then, upon notice of such 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 Product in the Field of Use (the “Manufacturing IP”) (collectively, the “Manufacturing Failure License”), and such license shall be effective immediately upon notice of such election by Collingwood, and (b) Ovamed shall provide all assistance reasonably requested by Buyer and which Purchase Order was requested Collingwood to assist Collingwood or a third party acting on behalf of Collingwood in the manufacturing of the Product in accordance with the terms herein (e.g.Specifications, Buyer’s requested dates provided however, that Collingwood shall reimburse Ovamed for delivery any reasonable expenses it incurs in relation to its rendering of Purchase Orders must comply with the requirements in 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) such assistance; (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 other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with 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 distribution 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) 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 (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, 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 contrary contained 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 this Agreementeffect, in provided however, that Collingwood shall have the event that Buyer shall make right to use and have used all Manufacturing IP to manufacture or have made Product, pursuant to this Section 12.02, Buyer manufactured Product during such period that Ovamed is engaged in such remediation. Such plan shall be permitted delivered to disclose Collingwood within 30 days after the failure occurred. Collingwood may terminate this Agreement immediately, without penalty or further obligation to any third party any Confidential Information as is reasonably necessary in connection with Ovamed, if Ovamed fails to achieve remediation within such activities (subject [*******] period and Collingwood shall immediately be entitled to such third party agreeing in writing to be bound by the terms of Article 15 hereof), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the ManufacturerManufacturing Failure License.