Product Non-Conformance and Remedies Sample Clauses

Product Non-Conformance and Remedies. If the parties agree or if determined in accordance with Section 6.7, that a Batch is [***], then Cognate will (with respect to such Batch of [***] or a subsequent Batch Manufactured to replace a Batch of [***] that is [***]), at Cognate’s option and as Asterias’s sole remedy, either: (a) if possible and compliant with cGMP, the Specifications and other Applicable Law, rework or reprocess the [***] so that such Batch conforms to the Specifications (and qualifies as having been Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process) as soon as reasonably possible [***]; or (b) as soon as reasonably practicable, Manufacture a new Batch without charging Asterias [***] such new Batch. If a Batch is patient-specific and requires leukapheresis of the applicable patient to Manufacture such new Batch, Asterias shall [***]. In addition, [***] as described above [***] with respect to the [***] for such patient-specific Batch; provided, however, that [***]. For clarity, Asterias’ right to receive the foregoing remedies applies with respect to any Batch Manufactured and any subsequent Batch Manufactured or reprocessed or reworked to replace a previously Manufactured Batch that was [***]. Nothing in this Section 6.4 will eliminate or reduce Asterias’s liability under this Agreement (except as expressly provided for in other provisions of this Agreement or any SOW) for fees, costs or expenses associated with the Manufacture of any Batch in accordance with the provisions of this Agreement and any SOW, and Asterias will be responsible for payment in full of all amounts payable under this Agreement, together with all amounts payable under the relevant provisions of any applicable SOW in respect of such Batch.
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Product Non-Conformance and Remedies. (a) If a Batch of Product Manufactured is a Non-Conforming Batch, then:
Product Non-Conformance and Remedies. If any Product is agreed by the Parties, or is determined in accordance with Section 2.7.4., to be a Non-Conforming Product, EQ shall be liable to Akebia for such Non-Conforming Product; provided that (except in respect to Third Party claims, which shall be subject to the provisions of Section 9 below) EQ's liability shall be limited to, at Akebia’s option, (i) refunding in full the Price paid by Akebia for the Non-Conforming Product, including the cost of Akebia Materials used in the Manufacture of such Non-Conforming Product; or (ii) at EQ’s cost and expense, supply to Akebia Product that is not Non-Conforming Product (in the same quantity as the Product that has been agreed by the Parties to be Non-Conforming Product) as soon as reasonably possible; or (iii) if possible according to Applicable Law and cGMP, reworking or reprocessing the Non-Conforming Product, at EQ’s cost and expense, so that the Non-Conforming Product conforms to Specifications. Notwithstanding the foregoing, should EQ provide Non-Conforming Product that, after a diligent quality investigation performed in accordance with cGMP, the Quality Agreement, and industry good practices, are attributable, in whole or in part, to EQ’s failure to comply with cGMP, the Quality Agreement, or their obligations under this Agreement, EQ shall be responsible, up to the amounts indicated in Section 9.5 hereof, for the resulting costs and expenses to Akebia, including, without limitation, the costs of any resulting recall, expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock of Product, the cost of notifying customers, the costs associated with shipment and destruction of recalled drug product containing the Product from customers, and replacement Product equal to the amount of Product found to contain the Non-Conformity. EQ shall not be responsible for the costs associated with any Non-Conforming Product that has been detected by Akebia and Akebia fails to communicate it to EQ within [**], or if Akebia (or the Third Party that receives the Product supplied by EQ on behalf of Akebia) fails to appropriately and timely perform the tests, analysis, inspections and/or reviews of the Product, and/or complete its related documentation required under Applicable Laws, the Quality Agreement, and/or industry good practices.

Related to Product Non-Conformance and Remedies

  • Specific Performance and Remedies Shareholder acknowledges that it will be impossible to measure in money the damage to Parent if Shareholder fails to comply with the obligations imposed by this Agreement and that, in the event of any such failure, Parent will not have an adequate remedy at law or in equity. Accordingly, Shareholder agrees that injunctive relief or other equitable remedy, in addition to remedies at law or in damages, is the appropriate remedy for any such failure and will not oppose the granting of such relief on the basis that Parent has an adequate remedy at law. Shareholder agrees that Shareholder will not seek, and agrees to waive any requirement for, the securing or posting of a bond in connection with Parent’s seeking or obtaining such equitable relief. In addition, after discussing the matter with Shareholder, Parent shall have the right to inform any third party that Parent reasonably believes to be, or to be contemplating, participating with Shareholder or receiving from Shareholder assistance in violation of this Agreement, of the terms of this Agreement and of the rights of Parent hereunder, and that participation by any such persons with Shareholder in activities in violation of Shareholder’s agreement with Parent set forth in this Agreement may give rise to claims by Parent against such third party.

  • Disputes and Remedies 6.01 Agreement of the Parties The Parties agree that the interests of fairness, efficiency, and good business practices are best served when the Parties employ all reasonable and informal means to resolve any dispute under the Contract before resorting to formal dispute resolution processes otherwise provided in the Contract. The Parties will use all reasonable and informal means of resolving disputes prior to invoking a remedy provided elsewhere in the Contract, unless HHSC immediately terminates the Contract in accordance with the terms and conditions of the Contract. Any dispute, that in the judgment of any Party to the Agreement, may materially affect the performance of any Party will be reduced to writing and delivered to the other Party within 10 business days after the dispute arises. The Parties must then negotiate in good faith and use every reasonable effort to resolve the dispute at the managerial or executive levels prior to initiating formal proceedings pursuant to the UTC and Texas Government Code §2260, unless a Party has reasonably determined that a negotiated resolution is not possible and has so notified the other Party. The resolution of any dispute disposed of by agreement between the Parties will be reduced to writing and delivered to all Parties within 10 business days of such resolution.

  • Waiver and Non-Exclusion of Remedies Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.

  • Breach and Remedies If Seller discovers or is notified of a security breach or potential security breach based on the restrictions contained in this article (“Security Breach”), Seller immediately shall: (i) cease access to any Proprietary Information and Materials that are the subject of the Security Breach and shall not review any Unauthorized Proprietary Information and Materials; (ii) provide notice to Buyer, including notice of the materials involved in the Security Breach, by sending notice to xxxxx@xxxxxx.xxx and to Buyer’s Authorized Procurement Representative for this Contract; and (iii) assist Xxxxx in investigating, remedying, and taking any other action Buyer deems necessary to address such Security Breach, including related to any dispute, inquiry, or claim related to such Security Breach. Seller agrees to permit Buyer to review its security control procedures and practices via physical or electronic access by Buyer, including access to Seller facilities in which such systems are located, as well as any and all premises where maintenance, storage or backup activities are performed. Any material breach of this article by Seller may be considered a default for which Buyer may suspend Electronic Access and/or cancel this Contract, and any other contracts between Buyer and Seller, in accordance with the "Cancellation for Default" article of this Contract. Further, Seller acknowledges that any attempts by Seller or any Seller Personnel to circumvent any security measures designed to prevent unauthorized access to the Boeing Systems may be subject to criminal or civil penalties under the U.S. Federal Computer Fraud and Abuse Act and other applicable laws and regulations.

  • Termination and Remedies (a) In the event that the Purchaser defaults or fails to perform any of the terms and conditions contained in this Purchase Agreement, or assigns this Agreement without the Vendor’s consent, the Purchaser’s Deposit (including any portion of the Deposit bonded by the Purchaser under the terms of this Agreement) shall immediately be forfeited to the Vendor. Such forfeiture shall not be deemed to be liquidated damages, and shall not preclude further claims by the Vendor against the Purchaser for any and all remedies available at law and at equity, including but not limited to damages arising from the Purchaser’s breach and/or specific performance. (b) In the event that the Purchaser defaults or fails to perform any of the terms and conditions contained in this Purchase Agreement and the Purchaser’s Deposit (including any portion of the Deposit bonded by the Purchaser under the terms of this Agreement) is forfeited to the Vendor, the Vendor’s damages arising from the Purchaser’s breach shall be deemed to be at least equal to the forfeited Deposit without restricting the right of the Vendor to xxx for additional damages and/or specific performance. (c) In the event that the Purchaser defaults or fails to perform any of the terms and conditions contained in this Purchase Agreement and the Vendor takes steps to enforce the terms and conditions of this Purchase Agreement, or commences or defends any action for the judicial interpretation, enforcement, termination, cancellation or rescission hereof or for damages for the breach hereof, the Vendor, in the event it is successful in such action, shall be entitled to solicitor and client costs on a full indemnity basis. (d) In the event that the Vendor, in its sole discretion, determines that the Purchaser is behaving in an unreasonable, disruptive or unruly manner either by action or inaction, or that the Vendor cannot meet the expectations of the Purchaser, the Vendor may unilaterally terminate this Purchase Agreement. In the event that the Vendor is unable to perform the scope of work as specified in this Purchase Agreement for reasons beyond the control of the Vendor, the Vendor may terminate this Purchase Agreement. Upon termination of this Purchase Agreement pursuant to this subclause, the Vendor will return all Deposits to the Purchaser, without interest, after deducting any reasonable and necessary expenses incurred by the Vendor prior to cancellation, including, but not limited to, taxes, utilities, interest and other carrying costs. (e) In the event that the Vendor defaults or fails to perform any of the terms and conditions contained in this Purchase Agreement, then the Deposit paid by the Purchaser under the terms of this Purchase Agreement, together with any accrued interest thereon, will be paid by the Vendor to the Purchaser and the Purchaser will have no further claim against the Vendor.

  • Landlord Remedies Upon the occurrence and during the continuance of a Tenant Event of Default but subject to the provisions of Article XVII, Landlord may, subject to the terms of Section 16.3 below, do any one or more of the following: (x) terminate this Lease by giving Tenant no less than ten (10) days’ notice of such termination and the Term shall terminate and all rights and obligations of Tenant under this Lease shall cease, subject to any provisions that expressly survive the Expiration Date, (y) seek damages as provided in Section 16.3 hereof or (z) except to the extent expressly otherwise provided under this Lease, exercise any other right or remedy hereunder, at law or in equity available to Landlord as a result of any Tenant Event of Default. Tenant shall pay as Additional Charges all costs and expenses incurred by or on behalf of Landlord, including reasonable and documented attorneys’ fees and expenses, as a result of any Tenant Event of Default hereunder. Subject to Article XIX, Article XXXVI and Section 17.1(f) hereof, at any time upon or following the Expiration Date, Tenant shall, if required by Landlord to do so, immediately surrender to Landlord possession of the Leased Property and quit the same and Landlord may enter upon and repossess such Leased Property by reasonable force, summary proceedings, ejectment or otherwise, and may remove Tenant and all other Persons and any of Tenant’s Property therefrom. (a) None of (i) the termination of this Lease, (ii) the repossession of the Leased Property, (iii) the failure of Landlord to relet the Leased Property or any portions thereof, (iv) the reletting of all or any portion of the Leased Property, or (v) the inability of Landlord to collect or receive any rentals due upon any such reletting, shall relieve Tenant of its liabilities and obligations hereunder, all of which shall survive any such termination, repossession or reletting. Landlord and Tenant agree that Landlord shall have no obligation to mitigate Landlord’s damages under this Lease. (b) If this Lease shall terminate pursuant to Section 16.2(x) or if Landlord shall obtain a court order permitting reentry following the occurrence of a Tenant Event of Default that is continuing, then, in any such event, Landlord or Landlord’s agents and employees may immediately or at any time thereafter reenter the Leased Property to the extent permitted by law (including applicable Gaming Regulations), either by summary dispossess proceedings or by any suitable action or proceeding at law, without being liable to indictment, prosecution or damages therefor, and may repossess the same, and may remove any Person therefrom, to the end that Landlord may have, hold and enjoy the Leased Property. The words “enter,” “reenter,” “entry” and “reentry,” as used herein, are not restricted to their technical legal meanings.

  • Waiver and Remedies The parties may (a) extend the time for performance of any of the obligations or other acts of any other party to this Agreement, (b) waive any inaccuracies in the representations and warranties of any other party to this Agreement contained in this Agreement or in any certificate, instrument or document delivered pursuant to this Agreement or (c) waive compliance with any of the covenants, agreements or conditions for the benefit of such party contained in this Agreement. Any such extension or waiver by any party to this Agreement will be valid only if set forth in a written document signed on behalf of the party or parties against whom the waiver or extension is to be effective. No extension or waiver will apply to any time for performance, inaccuracy in any representation or warranty, or noncompliance with any covenant, agreement or condition, as the case may be, other than that which is specified in the written extension or waiver. No failure or delay by any party in exercising any right or remedy under this Agreement or any of the documents delivered pursuant to this Agreement, and no course of dealing between the parties, operates as a waiver of such right or remedy, and no single or partial exercise of any such right or remedy precludes any other or further exercise of such right or remedy or the exercise of any other right or remedy. Any enumeration of a party’s rights and remedies in this Agreement is not intended to be exclusive, and a party’s rights and remedies are intended to be cumulative to the extent permitted by law and include any rights and remedies authorized in law or in equity.

  • Tenant’s Remedies Notwithstanding any other provision of this Lease, if any default hereunder by Landlord is not cured within the applicable cure period provided in Paragraph 20(c) or any other applicable cure period provided in this Lease (including any Mortgagee’s additional cure period), Tenant’s exclusive remedies shall be (i) an action for specific performance, or (ii) an action for actual damages. Notwithstanding any other provision of this Lease, the liability of Landlord to Tenant for any breach or default by Landlord under the terms of this Lease, or for any other matter related to this Lease or to the Premises or Project, shall be limited to Tenant’s actual direct, but not consequential, damages therefor, and any judgment against Landlord in connection therewith shall be recoverable only from the interest of Landlord in the Buildings. Tenant hereby waives any claim for damages for any disturbance, loss of business, nuisance, injury or inconvenience to or interference with Tenant’s business, any loss of occupancy or quiet enjoyment of the Premises, and any other loss arising from Landlord’s entry and acts pursuant to Paragraph 18 or otherwise with respect to any act, omission or breach of Landlord. Without limiting the preceding sentence, in no event shall Landlord be liable to Tenant for any consequential damages, including, without limitation, any losses arising from any interruption of Tenant’s business, or for lost profits, or for charges or expenses which continue but would have been earned if the business had gone on without interruption, or for any other loss, claim, cost, expense or damage which would be covered by a standard policy of business interruption insurance. Landlord, or if Landlord is a partnership its partners whether general or limited, or if Landlord is a corporation its directors, officers or shareholders, or if Landlord is a limited liability company its members or managers, shall never be personally liable for any such judgment. Any lien obtained to enforce such judgment and any levy of execution thereon shall be subject and subordinate to any Mortgage (excluding any Mortgage which was created as part of an effort to defraud creditors, i.e., a fraudulent conveyance); provided, however that any such judgment and any such levy of execution thereon shall not be subject or subordinated to any Mortgage that is created or recorded in the official records of the county in which the Project is located after the date of the judgment giving rise to such lien. Landlord’s interest in the Buildings shall include any insurance proceeds received by Landlord which are not controlled by any Mortgagee or other lender. Tenant hereby waives the benefit of any Laws granting it (A) the right to perform Landlord’s obligations, or (B) the right to terminate this Lease or withhold Rent on account of any Landlord default, including, without limitation, Sections 1932(1), 1941 and 1942 of the California Civil Code.

  • Waivers and Remedies The waiver by any of the parties hereto of any other party's prompt and complete performance, or breach or violation, of any provision of this Agreement shall not operate nor be construed as a waiver of any subsequent breach or violation, and the waiver by any of the parties hereto to exercise any right or remedy which it may possess hereunder shall not operate nor be construed as a bar to the exercise of such right or remedy by such party upon the occurrence of any subsequent breach or violation.

  • Termination Remedies (a) If all conditions precedent to the obligations of Buyer set forth in Article VII, or of Seller set forth in Article VIII, (such Party that has satisfied its conditions precedent, the “Performing Party”) have been met and the transactions contemplated by this Agreement are not consummated on or before the Closing Date because of the failure of Buyer or Seller to perform any of its material obligations hereunder or the breach of any representation herein by Buyer or Seller (such party that has not satisfied its conditions precedent, the “Breaching Party”) and the Performing Party has performed all of its material obligations hereunder and has not breached any representation herein, then in such event, the Performing Party shall have the option to terminate this Agreement, in which case (i) if Buyer is the Breaching Party, Seller shall retain the Deposit as liquidated damages on account of Buyer’s failure to perform its obligations under this Agreement or Buyer’s breach of any representation under this Agreement, which remedy shall be the sole and exclusive remedy available to Seller for Buyer’s breaches or (ii) if Seller is the Breaching Party, then Seller shall return the Deposit to Buyer in immediately available funds within three (3) calendar days after receipt of Buyer’s notice of termination. Buyer and Seller acknowledge and agree that (i) the Seller’s actual damages upon the event of such a termination are difficult to ascertain with any certainty, (ii) that the Deposit is a reasonable estimate of such actual damages and (iii) such liquidated damages do not constitute a penalty. Additionally, if Seller is the Breaching Party, in lieu of terminating this Agreement, Buyer shall have the right of specific performance of this Agreement. (b) If this Agreement is terminated for any reason, other than as set forth in Section 11.03(a), then Seller shall return the Deposit to Buyer in immediately available funds within three (3) calendar days after the event giving rise to such payment to Buyer. Buyer and Seller shall thereupon have the rights and obligations set forth elsewhere herein.

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