Drug Product Non-Compliance and Remedies Sample Clauses

Drug Product Non-Compliance and Remedies. Subject to Sections 7.11 and 7.13, if a Batch of Drug Product contains a Defect caused by a Brammer Failure as determined by an investigation, Brammer will at Customer’s election: (i) [**] [**]
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Drug Product Non-Compliance and Remedies. If a Lot of Drug Product contains a Defect caused by a Brammer Failure as determined in accordance with Section 5.3, Brammer will at Customer’s election: (i) at [**] cost and expense (excluding (a) [**] percent ([**]%) of the normal cost to manufacture Drug Substance if different Lots of Drug Substance were pooled to manufacture such Lot of Drug Product or [**] percent ([**]%) of the normal cost to manufacture Drug Substance if Batches or Lots of Product were not pooled to manufacture such Lot of Drug Product, and (b) the cost of any additional Product Materials necessary for the supply of any Drug Substance that must be replaced therefor and the cost of any other additional Product Materials necessary for manufacture of the new Lot of Drug Product) and as soon as practicable, manufacture a new Lot of Drug Product, taking into account the availability of Product Materials; or (ii) if reasonably possible and acceptable to Customer for its purposes, Reprocess or Rework the Lot of Drug Product, at [**] cost and expense (except for the supply of any additional Product Materials that must be replaced therefor) and as soon as practicable, so that the Lot of Drug Product can be deemed to have been manufactured in compliance with cGMP and the Process, and to conform to Specifications. The sole and exclusive remedies available to Customer with respect to the replacement, Reworking or Reprocessing of a non-conforming Lot of Drug Product resulting from a Defect caused by a Brammer Failure are set forth in this Section 5.8; provided, however, that nothing in this Section 5.8 shall limit or otherwise restrict Customer’s other rights and remedies under this Agreement, including with respect to a Brammer breach of the terms of this Agreement.

Related to Drug Product Non-Compliance and Remedies

  • Investigations and Remediations Lessor shall retain the responsibility and pay for any investigations or remediation measures required by governmental entities having jurisdiction with respect to the existence of Hazardous Substances on the Premises prior to the Start Date, unless such remediation measure is required as a result of Lessee's use (including "Alterations", as defined in Paragraph 7.3(a) below) of the Premises, in which event Lessee shall be responsible for such payment. Lessee shall cooperate fully in any such activities at the request of Lessor, including allowing Lessor and Lessor's agents to have reasonable access to the Premises at reasonable times in order to carry out Lessor's investigative and remedial responsibilities.

  • 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.

  • Performance and Compliance with Collateral The Borrower will, at the Borrower’s expense, timely and fully perform and comply (or, by exercising its rights thereunder, cause the Seller to perform and comply pursuant to the Sale Agreement) with all provisions, covenants and other promises required to be observed by it under the Collateral, the Transaction Documents and all other agreements related to such Collateral.

  • Penalties for Non-compliance to Service Level Agreement Where the Supplier/Service Provider fails to deliver the Goods/Services within the agreed and accepted milestone timelines and provided that the cause of the delay was not due to a fault of Transnet, penalties shall be imposed at …………………………………………………… .

  • Incident Notice and Remediation If Contractor becomes aware of any Incident, it shall notify the State immediately and cooperate with the State regarding recovery, remediation, and the necessity to involve law enforcement, as determined by the State. Unless Contractor can establish that none of Contractor or any of its agents, employees, assigns or Subcontractors are the cause or source of the Incident, Contractor shall be responsible for the cost of notifying each person who may have been impacted by the Incident. After an Incident, Contractor shall take steps to reduce the risk of incurring a similar type of Incident in the future as directed by the State, which may include, but is not limited to, developing and implementing a remediation plan that is approved by the State at no additional cost to the State.

  • Compliance with Accessibility Standards All parties to this Agreement shall ensure that the plans for and the construction of all projects subject to this Agreement are in compliance with standards issued or approved by the Texas Department of Licensing and Regulation (TDLR) as meeting or consistent with minimum accessibility requirements of the Americans with Disabilities Act (P.L. 101-336) (ADA).

  • 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.

  • 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.

  • 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.

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