Costs for Changes for Compliance with Specifications, Laws and Change Control Sample Clauses

Costs for Changes for Compliance with Specifications, Laws and Change Control. Payment for changes requested under Section 4.3 and 4.4, including those required for compliance with the Product Drug Application, Specifications, the Quality Agreement, cGMPs and Laws, will be made per the following standards: (a) The costs of changes requested by [ * ] in order to maintain the Specifications in conformity with that Product’s Drug Application, the Quality Agreement, cGMPs or Laws (including for any of the Materials used in that Product, capital expenditures required as a result of the change and specifically and exclusively used with that Product), and not generally applicable to the manufacture of pharmaceutical products or types of dosage forms (e.g., sterile vials or blister packs) generally, will be borne by [ * ]. (b) The costs of changes (including any capital expenditure incurred to implement any revision, Material costs and other one-time or recurrent expenditures) requested by [ * ] to maintain the Specifications in conformity with the Quality Agreement, cGMPs or Laws that are generally applicable to the manufacture of pharmaceutical products or applicable dosage form (e.g., sterile vials or tablets in blister packs) will be subject to agreement between the Parties including any resulting [ * ] in the price of that Product. (c) Prior to beginning any work for which [ * ] anticipates that [ * ] will be financially responsible per this Section 6.3, [ * ] will evaluate the estimated costs and timing of the potential revisions to the Specifications and provide [ * ] with a written estimate and timeline. [ * ] will reimburse [ * ] for its actual costs incurred with [ * ] prior written approval in implementing a change to the Specifications requested by XenoPort under Section 4.3(a), and [ * ] must provide such documentation of its costs as may be [ * ] by [ * ]. All costs incurred by [ * ] and reimbursed by [ * ] will not include any xxxx-up for any handling or storage. [ * ] agrees to [ * ] minimize its costs associated with any Specification change.
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Related to Costs for Changes for Compliance with Specifications, Laws and Change Control

  • COMPLIANCE WITH POLICIES AND PROCEDURES During the period that Executive is employed with the Company hereunder, Executive shall adhere to the policies and standards of professionalism set forth in the policies and procedures of the Company and IAC as they may exist from time to time.

  • 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 …………………………………………………… .

  • Execution of Change Orders Change Orders shall be signed by the Contractor, ordinarily certified by the Design Professional, and approved by the Owner in accordance with the form of Change Order prescribed by the Owner. No request for payment by the Contractor for a Change Order shall be due, nor shall any such request appear on an Application for Payment, until the Change Order is executed by the Owner. In the event of emergency (see Article

  • DECLARATION OF COMPLIANCE WITH APPLICABLE STANDARDS 1. Does the Work report experiments involving human subjects? [ ] YES [ ] NO  If Yes, were the reported experiments in accordance with the ethical standards of the committee responsible for human experimentation (institutional and national), and with the Helsinki Declaration of 1975, as revised in 2013 (xxxx://xxxxxx.xxx.xxx/ecodes/node/3931 )? [ ] YES [ ] NO (If Yes, the Assignor must submit a copy of the approval and consent-to-disclose form to Xxxxxxx Science Publishers by fax or email.) Please state whether Ethical Approval was given, by whom and the relevant Judgement’s reference number. (If No, the Assignor must mention an institutional or regional guideline.) 2. Does the Work report experiments involving animals? [ ] YES [ ] NO  If Yes, were the reported experiments in accordance with the standards set forth in one of below national guidelines and regulations: o The US National Research Council's "Guide for the Care and Use of Laboratory Animals," o The US Public Health Service's "Policy on Humane Care and Use of Laboratory Animals," and "Guide for the Care and Use of Laboratory Animals." o UK : the Animals (Scientific Procedures) Act 1986 Amendment Regulations (SI 2012/3039). [ ] YES [ ] NO 6 [v.122016] Conflicts of interest arise when authors, reviewers, or editors have interests (such as financial or personal interests) that are not made clear and that may influence their judgment on the content of their work. Authors and editors who submit work for publication with Xxxxxxx Science are required to disclose and acknowledge all forms of financial support relating to the work to be published, all commercial or financial involvement that might present an appearance of a conflict of interest in respect of the work, and all agreements relating to sponsorship of any research upon which the work is based. Are there any actual, or potential, conflicts of interest? [ ] YES [ ] NO If Yes, details of the actual or potential conflicts of interest must be set-out in the spaces provided below. Does Assignor require assistance in having the English grammar and style of the Work checked and improved by Xxxxxxx Science? [ ] YES [ ] NO If Yes, Xxxxxxx Science will provide a quote in respect of the same.

  • Performance of Services in Accordance with Regulatory Requirements; Furnishing of Books and Records In performing the services set forth in this Agreement, the Manager: A. shall conform with the 1940 Act and all rules and regulations thereunder, with all other applicable federal, state and foreign laws and regulations, with any applicable procedures adopted by the Trust’s Board of Trustees, and with the provisions of the Trust’s Registration Statement filed on Form N-1A as supplemented or amended from time to time; B. will make available to the Trust, promptly upon request, any of the Fund’s books and records as are maintained under this Agreement, and will furnish to regulatory authorities having the requisite authority any such books and records and any information or reports in connection with the Manager’s services under this Agreement that may be requested in order to ascertain whether the operations of the Trust are being conducted in a manner consistent with applicable laws and regulations.

  • Human and Financial Resources to Implement Safeguards Requirements The Borrower shall make available necessary budgetary and human resources to fully implement the EMP and the RP.

  • Review and Procedure Limitations The Asset Representations Reviewer will have no obligation (i) to determine whether a Delinquency Trigger has occurred, (ii) to determine whether the required percentage of Noteholders has voted to direct a Review, (iii) to determine which Receivables are subject to a Review, (iv) to obtain or confirm the validity of the Review Materials, (v) to obtain missing or insufficient Review Materials (except to the extent set forth in Section 3.04), or (vi) to take any action or cause any other party to take any action under any of the Basic Documents to enforce any remedies for breaches of any Eligible Representations. The Asset Representations Reviewer will only be required to perform the Tests provided in Exhibit A and will have no obligation to perform additional testing procedures on any ARR Receivables or to consider any additional information provided by any party. The Asset Representations Reviewer will have no obligation to provide reporting or information in addition to that described in Section 3.07. However, the Asset Representations Reviewer may review and report on additional information that it determines in good faith to be material to its performance under this ARR Agreement and may re-perform a Review with respect to an ARR Receivable as contemplated by Section 3.09. The Issuing Entity expressly agrees that the Asset Representations Reviewer is not advising the Issuing Entity or any Noteholder or any investor or future investor concerning the suitability of the Notes or any investment strategy. The Issuing Entity expressly acknowledges and agrees that the Asset Representations Reviewer is not an expert in accounting, tax, regulatory, or legal matters, and that the Asset Representations Reviewer is not providing legal advice as to any matter.

  • Implementation of Changes If Tenant: (i) approves in writing the cost or savings and the estimated extension in the time for completion of Landlord’s Work, if any, and (ii) deposits with Landlord any Excess TI Costs required in connection with such Change, Landlord shall cause the approved Change to be instituted. Notwithstanding any approval or disapproval by Tenant of any estimate of the delay caused by such proposed Change, the TI Architect’s determination of the amount of Tenant Delay in connection with such Change shall be final and binding on Landlord and Tenant.

  • 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).

  • Certain State Law Requirements for Contracts The contents of this Section are required by Texas Law and are included by County regardless of content. For purposes of Sections 2252.152, 2271.002, and 2274.002, Texas Government Code, as amended, C&T hereby verifies that C&T and any parent company, wholly owned subsidiary, majority-owned subsidiary, and affiliate: a. Unless affirmatively declared by the United States government to be excluded from its federal sanctions regime relating to Sudan or Iran or any federal sanctions regime relating to a foreign terrorist organization, is not identified on a list prepared and maintained by the Texas Comptroller of Public Accounts under Sections 806.051, 807.051, or 2252.153 of the Texas Government Code. b. If employing ten (10) or more full-time employees and this Agreement has a value of

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