Compliance by Neurocrine Sample Clauses

Compliance by Neurocrine. Neurocrine covenants that all activities undertaken by Neurocrine in collaborating with Taisho hereunder will comply with all applicable statutes, regulations and guidance of any Governmental Authorities relating to the Development and/or Commercialization of Products.
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Compliance by Neurocrine. Neurocrine covenants to comply with all applicable statutes, regulations and guidance of any Governmental Authorities relating to the Development and/or Commercialization of Products in the Neurocrine Territory.

Related to Compliance by Neurocrine

  • Compliance Audit LEA shall have the right but shall be under no obligation to conduct audit(s), from time to time, of Provider’s records concerning its compliance obligations as set forth in this Article V. Provider shall make such records and other documents available to LEA upon request.

  • Compliance Verification (a) The sub recipient shall periodically interview a sufficient number of employees entitled to DB prevailing wages (covered employees) to verify that contractors or subcontractors are paying the appropriate wage rates. As provided in 29 CFR 5.6(a)(6), all interviews must be conducted in confidence. The sub recipient must use Standard Form 1445 (SF 1445) or equivalent documentation to memorialize the interviews. Copies of the SF 1445 are available from EPA on request. (b) The sub recipient shall establish and follow an interview schedule based on its assessment of the risks of noncompliance with DB posed by contractors or subcontractors and the duration of the contract or subcontract. Sub recipients must conduct more frequent interviews if the initial interviews or other information indicated that there is a risk that the contractor or subcontractor is not complying with DB. Sub recipients shall immediately conduct interviews in response to an alleged violation of the prevailing wage requirements. All interviews shall be conducted in confidence." (c) The sub recipient shall periodically conduct spot checks of a representative sample of weekly payroll data to verify that contractors or subcontractors are paying the appropriate wage rates. The sub recipient shall establish and follow a spot check schedule based on its assessment of the risks of noncompliance with DB posed by contractors or subcontractors and the duration of the contract or subcontract. At a minimum, if practicable, the sub recipient should spot check payroll data within two weeks of each contractor or subcontractor’s submission of its initial payroll data and two weeks prior to the completion date the contract or subcontract. Sub recipients must conduct more frequent spot checks if the initial spot check or other information indicates that there is a risk that the contractor or subcontractor is not complying with DB. In addition, during the examinations the sub recipient shall verify evidence of fringe benefit plans and payments there under by contractors and subcontractors who claim credit for fringe benefit contributions. (d) The sub recipient shall periodically review contractors and subcontractor’s use of apprentices and trainees to verify registration and certification with respect to apprenticeship and training programs approved by either the U.S Department of Labor or a state, as appropriate, and that contractors and subcontractors are not using disproportionate numbers of, laborers, trainees and apprentices. These reviews shall be conducted in accordance with the schedules for spot checks and interviews described in Item 5(b) and (c) above. • (e) Sub recipients must immediately report potential violations of the DB prevailing wage requirements to the EPA DB contact listed above and to the appropriate DOL Wage and Hour District Office listed at xxxx://xxx.xxx.xxx/whd/america2.htm. “Contractor shall comply with all applicable standards, orders, or requirements issued under section 306 of the Clean Air Act (42 U.S.C. 1857(h)), section 508 of the Clean Water Act (33 • U.S.C. 1368), Executive Order 11738, and Environmental Protection Agency regulations (40 CFR part 15). (Awards to Contractors and Subcontractors in Excess of $100,000) The undersigned certifies, to the best of his or her knowledge and belief, that: (1) No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan or cooperative agreement. (2) If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, “Disclosure Form to Report Lobbying,” in accordance with its instructions. (3) The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans, and cooperative agreements) and that all subrecipients shall certify and disclose accordingly. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. Title Date

  • Compliance Audits D. 4.1 Compliance Audit(s). Without limiting the generality of section A.7.4 (Records Review), if requested by the Province from time to time, which request shall be at the Province’s sole discretion, the Recipient, at its own expense, will forthwith retain an independent third party auditor to conduct one or more compliance audits of the Recipient or any Project. The audit will be conducted in accordance with Canadian Generally Accepted Auditing Standards, as adopted by the Canadian Institute of Chartered Accountants, applicable as of the date on which a record is kept or required to be kept under such standards. In addition, the audit will assess the Recipient’s compliance with the terms of the Agreement and will address, with respect to each Project, without limitation, the following: (a) whether the Funds were spent in accordance with the Agreement and with due regard to economy, efficiency, and effectiveness; (b) the Project’s progress or state of completion; (c) whether the financial information the Recipient provided is complete, accurate, and timely, and in accordance with the Agreement; (d) whether the Recipient’s information and monitoring processes and systems are adequate to identify, capture, validate, and monitor the achievement of intended benefits of the Project; (e) the overall management and administration of the Project; (f) recommendations for improvement or redress; and (g) whether prompt and timely corrective action is taken on prior audit findings.

  • HIPAA Compliance If this Contract involves services, activities or products subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Contractor covenants that it will appropriately safeguard Protected Health Information (defined in 45 CFR 160.103), and agrees that it is subject to, and shall comply with, the provisions of 45 CFR 164 Subpart E regarding use and disclosure of Protected Health Information.

  • Compliance Review During the Term, Developer agrees to permit the GLO, HUD, and/or a designated representative of the GLO or HUD to access the Property for the purpose of performing Compliance-Monitoring Procedures. In accordance with GLO Compliance-Monitoring Procedures, the GLO or HUD will periodically monitor and audit Developer’s compliance with the requirements of this Agreement, the CDBG-DR Regulations, the CDBG Multifamily Rental Housing Guidelines, and any and all other Governmental Requirements during the Term. In conducting any compliance reviews, the GLO or HUD will rely primarily on information obtained from Developer’s records and reports, on-site monitoring, and audit reports. The GLO or HUD may also consider other relevant information gained from other sources, including litigation and citizen complaints. 5.04 HAZARDOUS MATERIALS: INDEMNIFICATION (a) Developer agrees to the following. (i) Developer shall not receive, store, dispose, or release any Hazardous Materials on or to the Property; transport any Hazardous Materials to or from the Property; or permit the existence of any Hazardous Material contamination on the Property. (ii) Developer shall give written notice to the GLO immediately when Developer acquires knowledge of the presence of any Hazardous Material on the Property; the transport of any Hazardous Materials to or from the Property; or the existence of any Hazardous Material contamination on the Property, with a full description thereof. (iii) Developer will promptly, at Developer’s sole cost and expense, comply with any Governmental Requirements regarding the removal, treatment, or disposal of such Hazardous Materials or Hazardous Material contamination and provide the GLO with satisfactory evidence of such compliance. (iv) Developer shall provide the GLO, within thirty (30) days of demand by the GLO, financial assurance evidencing to the GLO that the necessary funds are available to pay for the cost of removing, treating, and disposing of such Hazardous Materials or Hazardous Material contamination and discharging any assessments that may be established on the Property as a result thereof. (v) Developer shall insure that all leases, licenses, and agreements of any kind (whether written or oral) now or hereafter executed that permit any party to occupy, possess, or use in any way the Property or any part thereof include an express prohibition on the disposal or discharge of any Hazardous Materials at the Property and a provision stating that failure to comply with such prohibition shall expressly constitute a default under any such agreement. (vi) Developer shall not cause or suffer any liens (including any so-called state, federal, or local “Superfund” lien relating to such matters) to be recorded against the Property as a consequence of, or in any way related to, the presence, remediation, or disposal of Hazardous Materials in or about the Property. (b) DEVELOPER SHALL, AT ALL TIMES, RETAIN ANY AND ALL LIABILITIES ARISING FROM THE PRESENCE, HANDLING, TREATMENT, STORAGE, TRANSPORTATION, REMOVAL, OR DISPOSAL OF HAZARDOUS MATERIALS ON THE PROPERTY. REGARDLESS OF WHETHER ANY EVENT OF DEFAULT OCCURS OR CONTINUES, WHETHER THE GLO EXERCISES ANY REMEDIES IN RESPECT TO THE PROPERTY, OR SUCH SITUATION RELATED TO HAZARDOUS MATERIALS WAS CAUSED BY OR WITHIN THE CONTROL OF DEVELOPER OR THE GLO, DEVELOPER SHALL DEFEND, INDEMNIFY, AND HOLD HARMLESS THE GLO AND ITS OFFICERS, AGENTS, AND EMPLOYEES FROM AND AGAINST ANY AND ALL LIABILITIES, SUITS, ACTIONS, CLAIMS, DEMANDS, PENALTIES, DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, CONSEQUENTIAL DAMAGES, INTEREST, PENALTIES, FINES, AND MONETARY SANCTIONS), LOSSES, COSTS, AND EXPENSES (INCLUDING, WITHOUT LIMITATION, REASONABLE ATTORNEYS’ FEES AND COSTS) THAT MAY: (i) NOW OR IN THE FUTURE (WHETHER BEFORE OR AFTER THE CULMINATION OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT) BE INCURRED OR SUFFERED BY THE GLO BY REASON OF, RESULTING FROM, IN CONNECTION WITH, OR ARISING IN ANY MANNER WHATSOEVER FROM THE BREACH OF ANY WARRANTY OR COVENANT IN THIS SECTION OR THE INACCURACY OF ANY REPRESENTATION OF DEVELOPER IN RELATION TO THIS AGREEMENT;

  • CEQA Compliance The District has complied with all assessment requirements imposed upon it by the California Environmental Quality Act (Public Resource Code Section 21000 et seq. (“CEQA”) in connection with the Project, and no further environmental review of the Project is necessary pursuant to CEQA before the construction of the Project may commence.

  • PUBLIC RECORDS COMPLIANCE (APPLICABLE FOR SERVICE CONTRACTS Orange County is a public agency subject to Chapter 119, Florida Statutes. The Contractor agrees to comply with Florida’s Public Records Law. Specifically, the Contractor shall: 1. Keep and maintain public records required by Orange County to perform the service. 2. Upon request from Orange County’s custodian of public records, provide Orange County with a copy of the requested records or allow the records to be inspected or copied within a reasonable time at a cost that does not exceed the cost provided in this chapter or as otherwise provided by law. 3. Ensure that public records that are exempt or confidential and exempt from the public records disclosure requirements are not disclosed except as authorized by law for the duration of the contract term and following completion of the contract if the Contractor does not transfer the records to Orange County. 4. Upon completion of the contract, Contractor agrees to transfer at no cost to Orange County all public records in possession of the Contractor or keep and maintain public records required by Orange County to perform the service. If the Contractor transfers all public record to Orange County upon completion of the contract, the Contractor shall destroy any duplicate public records that are exempt or confidential and exempt from public records disclosure requirements. If the Contractor keeps and maintains public records upon completion of the contract, the Contractor shall meet all applicable requirements for retaining public records. All records stored electronically must be provided to Orange County, upon request from Orange County’s custodian of public records, in a format that is compatible with the information technology systems of Orange County. 5. A Contractor who fails to provide the public records to Orange County within a reasonable time may be subject to penalties under section 119.10, Florida Statutes. 6. IF THE CONTRACTOR HAS QUESTIONS REGARDING THE APPLICATION OF CHAPTER 119, FLORIDA STATUTES, TO THE CONTRACTOR’S DUTY TO PROVIDE PUBLIC RECORDS RELATING TO THIS CONTRACT, CONTACT THE CUSTODIAN OF PUBLIC RECORDS AT : Procurement Public Records Liaison

  • OSHA Compliance To the extent applicable to the services to be performed under this Agreement, Contractor represents and warrants, that all articles and services furnished under this Agreement meet or exceed the safety standards established and promulgated under the Federal Occupational Safety and Health Law (Public Law 91-596) and its regulations in effect or proposed as of the date of this Agreement.

  • Policy Compliance Violations The Requester and Approved Users acknowledge that the NIH may terminate the DAR, including this Agreement and immediately revoke or suspend access to all controlled-access datasets subject to the NIH GDS Policy at any time if the Requester is found to be no longer in agreement with the principles outlined in the NIH GDS Policy, the terms described in this Agreement, or the Genomic Data User Code of Conduct. The Requester and PI agree to notify the NIH of any violations of the NIH GDS Policy, this Agreement, or the Genomic Data User Code of Conduct data within 24 hours of when the incident is identified. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. The Requester and PI agree to notify the appropriate DAC(s) of any unauthorized data sharing, breaches of data security, or inadvertent data releases that may compromise data confidentiality within 24 hours of when the incident is identified. As permitted by law, notifications should include any known information regarding the incident and a general description of the activities or process in place to define and remediate the situation fully. Within 3 business days of the DAC notification(s), the Requester agrees to submit to the DAC(s) a detailed written report including the date and nature of the event, actions taken or to be taken to remediate the issue(s), and plans or processes developed to prevent further problems, including specific information on timelines anticipated for action. The Requester agrees to provide documentation verifying that the remediation plans have been implemented. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. NIH, or another entity designated by NIH may, as permitted by law, also investigate any data security incident or policy violation. Approved Users and their associates agree to support such investigations and provide information, within the limits of applicable local, state, tribal, and federal laws and regulations. In addition, Requester and Approved Users agree to work with the NIH to assure that plans and procedures that are developed to address identified problems are mutually acceptable and consistent with applicable law.

  • FERPA Compliance In connection with all FERPA Records that Contractor may create, receive or maintain on behalf of University pursuant to the Underlying Agreement, Contractor is designated as a University Official with a legitimate educational interest in and with respect to such FERPA Records, only to the extent to which Contractor (a) is required to create, receive or maintain FERPA Records to carry out the Underlying Agreement, and (b) understands and agrees to all of the following terms and conditions without reservation:

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