Regulatory Agency Requirements Sample Clauses

Regulatory Agency Requirements. BIONICHE shall prepare and test the Drug Product in conformity with GMP. Subject to the allocation of responsibility for regulatory compliance as set forth in Paragraph 5.2, each party shall consult with the other party hereto before implementing additional regulatory agency requirements concerning the control of Drug Product components, manufacture of the Drug Product, or storage and handling of the Drug Product. The full text of regulatory agency requests or comments will be provided by the party receiving such requests or comments to the other party hereto. The parties will mutually agree on how to respond to such requests and comments and on the allocation of the costs thereof; provided that BIONICHE shall be entitled to reimbursement from CUMBERLAND for any out-of-pocket expenses or extraordinary costs previously approved in writing by CUMBERLAND and required in connection with implementing such regulatory requirements other than the ordinary costs of compliance with GMP.
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Regulatory Agency Requirements. FMC and FMER understand and acknowledge that SunTrust is subject to examination by a Governmental Authority with authority over SunTrust and its Affiliates. FMC and FMER agree to cooperate fully with any examination or inquiry by any such Governmental Authority at SunTrust’s expense. FMC and FMER further acknowledge that SunTrust, as a regulated financial institution, is required to engage in ongoing oversight of its relationship with FMC and FMER, including reviewing such Parties’ compliance with Privacy Requirements, insurance coverage, and performance under this Agreement. FMC and FMER agree to notify SunTrust promptly in writing in the event it experiences any material adverse change, including material financial difficulty, other catastrophic event, material change in strategic goals, or significant staffing changes relative to its obligations under this Agreement. With respect to audits and examinations related to the Program to be performed on FMC and/or FMER by a Governmental Authority with authority over SunTrust and its Affiliates, SunTrust shall provide FMC with as much prior written notice as reasonably practicable; provided, however, that the notice requirement of Section 12.3.1 shall not apply to any such audit or examination.
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Regulatory Agency Requirements. FAULDING shall prepare and test the Drug Product in conformity with GMP. Subject to the allocation of responsibility for regulatory compliance as set forth in Paragraph 5.2, each party shall consult with the other party hereto before implementing additional regulatory agency requirements concerning the control of Drug Product components, manufacture of the Drug Product, or storage and handling of the Drug Product. The full text of regulatory agency requests or comments will be provided by the party receiving such requests or comments to the other party hereto. The parties will mutually agree on how to respond to such requests and comments and on the allocation of the costs thereof; provided that FAULDING shall be liable only for its reasonable internal costs and not for any out-of-pocket expenses or extraordinary costs required in connection with implementing such regulatory requirements other than the ordinary costs of compliance with GMP.
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Regulatory Agency Requirements. Envestnet understands and acknowledges that FundQuest is subject to examination by any federal, state or local governmental or quasi-governmental officials with regulatory authority over FundQuest and its affiliates. Without relieving FundQuest’s requirement to maintain all books and records in accordance with the Securities Exchange Act of 1934, as amended, or by the Investment Advisers Act of 1940, as amended, and any other applicable regulations, Envestnet shall provide all reasonable assistance in connection with FundQuest meeting its obligations to any legal or regulatory authority (including, without limitation, any self-regulatory organizations, fund boards or securities exchanges). The requirements to provide all reasonable assistance in connection with FundQuest meeting its obligations to any legal or regulatory authority shall survive the Term of this Agreement for a period of five (5) years commencing at the end of the calendar year in which this Agreement is terminated or expires. Envestnet shall retain all relevant documentation in accordance with its established document retention policy, which is designed to comply with SEC document retention regulations. All reasonable costs and expenses, as agreed upon by the parties, incurred in connection with Envestnet’s servicing of such requests after termination or expiration of the Agreement shall be the responsibility of FundQuest.
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Regulatory Agency Requirements. Program Manager understands and acknowledges that Program Manager may be subject to examination by any federal, state or local governmental or quasi-governmental officials with regulatory authority over Lender and Lender’s affiliates. Program Manager agrees to cooperate fully with any examination or inquiry by any such officials or other regulatory body or agency. Program Manager further acknowledges that Lender, as agent for regulated financial institutions, is required to engage in ongoing oversight of its relationship with Program Manager, including, but not limited to, reviewing Program Manager’s financial conditions, compliance with privacy laws and regulations, insurance coverage, and performance under this Agreement. Program Manager agrees to notify Lender promptly in writing in the event it experiences any material adverse change, including but not limited to, material financial difficulty, other catastrophic event, material change in strategic goals, or significant staffing changes.
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Regulatory Agency Requirements. 1. Comply with state and local regulations governing use of paint materials.
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Regulatory Agency Requirements. FMC and FMER understand and acknowledge that Lender is subject to examination by a Governmental Authority with authority over Lender and its Affiliates. FMC and FMER agree to cooperate fully with any examination or inquiry by any such Governmental Authority at Lender’s expense. FMC and FMER further acknowledge that Lender, as a regulated financial institution, is required to engage in ongoing oversight of its relationship with FMC and FMER, including reviewing such Parties’ compliance with Privacy Requirements, insurance coverage, and performance under this Agreement. FMC and FMER agree to notify Lender promptly in writing in the event it experiences any material adverse change, including material financial difficulty, or catastrophic event relative to its obligations under this Agreement. With respect to audits and examinations related to the Programs to be performed on FMC and/or FMER by a Governmental Authority with authority over Lender and its Affiliates, Lender shall provide FMC with as much prior written notice as reasonably practicable; provided, however, that the notice requirement of Section 10.3.1 shall not apply to any such audit or examination.
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Regulatory Agency Requirements 
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Related to Regulatory Agency Requirements

  • Compliance with Regulatory Requirements Upon demand by Lender, Borrower shall reimburse Lender for Lender’s additional costs and/or reductions in the amount of principal or interest received or receivable by Lender if at any time after the date of this Agreement any law, treaty or regulation or any change in any law, treaty or regulation or the interpretation thereof by any Governmental Authority charged with the administration thereof or any other authority having jurisdiction over Lender or the Loans, whether or not having the force of law, shall impose, modify or deem applicable any reserve and/or special deposit requirement against or in respect of assets held by or deposits in or for the account of the Loans by Lender or impose on Lender any other condition with respect to this Agreement or the Loans, the result of which is to either increase the cost to Lender of making or maintaining the Loans or to reduce the amount of principal or interest received or receivable by Lender with respect to such Loans. Said additional costs and/or reductions will be those which directly result from the imposition of such requirement or condition on the making or maintaining of such Loans.

  • Policy Requirements All of the policies of insurance referred to in this Article XIII shall be written in form reasonably satisfactory to Landlord and any Facility Mortgagee and issued by insurance companies with a minimum policyholder rating of “A-” and a financial rating of “VII” in the most recent version of Best’s Key Rating Guide, or a minimum rating of “BBB” from Standard & Poor’s or equivalent. If Tenant obtains and maintains the general liability insurance described in Section 13.1(e) above on a “claims made” basis, Tenant shall provide continuous liability coverage for claims arising during the Term. In the event such “claims made” basis policy is canceled or not renewed for any reason whatsoever (or converted to an “occurrence” basis policy), Tenant shall either obtain (a) “tail” insurance coverage converting the policies to “occurrence” basis policies providing coverage for a period of at least three (3) years beyond the expiration of the Term, or (b) an extended reporting period of at least three (3) years beyond the expiration of the Term. Tenant shall pay all of the premiums therefor, and deliver certificates thereof to Landlord prior to their effective date (and with respect to any renewal policy, prior to the expiration of the existing policy), and in the event of the failure of Tenant either to effect such insurance in the names herein called for or to pay the premiums therefor, or to deliver such certificates thereof to Landlord, at the times required, Landlord shall be entitled, but shall have no obligation, to effect such insurance and pay the premiums therefor, in which event the cost thereof, together with interest thereon at the Overdue Rate, shall be repayable to Landlord upon demand therefor. Tenant shall obtain, to the extent available on commercially reasonable terms, the agreement of each insurer, by endorsement on the policy or policies issued by it, or by independent instrument furnished to Landlord, that it will give to Landlord thirty (30) days’ (or ten (10) days’ in the case of non-payment of premium) written notice before the policy or policies in question shall be altered, allowed to expire or cancelled. Notwithstanding any provision of this Article XIII to the contrary, Landlord acknowledges and agrees that the coverage required to be maintained by Tenant may be provided under one or more policies with various deductibles or self-insurance retentions by Tenant or its Affiliates, subject to Landlord’s approval not to be unreasonably withheld. Upon written request by Xxxxxxxx, Tenant shall provide Landlord copies of the property insurance policies when issued by the insurers providing such coverage.

  • Regulatory Agencies Nothing herein contained shall grant, or be construed to grant, PDC the right or authority to waive or release any rights, privileges, or obligations which Partnership may have federal or state laws or under rules, regulations or orders promulgated under such laws in reference to oil, gas and mineral operations, including the location, operation, or production of xxxxx, on tracts offsetting or adjacent to the Contract Area. With respect to operations hereunder, the Partnership agrees to release PDC from any and all losses, damages, injuries, claims and causes of action arising out of, incident to or resulting directly or indirectly from Operator's interpretation or application of rules, rulings, regulations, or orders of the Department of Energy or predecessor or successor agencies to the extent such interpretation or application was made in good faith. The Partnership further agrees to reimburse PDC for any amounts applicable to Partnerships share of production that PDC may be required to refund, rebate or pay as a result of such an incorrect interpretation or application.

  • Regulatory Requirements Each Party’s obligations under this Agreement shall be subject to its receipt of any required approval or certificate from one or more Governmental Authorities in the form and substance satisfactory to the applying Party, or the Party making any required filings with, or providing notice to, such Governmental Authorities, and the expiration of any time period associated therewith. Each Party shall in good faith seek and use its Reasonable Efforts to obtain such other approvals. Nothing in this Agreement shall require Developer to take any action that could result in its inability to obtain, or its loss of, status or exemption under the Federal Power Act or the Public Utility Holding Company Act of 2005 or the Public Utility Regulatory Policies Act of 1978, as amended.

  • Blue Sky Requirements The Company shall provide counsel to the Representative with ten copies of all proxy information and all related material filed with the Commission in connection with a Business Combination concurrently with such filing with the Commission. In addition, the Company shall furnish any other state in which its initial public offering was registered, such information as may be requested by such state.

  • E-Verify Requirements To the extent applicable under ARIZ. REV. STAT. § 41- 4401, the Contractor and its subcontractors warrant compliance with all federal immigration laws and regulations that relate to their employees and their compliance with the E-verify requirements under ARIZ. REV. STAT. § 23-214(A). Contractor’s or its subcontractor’s failure to comply with such warranty shall be deemed a material breach of this Agreement and may result in the termination of this Agreement by the City.

  • Safety Requirements 17.1.1 The Concessionaire shall comply with the provisions of this Agreement, Applicable Laws and Applicable Permits and conform to Good Industry Practice for securing the safety of the Users. In particular, the Concessionaire shall develop, implement and administer a surveillance and safety programme for providing a safe environment on or about the Project, and shall comply with the safety requirements.

  • Program Requirements A. The parties shall comply with the Disadvantaged Business Enterprise Program requirements established in 49 CFR Part 26.

  • Residency Requirements 1. All single first-year freshmen students are required to live in University housing for at least two academic semesters. All single students who have earned less than 30 credit hours and have not resided in University housing for two academic semesters are required to live on campus for two academic semesters. This policy does not apply to single first-year students who have been out of high school for more than one year, or to single first-year freshmen who live with their parents in Miami-Dade or Broward Counties. Neither does it apply to those students who, for disciplinary or administrative reasons, may be denied the privilege of continued residency on campus.

  • City Requirements Design, construction, materials, sizing, other specifications, permitting, inspections, testing, documentation and furnishing of as-built drawings, and acceptance of completed infrastructure shall be in accordance with City Requirements. Design and construction shall be by professionals licensed in the state of North Carolina to do the relevant work. City approval of the design of the Improvements shall be required prior to construction, as set forth in City Requirements. If Developer is connecting to the County sewer system, the City may require Developer to furnish the contract providing for such connection.

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