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Page 16 of 16 <br /> <br />is interfered with and which, by the exercise of reasonable diligence, said Party is unable to prevent; <br />the Party so suffering may, at its option, suspend, without liability, the performance of its <br />obligations hereunder during the period such cause continues. <br /> <br />11.7 MATERIAL CHANGES IN SCOPE OR CIRCUMSTANCES, OR EMERGENCY <br />CIRCUMSTANCES. If at any time during the Term of this Agreement, the City requests a <br />change in the scope, volume, quality/degree or quantum of services to be provided by Contractor, <br />or the scope of services set out herein must materially be changed as a result of any of the <br />following, any of which would result in an increase to the cost of providing the services or which <br />Contractor notifies the City affects CFMG’s ability to provide the requested scope of services <br />under the circumstances, (a “Material Change Circumstance”), including, but not limited to any <br />of the following: <br /> <br />• There is or are new, amended, and/or repealed law(s) or regulation(s) (including statutes, <br /> codes, Agency orders/memoranda and/or case law), or changes to the Client’s policies, <br /> procedures, practices, or circumstances, any or all of which render performance under the <br /> Agreement partially or completely impracticable or impossible under the Agreement’s <br /> existing terms; <br /> <br />• The United States Food and Drug Administration (“FDA”) or another regulatory body <br /> approves (or issues an emergency use authorization for) a new therapy/ies or treatment <br /> modality/ies, there are changes to legal/regulatory requirements concerning the treatment <br /> of Client’s patients, and/or changes to the applicable standard of care that materially <br /> impact the Contractor’s ability to provide services and/or costs under the Agreement; <br /> <br />• Contractor’s performance hereunder is impacted by any event related to a Public Health <br /> Emergency (PHE) declared pursuant to Section 319 of the Public Health Service Act, a <br /> Disaster declaration pursuant to the Stafford Act (2 U.S.C. §§ 5121-5207), or any similar <br /> announcement or proclamation made by the Federal Government or any Federal Agency, <br /> any Federally recognized Native American Tribe, or any State, County/Parish or Local <br /> Government pursuant to an analogous provision of Federal or non-Federal law or rule <br /> (each, an “Emergency Circumstance”). <br /> <br />the parties shall follow the procedures outlined in Subsection 11.7.1 below: <br /> <br />11.7.1 In the event of any Material Change Circumstance, upon notice from a Party, the Parties shall <br />meet and in good faith re-negotiate the terms of this Agreement. Material changes agreed upon by <br />the parties are subject to approval by the City Council for the City of Santa Ana. Changes which <br />do not increase the overall compensation to this Agreement may be approved by the City Manager <br />and the City Attorney. Neither Party shall unreasonably delay or withhold consent to such <br />negotiations, or the proposed modifications resulting from such negotiations. In the event the <br />Parties are not able to reach mutually acceptable changes to the Agreement after thirty (30) days, <br />either Party may thereafter terminate the Agreement without cause upon providing ninety 90 days’ <br />notice thereafter. <br /> <br /> 11.8 PERFORMANCE MEASURES. The City may assess penalties in the following amounts <br /> related to CFMG’s failure to meet the standards listed below. CFMG and City agree that such <br /> penalties may be provided as invoice credits by Contractor upon the mutual agreement of the <br /> parties in writing. <br /> <br />DocuSign Envelope ID: 6225CE08-C2AA-4269-9AF5-9311FF666B41