Lifestyle Considerations Sample Clauses

Lifestyle Considerations. Participants must be able and willing to adhere to the lifestyle restrictions detailed in Table 4. Food Participants will remain on a Cu/Mo controlled diet. Standardized Cu- and Mo-controlled meals will be provided as described in the SoA (Table 1). Male participants will receive larger meals than female participants, with adequate meal size to ensure appropriate daily caloric intake. If a participant is unable to eat 100% of the food, the remaining food will be weighed and reported in the CRF to support Cu/Mo determination as a fraction of the total meal. Participants will be expected to fast overnight. During the dosing period (Day 1 through Day 15), participants will be administered ALXN1840 with 240 mL of water each morning; participants must remain fasted for a least 2 hours after dose administration. Participants must allow for collection of all stool and urine from Day -4 through Day 30) Dietary restrictions will remain in place from Day -7 through Day 30 Participants may return to routine diet after completion of Day 30. Fluids All participants will drink water from the same large water bottle dispenser. There will be no set maximum volume of water that the participants must consume, but there will be a minimal volume that they must consume each day (1.5 L). The precise volume that each participant consumes will be measured. Water restrictions will remain in place from Day -7 through Day 30 Participants may return to routine fluid intake after completion of Day 30. Tobacco in any form (eg, smoking or chewing), other nicotine-containing products in any form (eg, gum, patch, electronic cigarettes), or any recreational inhalational product. From Screening to EOS visit. Restrictions ends after completion of EOS visit. Not consume any other substances known to be potent inhibitors or inducers of CYP450s. This includes food or drink products containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits). Red wine should also not be consumed. Within 7 days before check- in to the CRU (Day -8) until discharge on Day 31. After discharge from the CRU. Caffeine-containing or xanthine-containing products (eg, tea, coffee, cola drinks, and chocolate). During each dosing period, 24 hours before check-in to the CRU (Day -8) through Day 30. After collection of the final PK sample for the study (Day 30). Energy drinks or drinks containing taurine, glucuronolactone (...
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Related to Lifestyle Considerations

  • General Considerations a. All reports, drawings, designs, specifications, notebooks, computations, details, and calculation documents prepared by Vendor and presented to the Board pursuant to this Agreement are and remain the property of the Board as instruments of service. b. All analyses, data, documents, models, modeling, reports and tests performed or utilized by Vendor shall be made available to the Board upon request and shall be considered public records. c. Vendor is required to: (i) keep and maintain public records required by Board; (ii) upon request from Board’ s custodian of public records, provide Board with a copy of the requested records or allow the records to be inspected or copied within a reasonable time at a reasonable or as otherwise provided by law; (iii) ensure that public records that are exempt or, confidential and exempt, from public records disclosure requirements are not disclosed except as authorized by law for the duration of this Agreement and following completion of this Agreement if Vendor does not transfer the records to Board; (iv) upon completion of this Agreement, transfer, at no cost, to Board all public records in possession of Vendor or keep and maintain public records required by Board. d. If Vendor transfers all public records to Board upon completion of this Agreement, Vendor shall destroy any duplicate public records that are exempt or, confidential and exempt, from public records disclosure requirements. If Vendor keeps and maintains public records upon completion of this Agreement, Vendor shall meet all applicable requirements for retaining public records. All records stored electronically must be provided to Board, upon request from Board’s custodian of public records, in a format that is compatible with the information technology systems of Board. e. Vendor shall keep all books, records, files, drawings, plans and other documentation, including all electronically stored items, which concern or relate to the services required hereunder (the “Records”), for a minimum of five (5) years from the date of expiration or suspension of this Agreement, or as otherwise required by any applicable law, whichever date is later. The Board shall have the right to order, inspect, and copy all the Records as often as it deems necessary during any such period-of-time. The right to audit, inspect, and copy Records shall include all of the records of sub-Vendors (if any). f. Vendor shall, at all times, comply with the Florida Public Records Law, the Florida Open Meeting Law and all other applicable laws, rules and regulations of the State of Florida. g. IF THE VENDOR HAS QUESTIONS REGARDING THE APPLICATION OF CHAPTER 119, FLORIDA STATUTES, TO THE VENDORS’ DUTY TO PROVIDE PUBLIC RECORDS RELATING TO THIS AGREEMENT, CONTACT THE CUSTODIAN OF PUBLIC RECORDS AT 000-000-0000, Sumter County Board of County Commissioners, 0000 Xxxxxx Xxxx, Wildwood, Florida 34785 or via email at Xxxxxxx@xxxxxxxxxxxxxx.xxx. h. Vendor shall, at all times, carry General Liability, and Worker’s Compensation Insurance pursuant to the insurance requirements in RFP 000-0-0000/JV, naming Board as both a certificate holder and an additional insured in each such policy. i. Upon Vendor’s written request, the Board will furnish, or cause to be furnished, such reports, studies, instruments, documents, and other information as Vendor and Board mutually deem necessary, and Vendor may rely upon same in performing the services required under this Agreement. j. Vendor is obligated by this agreement to comply with Section 20.055(5), Florida Statutes. k. Any entity or affiliate who has had its Certificate of Qualification suspended, revoked, denied or have further been determined by the Department to be a non-responsive contractor may not submit a bid.

  • Special Considerations The Provider position may be abolished at any time by the Collin County Commissioners Court.

  • Other Considerations A. Changes to an Approved Scope of Work: The Recipient(s) shall notify FEMA and shall require a subrecipient to notify it immediately when a subrecipient proposes changes to an approved scope of work for an Undertaking. 1. If FEMA determines the change meets a Programmatic Allowance or has no effect on the property, FEMA shall approve the change. 2. If the change can be modified to meet a Programmatic Allowance, or conform to any applicable SOI Standards, FEMA shall conclude its Section 106 review responsibilities. 3. If FEMA determines that the change does not meet an Allowance, FEMA shall initiate consultation pursuant to Stipulation II.C, Standard Project Review. B. Unexpected Discoveries, Previously Unidentified Properties, or Unexpected Effects: 1. Upon notification by a subrecipient of an unexpected discovery, or if it appears that an Undertaking has affected a previously unidentified property or affected a known historic property in an unanticipated manner, in accordance with Stipulation I.B.3(e), Recipient(s) Roles and Responsibilities, the Recipient(s) shall immediately notify FEMA and require the subrecipient to: a. Stop construction activities in the vicinity of the discovery. b. Take all reasonable measures to avoid or minimize harm to the property until FEMA has completed consultation with the SHPO, participating Tribe(s), and any other consulting parties. Upon notification by the Recipient of a discovery, FEMA shall immediately notify the SHPO, participating Tribe(s), and other consulting parties that may have an interest in the discovery, previously unidentified property or unexpected effects, and consult to evaluate the discovery for National Register eligibility and/or the effects of the Undertaking on historic properties. c. If human remains are discovered, cease work at that location immediately and contact the Wisconsin Historical Society Burial Sites Preservation Program office at (000) 000-0000 for further instruction pursuant to Wis. Stat. § 157.70 and Wis. Admin. Code § HS 2. Discoveries of human remains on Federal or Tribal lands shall be subject to the Native American Xxxxxx Protection and Repatriation Act (NAGPRA) (25 U.S.C. §3001-3013, 18 U.S.C. § 1170) and ARPA, as applicable. d. Assist FEMA in completing the following actions, as required: i. FEMA shall consult with the SHPO, participating Tribe(s), and other consulting parties in accordance with the consultation process outlined in Stipulation II, Project Review, to develop a mutually agreeable action plan with timeframes to identify the discovery or previously unidentified property, take into account the effects of the Undertaking, resolve adverse effects if necessary, and ensure compliance with applicable Federal, State, and local statutes. ii. FEMA shall coordinate with the Recipient(s) and the subrecipient regarding any needed modification to the scope of work for the Undertaking necessary to implement recommendations of the consultation and facilitate proceeding with the Undertaking. iii. In cases where discovered human remains are determined to be Native American, FEMA shall consult with the appropriate Tribal representatives and SHPO, consistent with all provisions of Wis. Stat. § 157.70 and NAGPRA, if applicable. In addition, FEMA shall follow the guidelines outlined in the ACHP’s Policy Statement Regarding the Treatment of Burial Sites, Human Remains, and Funerary Objects (2007) and the Wisconsin Archeological Survey’s Guide for Public Archeology in Wisconsin.

  • Financial Considerations 5.1 In the event aggregate funding provided to SCDDO from county, state and/or federal sources is reduced or in any way becomes insufficient to fund this Agreement, the obligations of both SCDDO and the CSP must thereupon be: (1) reduced on a pro rata basis, or (2) renegotiated or terminated, provided that any termination of this Agreement must be without prejudice to any obligations or liabilities of the parties accrued prior to the termination. 5.2 Upon discovery thereof, the CSP, or its employees, subcontractors or authorized agents will report to SCDDO any suspected or identified abuse, fraud or waste related to funds as identified in this Agreement. For the CSP’s convenience, SCDDO provides access to “Our Workplace” to report such suspected abuse, fraud or waste. Our Workplace may be accessed via the internet at xxx.XxxXxxxxxxxx.xxx (ID SCDDO615), or via phone at (000) 000-0000. The CSP agrees to post printed information on Our Workplace in an area accessible by its employees. The CSP also agrees to ensure that its employees are educated on abuse, fraud and waste and have a means to report suspected incidents thereof. Training on abuse, fraud and waste is available through Relias.

  • FOR GOOD AND VALUABLE CONSIDERATION Borrower hereby forever relieves, releases, and discharges Bank and its present or former employees, officers, directors, agents, representatives, attorneys, and each of them, from any and all claims, debts, liabilities, demands, obligations, promises, acts, agreements, costs and expenses, actions and causes of action, of every type, kind, nature, description or character whatsoever, whether known or unknown, suspected or unsuspected, absolute or contingent, arising out of or in any manner whatsoever connected with or related to facts, circumstances, issues, controversies or claims existing or arising from the beginning of time through and including the date of execution of this Amendment (collectively “Released Claims”). Without limiting the foregoing, the Released Claims shall include any and all liabilities or claims arising out of or in any manner whatsoever connected with or related to the Loan Documents, the Recitals hereto, any instruments, agreements or documents executed in connection with any of the foregoing or the origination, negotiation, administration, servicing and/or enforcement of any of the foregoing.

  • Environmental Considerations A. Company, its officers, agents, servants, employees, invitees, independent contractors, successors, and assigns will not discharge or spill any Hazardous Substance, as defined herein, into any component of the storm drainage system or onto any paved or unpaved area within the boundaries of the Premises. In addition, Company will not discharge or spill any Hazardous Substance into any component of the sanitary sewer system without first neutralizing or treating same as required by applicable anti-pollution laws or ordinances, in a manner satisfactory to Authority and other public bodies, federal, state, or local, having jurisdiction over or responsibility for the prevention of pollution of canals, streams, rivers, and other bodies of water. Company’s discharge, spill or introduction of any Hazardous Substance onto the Premises or into any component of Authority’s sanitary or storm drainage systems will, if not remedied by Company with all due dispatch, at the sole discretion of Authority, be deemed a default and cause for termination of this Agreement by Authority, subject to notice and cure. Such termination will not relieve Company of or from liability for such discharge or spill. B. If Company is deemed to be a generator of hazardous waste, as defined by federal, state, or local law, Company will obtain a generator identification number from the U. S. Environmental Protection Agency (EPA) and the appropriate generator permit and will comply with all federal, state, and local laws, and any rules and regulations promulgated thereunder, including but not limited to, ensuring that the transportation, storage, handling, and disposal of such hazardous wastes are conducted in full compliance with applicable law. C. Company agrees to provide Authority, within 10 days after Authority’s request, copies of all hazardous waste permit application documentation, permits, monitoring reports, transportation, responses, storage and disposal plans, material safety data sheets and waste disposal manifests prepared or issued in connection with Company’s use of the Premises. D. At the end of the Agreement, Company will dispose of all solid and hazardous wastes and containers in compliance with all applicable regulations. Copies of all waste manifests will be provided to Authority at least 30 days prior to the end of the Agreement.

  • The Consideration 9.1. In consideration for the successful completion of the Works, the timely supply of the R350HT Rails and the fulfillment of all of Supplier's obligations pursuant to this Agreement including, without limitation, the Warranty and all accompanying services and equipment to ISR's full satisfaction as required in accordance with the terms and conditions of this Agreement, Supplier shall be entitled to receive payment in accordance with the Consideration Annex attached hereto as Annex B (the “Consideration”). 9.2. Consideration shall be the final, complete and inclusive price that shall be paid to Supplier for the design, manufacture, preservation treatment, supply, delivery, unloading and Warranty of the R350HT Rails and the execution of all the Works pursuant to this Agreement, exclusive only of VAT. Other than as set forth herein, the Supplier shall not be entitled to receive any additional payments in connection with the performance of its obligations hereunder. The Consideration is inclusive of all taxes (other than VAT), license fees, royalties, or any other costs or expenses of any kind related to the provision of the R350HT Rails and/or to the Works. ISR shall not be charged with any further payments in connection with the Supplier’s execution of any of its obligations and undertakings under this Agreement. 9.3. Value added tax, to the extent applicable, shall be added to any payment made by ISR to Supplier hereunder, subject to the issuance of a tax invoice on ISR’s name, in accordance with the law. All amounts payable to the Supplier under this Agreement shall be paid in Euros (€). 9.4. For the removal of any doubt, it is hereby clarified that all taxes, fees, duties, licenses, costs or other payments that are to be paid in connection with the exportation, supply and delivery of the R350HT Rails, including but not limited to all types of importation and custom duties and services, such as transportation costs, customs agents’ fees, purchase tax (in Hebrew "Mas Kniya" or "הינק סמ" ), wharf fees (in Hebrew "Dmei Ratzif" or "ףיצר ימד" ), cleaning of the containers and unloading at the Site, Israeli customs duties, port handling fees (in Hebrew "Dmei Xxxxx" or "לוטינ ימד" ), port infrastructure fees (in Hebrew "Dmei Tashtit" or "תיתשת ימד"), cam locks for discharging the R350HT Rails at port, supervision while discharging at port, discharging terms at port, etc. shall be considered as part of the Consideration and shall be borne solely by Supplier.

  • Tax Considerations Notwithstanding anything herein to the contrary, in the event any payments or benefits provided to the Executive hereunder upon a Change in Control are determined by the Company to be subject to the tax imposed by Section 4999 of the Internal Revenue Code (the "Code", with all Code Section references used herein being deemed to include any regulations thereunder), or any similar federal or state excise tax, FICA tax, or any interest or penalties are incurred by the Executive with respect to such excise tax (such excise tax, together with any such interest and penalties are hereinafter collectively referred to as the "Excise Tax"), the Company shall pay to the Executive at the time specified in Section 5.5 (b) or 5.7 above (whichever applies), an additional amount (the "Gross-Up Payment") such that after the payment by the Executive of all federal, state, or local income taxes, Excise Taxes, FICA tax, or other taxes (including any interest or penalties imposed with respect thereto) imposed upon the receipt of the Gross-Up Payment, Executive retains an amount of the Gross-Up Payment equal to the Excise Tax imposed on the severance payments and benefits provided herein. (a) For purposes of determining whether any payments or benefits to the Executive hereunder will be subject to the Excise Tax and the amount of such Excise Tax: (i) all payments or benefits received or to be received by the Executive in connection with a Change in Control or the termination of employment (whether pursuant to the terms of this Agreement or of any other plan, arrangement or agreement with the Company) shall be treated as "parachute payments" within the meaning of Section 280G(b)(2) of the Code, and all "excess parachute payments" within the meaning of Section 280G(b)(1) shall be treated as subject to the Excise Tax, unless in the opinion of tax counsel selected by the Company and acceptable to the Executive, such payments or benefits (in whole or in part) do not constitute parachute payments under Section 280G of the Code, or such excess parachute payments (in whole or in part) represent reasonable compensation for services actually rendered within the meaning of Section 280G(b)(4) of the Code; (ii) the amount of the severance payments which shall be treated as subject to the Excise Tax shall be equal to the amount of excess parachute payments within the meaning of Sections 280G(b)(1) and (4) (after applying clause (a), above); and (iii) the parachute value of any noncash benefits or any deferred payment or benefit shall be determined by Company in accordance with the principles of Sections 280G(d)(3) and (4) of the Code. (b) If the Excise Tax is subsequently determined to be less than the amount taken into account hereunder at the time of termination of employment, the Executive shall repay to the Company, at the time the reduction in Excise Tax is finally determined, the portion of the Gross-Up Payment attributable to such reduction. If the Excise Tax is determined to exceed the amount taken into account hereunder at the time of termination of employment, the Company shall make an additional Gross-Up Payment to the Executive in respect of such excess at the time the amount of such excess is finally determined. The Executive shall notify the Company in writing of any claim by the Internal Revenue Service that, if successful, would require the payment by the Company of the Gross-Up Payment. Such notification shall be given as soon as practicable but no later that ten business days after the Executive is informed in writing of such claim and shall apprise the Company of the nature of such claim and the date on which such claim is requested to be paid. The Executive shall not pay such claim prior to the expiration of the 30 calendar day period following the date on which it gives such notice to the Company (or such shorter period ending on the date that any payment of taxes with respect to such claim is due). If the Company notifies the Executive in writing prior to the expiration of such period that it desires to contest such claim, the Executive shall: (i) give the Company any information reasonably requested by the Company relating to such claim, (ii) take such action in connection with contesting such claim as the Company shall reasonably request in writing from time to time, including, without limitation, accepting legal representation with respect to such claim by an attorney reasonably selected by the Company, (iii) cooperate with the Company in good faith in order to effectively contest such claim, and (iv) permit the Company to participate in any proceedings relating to such claim; provided, however, that the Company shall bear and pay directly all costs and expenses (including legal and accounting fees and additional interest and penalties) incurred in connection with such contest and shall indemnify and hold the Executive harmless, on an after-tax basis, for any Excise Tax, FICA tax or income tax (including interest and penalties with respect thereto) imposed as a result of such representation and payment of costs and expenses. Without limitation on the foregoing provisions of this section, the Company shall control all proceedings taken in connection with such contest and, at its sole option, may pursue or forgo any and all administrative appeals, proceedings, hearings and conferences with the taxing authority in respect of such claim and may, at its sole option, either direct the Executive to pay the tax claimed and xxx for a refund or contest the claim in any permissible manner, and the Executive agrees to prosecute such contest to a determination before any administrative tribunal, in a court of initial jurisdiction and in one or more appellate courts, as the Company shall determine; provided, however, that if the Company directs the Executive to pay such claim and xxx for a refund, the Company shall advance the amount of such payment to the Executive, on an interest-free basis, and shall indemnify and hold the Executive harmless, on an after-tax basis, from any Excise Tax or income tax (including interest or penalties with respect thereto) imposed with respect to such advance or with respect to any imputed income with respect to such advance; and further provided that any extension of the statute of limitations relating to payment of taxes for the taxable year of the Executive with respect to which such contested amount is claimed to be due is limited solely to such contested amount. Furthermore, the Company's control of the contest shall be limited to issues with respect to which a Gross-Up Payment would be payable hereunder and the Executive shall be entitled to settle or contest, as the case may be, any other issue raised by the Internal Revenue Service or any other taxing authority. If any such claim referred to in this Section is made by the Internal Revenue Service and the Company does not request the Executive to contest the claim within the 30 calendar day period following notice of the claim, the Company shall pay to the Executive the amount of any Gross-Up Payment owed to the Executive, but not previously paid pursuant to Section 7.1(b), immediately upon the expiration of such 30 calendar day period. If any such claim is made by the Internal Revenue Service and the Company requests the Executive to contest such claim, but does not advance the amount of such claim to the Executive for purposes of such contest, the Company shall pay to the Executive the amount of any Gross-Up Payment owed to the Executive, but not previously paid under the provisions of Section 7.1(b), within 5 business days of a Final Determination of the liability of the Executive for such Excise Tax. For purposes of this Agreement, a "Final Determination" shall be deemed to occur with respect to a claim when (i) there is a decision, judgment, decree or other order by any court of competent jurisdiction, which decision, judgment, decree or other order has become final, i.e., all allowable appeals pursuant to this section have been exhausted by either party to the action, (ii) there is a closing agreement made under Section 7121 of the Code, or (iii) the time for instituting a claim for refund has expired, or if a claim was filed, the time for instituting suit with respect thereto has expired. If, after the receipt by the Executive of an amount advanced by the Company pursuant to this section, the Executive becomes entitled to receive any refund with respect to such claim, the Executive shall (subject to the Company's complying with the requirements of this Section) promptly pay to the Company the amount of such refund (together with any interest paid or credited thereon after taxes applicable thereto). If, after the receipt by the Executive of an amount advanced by the Company pursuant to this Section, a determination is made by the Internal Revenue Service that the Executive is not entitled to any refund with respect to such claim and the Company does not notify the Executive in writing of its intent to contest such denial of refund prior to the expiration of 30 calendar days after such determination, then such advance shall be forgiven and shall not be required to be repaid and the amount of such advance shall offset, to the extent thereof, the amount of Gross-Up Payment required to be paid.

  • Share Consideration Nation Energy Inc., a Wyoming corporation, has agreed to issue on December 17, 2015 600,000,000 of its common shares (the Share Consideration) to Paltar, and Paltar has agreed to certain restrictions on the transfer of such shares, under the terms of the Third Amended and Restated Letter Agreement, dated 30 August 2015 between Nation Energy Inc. and Paltar (the Letter Agreement), in the event that an Exchange Transaction (as defined in the Letter Agreement) has not been consummated on or before December 16, 2015.

  • Settlement Consideration In consideration of the full settlement, satisfaction, compromise and release of the Released Plaintiffs’ Claims, an aggregate $115 million in cash (the “Escrow Amount”) shall be paid on behalf of the Settling Defendants to Freeport by the D&O Carriers. The Settling Defendants shall cause the Escrow Amount to be deposited by the D&O Carriers into an interest-bearing escrow account controlled by an agreed upon representative of Plaintiffs and of the Settling Defendants (the “Escrow Account”) within fifteen (15) business days after the Stipulation is submitted to the Court. Upon the Effective Date, the Escrow Amount, together with any and all interest thereon, shall be paid to Freeport from the Escrow Account. For the avoidance of doubt, the Settling Defendants shall have no obligation to deposit any portion of the Escrow Amount into the Escrow Account but shall have an obligation to take all reasonably available steps to seek to cause the D&O Carriers to deposit the Escrow Amount into the Escrow Account.

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