Tamper-evident means a one-time-use security tape or seal that is affixed to the opening of a package, allowing a person to recognize whether the package has been opened.
Deciding Official means the person chosen by the protestor to decide the agency protest; it may be either the Contracting Officer or the Agency Protest Official.
Institutional Signing Official The label, "Signing Official," is used in conjunction with the NIH eRA Commons and refers to the individual that has institutional authority to legally bind the institution in grants administration matters. The individual fulfilling this role may have any number of titles in the institution, but is typically located in its Office of Sponsored Research or equivalent. The Signing Official for the Requester reviews Data Access Request, Project Renewal, and Project Close-out applications submitted by Principal Investigators and legally binds the Requester to agree to adhere to the terms described in this Agreement if the application is submitted to NIH. The Institutional Signing Official for the Submitting Institution enters into the Institutional Certification and signs on behalf of the Submitting Investigator(s) who has submitted data. Principal Investigator (PI): The investigator who prepares Data Access Requests (DARs), Project Renewals, and Project close-outs. The Principal Investigator plays a lead role in ensuring that management and use of controlled-access data remains consistent with the terms in the Data Use Certification Agreement. To be able to submit a DAR, a Principal Investigator must be designated as such by their institution in eRA Commons and be a permanent employee of their institution at a level equivalent to a tenure-track professor or senior scientist with responsibilities that most likely include laboratory administration and oversight.
Building Official means that person, or designee, certified by the State and designated as such to administer the State Building Codes for the City.
Protocol Number 1002-048 Protocol Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C Protocol Date: 18 January 2017 Sponsor: Esperion Therapeutics, Inc. Country where Institution is Conducting Study Czech Republic Location where the study will be conducted: Kardiologická ambulance, which is a division/part of the Institution Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) ECMT / EC / RA ECMT: Ethics Committee Fakultni nemocnice v Motole V Uvalu 84 150 06 Xxxxx 0 Xxxxx Xxxxxxxx; Mgr. xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod RA: State Institute for Drug Control, Xxxxxxxxx 00, 000 00 Xxxxx 00 Xxxxx Xxxxxxxx Investigator name, (the “Investigator”) xxxxxxxxxxxxx Číslo Protokolu: 1002-048 Název Protokolu: Randomizované, dvojitě zaslepené, placebem kontrolované multicentrické klinické hodnocení, s paralelními skupinami, posuzující účinnost a bezpečnost kyseliny bempedové (ETC 1002) 180 mg denně jako doplňku k léčbě ezetimibem u pacientů se zvýšenou hladinou LDL-C Datum Protokolu: 18. 1. 2017 Zadavatel: Esperion Therapeutics, Inc. Stát, ve kterém má sídlo Zdravotnické zařízení, které provádí Studii Česká republika Místo, kde bude prováděna Studie: Kardiologická ambulance, která je součástí/oddělením Zdravotnického zařízení Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) MEK / EK / SÚKL MEK: Etická komise Fakultní nemocnice v Motole V Úvalu 84 150 06 Xxxxx 0 Xxxxx xxxxxxxxx; xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00 Xxxxx xxxxxxxxx Jméno zkoušejícího, ( “Zkoušející”) xxxxxxxxxxxxx The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice:
dangerous in relation to any fence means:
Lot or batch number means an identifying number assigned by the enterprise to a designated group of items, usually referred to as either a lot or a batch, all of which were manufactured under identical conditions.
Substantially Complete or “Substantial Completion” shall mean that (a) the Base Building Improvements that are required to permit Tenant to enter the Premises for purposes of performing the Tenant Improvement have been completed in accordance with the Building Plans, the correction or completion of which items, collectively, will not substantially interfere with Tenant’s ability to commence the Tenant Improvement Work and (b) Tenant is legally permitted to enter the Premises for purposes of performing the Tenant Improvement Work. Landlord and Tenant shall then arrange a mutually convenient time, no later than ten (10) Business Days after the anticipated Substantial Completion Date specified in Landlord’s notice, for Tenant and/or Tenant’s Architect (as defined below) and Landlord and/or Landlord’s Architect to conduct a walk-through inspection of the Base Building Improvements. During the inspection, Landlord’s Architect shall compile a punchlist of items yet to be completed. If Tenant or Tenant’s Architect shall fail to inspect the Base Building Improvements within ten (10) Business Days after the Substantial Completion Date specified in Landlord’s notice, the Base Building Improvements shall be deemed completed and satisfactory in all respects, and the Substantial Completion Date shall be the date set forth in Landlord’s notice. Landlord shall use commercially reasonable efforts to cause the remaining Base Building Improvements to have been completed on or before the Term Commencement Date in accordance with the Building Plans, the correction or completion of which items, collectively, will not substantially interfere with Tenant’s ability to occupy the Premises to commence the Tenant Improvement Work
receiving officer ’ means, in relation to—
The Inspecting Officer means the person specified in the contract for the purpose of Inspection of stores or work under the contract and includes his authorised representative;
Contractor Commercially Sensitive Information means the information listed in the Contractor Commercial Sensitive Information Annex to the Contract being information notified by the Contractor to the Authority which is acknowledged by the Authority as being commercially sensitive information.
Returning Officer means a Returning Officer appointed pursuant to the Act;
Ordering Officer means any person within the Agency authorised to order particular Services under the Contract.
danger means any hazard or condition that could reasonably be expected to cause injury or illness to an employee or other persons exposed thereto before the hazard or condition can be corrected.
Environmentally Sensitive Material means oil, oil products and any other substance (including any chemical, gas or other hazardous or noxious substance) which is (or is capable of being or becoming) polluting, toxic or hazardous;
Certified inspector means an employee or agent of a VESCP authority who (i) holds a certificate of competence from the Board in the area of project inspection or (ii) is enrolled in the Board's training program for project inspection and successfully completes such program within one year after enrollment.
Reviewing official means the individual who shall make the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the Category 1 or Category 2 quantities of radioactive materials that are possessed by the licensee.
Impulsive sound means either a single pressure peak or a single burst (multiple pressure peaks) that has a duration of less than one second.
Dangerous weapon means any weapon, device, instrument, material, or substance, animate or inanimate, which under the circumstances in which it is used, attempted to be used, or threatened to be used is readily capable of causing death or serious physical injury.
Recording officer means the county clerk of the county of Cort-
Substantially Completed shall have the meanings set forth for such terms in the Work Letter. If Tenant does not elect to void this Lease within 10 business days of the lapse of such 270 day period, such right to void this Lease shall be waived and this Lease shall remain in full force and effect; provided that Tenant will have a second right to terminate this Lease in the event Landlord has still not Delivered the Premises within 365 days of the Target Commencement Date for any reason other than Force Majeure delays and Tenant Delays, which right will be exercisable for a period of 10 business days after such 365 day period. The “Commencement Date” shall be the earlier of: (i) the date Landlord Delivers the Premises to Tenant; or (ii) the date Landlord could have Delivered the Premises but for Tenant Delays. Notwithstanding anything to the contrary contained in this Lease, but provided Tenant is not in Default hereunder, Landlord hereby grants Tenant an abatement of the Base Rent payable during the period beginning on the Commencement Date and ending 10 months after the Commencement Date (“Base Rent Abatement”). Subject to the terms of Section 3(a) below, the first day of the 11th month after the Commencement Date shall be the “Rent Commencement Date.” In the event Landlord Delivers the Premises to Tenant more than 180 days after the Target Commencement Date (as extended for Force Majeure delays and Tenant Delays), the period of Base Rent Abatement and the Rent Commencement Date (and all subsequent rent increase dates) will be extended by an equivalent number of days that Delivery is delayed beyond the Target Commencement Date. Upon request of Landlord, Tenant shall execute and deliver a written acknowledgment of the Commencement Date, the Rent Commencement Date and the expiration date of the Term when such are established in the form of the “Acknowledgement of Commencement Date” attached to this Lease as Exhibit D; provided, however, Tenant’s failure to execute and deliver such acknowledgment shall not affect Landlord’s rights hereunder. The “Term” of this Lease shall be the Base Term, as defined above on the first page of this Lease and any Extension Terms which Tenant may elect pursuant to Section 39 hereof. Except as set forth in the Work Letter or otherwise expressly set forth in this Lease: (i) Tenant shall accept the Premises in their condition as of the Commencement Date with all Landlord’s Work Substantially Complete; (ii) Landlord shall have no liability for any defects in the Premises, except as set forth herein or in the Work Letter; and (iii) Tenant’s taking possession of the Premises shall be conclusive evidence that Tenant accepts the Premises and that the Premises were in good condition at the time possession was taken. Tenant will not be permitted occupancy of the Premises prior to the date upon which the Premises are Delivered to Tenant with Landlord’s Work Substantially Completed. Except as otherwise expressly set forth in this Lease (including the Work Letter), Tenant agrees and acknowledges that neither Landlord nor any agent of Landlord has made any representation or warranty with respect to the condition of all or any portion of the Premises or the Project, and/or the suitability of the Premises or the Project for the conduct of Tenant’s business, and Tenant waives any implied warranty that the Premises or the Project are suitable for the Permitted Use. This Lease (including all exhibits attached hereto and any side letters entered into by and between Landlord and Tenant in connection with this Lease) constitutes the complete agreement of Landlord and Tenant with respect to the subject matter hereof and supersedes any and all prior representations, inducements, promises, agreements, understandings and negotiations which are not contained herein.
Assistant Hydrographic Surveyor means the Assistant Hydrographic Surveyor of the Authority, as the case may be
Batch number means a unique numeric or alphanumeric identifier assigned prior to any testing to allow for inventory tracking and traceability.
Variation Form means the form that will be completed and signed by the Parties to effect a Variation which shall be in the form set out in Framework Schedule 19 (Variation Form);
Certifying Officer has the meaning set forth in Section 5.01(c).
Environmentally sensitive area means any area in which plant or animal life or their habitats are either rare or especially valuable because of their special nature or role in an ecosystem and which could be easily disturbed or degraded by human activities and developments.