Step therapy protocol means a protocol or program that establishes the specific
Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;
Kyoto Protocol means the protocol to the UNFCCC adopted at the Third Conference of the Parties to the UNFCCC in Kyoto, Japan on 11 December 1997 as may be amended;
Closing Press Release has the meaning set forth in Section 5.4(b).
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:
Adopted Protocol means the method(s) for the Interchange of Messages between the respective Parties and an intermediary appointed pursuant to Clause 8 for the presentation and structuring of the transmission of Messages as defined in Annex A;
Aircraft Protocol means the official English language text of the Protocol to the Convention on International Interests in Mobile Equipment on Matters Specific to Aircraft Equipment, adopted on November 16, 2001, at a diplomatic conference in Cape Town, South Africa, and all amendments, supplements, and revisions thereto (and from and after the effective date of the Cape Town Treaty in the relevant country, means when referring to the Aircraft Protocol with respect to that country, the Aircraft Protocol as in effect in such country, unless otherwise indicated).
Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.
service delivery and budget implementation plan means a detailed plan approved by the executive mayor of a municipality in terms of section 53(l)(c)(ii) of the MFMA for implementing the municipality's delivery of municipal services and its annual budget, and which must indicate
Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.2.
Common Language Location Identifier (CLLI means the codes that provide a unique eleven (11) character representation of a network interconnection point. The first eight (8) characters identify the city, state and building location, while the last three (3) characters identify the network component.
Distribution Protocol means the plan for distributing the Settlement Amount and accrued interest, in whole or in part, as approved by the Courts.
Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.
Donor profile record means all records about donors or potential donors to a public institution of higher education except the names and reported addresses of the actual donors and the date, amount, and conditions of the actual donation.
Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.
ERCOT Protocols means the document adopted by ERCOT, including any attachments or exhibits referenced in that document, as amended from time to time, that contains the scheduling, operating, planning, reliability, and Settlement (including Customer registration) policies, rules, guidelines, procedures, standards, and criteria of ERCOT. For the purposes of determining responsibilities and rights at a given time, the ERCOT Protocols, as amended in accordance with the change procedure(s) described in the ERCOT Protocols, in effect at the time of the performance or non-performance of an action, shall govern with respect to that action.
Electronic Product Code™ (EPC) means an identification scheme for universally identifying physical objects via RFID tags and other means. The standardized EPC data consists of an EPC (or EPC identifier) that uniquely identifies an individual object, as well as an optional filter value when judged to be necessary to enable effective and efficient reading of the EPC tags. In addition to this standardized data, certain classes of EPC tags will allow user-defined data. The EPC Tag Data Standards will define the length and position of this data, without defining its content.
Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.
Interconnection Activation Date means the date that the construction of the joint facility Interconnection arrangement has been completed, trunk groups have been established, joint trunk testing is completed and trunks have been mutually accepted by the Parties.
Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.
low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and
template version has the meaning ascribed to such term in NI 41-101 and includes any revised template version of marketing materials as contemplated by NI 41-101;
U.S. Special Resolution Regimes has the meaning specified in Section 11.21.
Internet Protocol or “IP” means a communications protocol for devices connected to the Internet that specifies the format for addresses and units of transmitted data.
New Services Queue Closing Date means each April 30 and October 31 shall be the Queue Closing Date for the New Services Queue comprised of Interconnection Requests, Completed Applications, and Upgrade Requests received during the six-month period ending on such date. New York ISO or NYISO: “New York ISO” or “NYISO” shall mean the New York Independent System Operator, Inc. or any successor thereto.
Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.