Serialization within the part, lot, or batch number means each item of a particular part, lot, or batch number is assigned a unique serial number within that part, lot, or batch number assignment. The enterprise is responsible for ensuring unique serialization within the part, lot, or batch number within the enterprise identifier.
Serial number within the enterprise identifier means a combination of numbers, letters, or symbols assigned by the enterprise to an item that provides for the differentiation of that item from any other like and unlike item and is never used again within the enterprise.
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.
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:
Identifying number means a symbol or address that identifies only one unit in a common interest community.
Serialization within the enterprise identifier means each item produced is assigned a serial number that is unique among all the tangible items produced by the enterprise and is never used again. The enterprise is responsible for ensuring unique serialization within the enterprise identifier.
Registrant Fax Ext 4321 Registrant Email: XXXXX@XXXXXXX.XXX Admin ID: 5372809-ERL Admin Name: EXAMPLE REGISTRANT ADMINISTRATIVE Admin Organization: EXAMPLE REGISTRANT ORGANIZATION Admin Street: 000 XXXXXXX XXXXXX Xxxxx Xxxx: ANYTOWN Admin State/Province: AP Admin Postal Code: A1A1A1 Admin Country: EX Admin Phone: +1.0000000000 Admin Phone Ext: 1234 Admin Fax: +1.5555551213 Admin Fax Ext: Admin Email: XXXXX@XXXXXXX.XXX Tech ID: 5372811-ERL Tech Name: EXAMPLE REGISTRAR TECHNICAL Tech Organization: EXAMPLE REGISTRAR LLC Tech Street: 000 XXXXXXX XXXXXX Xxxx Xxxx: ANYTOWN Tech State/Province: AP Tech Postal Code: A1A1A1 Tech Country: EX Tech Phone: +1.1235551234 Tech Phone Ext: 1234 Tech Fax: +1.5555551213 Tech Fax Ext: 93 Tech Email: XXXXX@XXXXXXX.XXX Name Server: NS01.EXAMPLEREGISTRAR.TLD Name Server: NS02.EXAMPLEREGISTRAR.TLD DNSSEC: signedDelegation DNSSEC: unsigned >>> Last update of WHOIS database: 2009-05-29T20:15:00Z <<< Registrar Data: Query format: whois “registrar Example Registrar, Inc.” Response format: Registrar Name: Example Registrar, Inc. Street: 0000 Xxxxxxxxx Xxx City: Marina del Rey State/Province: CA Postal Code: 90292 Country: US Phone Number: +1.0000000000 Fax Number: +1.3105551213 Email: xxxxxxxxx@xxxxxxx.xxx WHOIS Server: whois.example-registrar.tld Referral URL: xxxx://xxx.xxxxxxx-xxxxxxxxx.xxx Admin Contact: Xxx Registrar Phone Number: +1.3105551213 Fax Number: +1.3105551213 Email: xxxxxxxxxxxx@xxxxxxx-xxxxxxxxx.xxx Admin Contact: Xxxx Registrar Phone Number: +1.3105551214 Fax Number: +1.3105551213 Email: xxxxxxxxxxxxx@xxxxxxx-xxxxxxxxx.xxx Technical Contact: Xxxx Geek Phone Number: +1.3105551215 Fax Number: +1.3105551216 Email: xxxxxxxx@xxxxxxx-xxxxxxxxx.xxx >>> Last update of WHOIS database: 2009-05-29T20:15:00Z <<< Nameserver Data: Query format: whois “NS1.EXAMPLE.TLD”, whois “nameserver (nameserver name)”, or whois “nameserver (IP Address)” Response format: Server Name: NS1.EXAMPLE.TLD IP Address: 192.0.2.123 IP Address: 2001:0DB8::1 Registrar: Example Registrar, Inc. WHOIS Server: whois.example-registrar.tld Referral URL: xxxx://xxx.xxxxxxx-xxxxxxxxx.xxx >>> Last update of WHOIS database: 2009-05-29T20:15:00Z <<< The format of the following data fields: domain status, individual and organizational names, xxxxxxx, xxxxxx, xxxx, xxxxx/xxxxxxxx, postal code, country, telephone and fax numbers (the extension will be provided as a separate field as shown above), email addresses, date and times should conform to the mappings specified in EPP RFCs 5730-5734 so that the display of this information (or values return in WHOIS responses) can be uniformly processed and understood. In order to be compatible with ICANN’s common interface for WHOIS (InterNIC), WHOIS output shall be in the format outline above.