Data Lock Point definition

Data Lock Point means for a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in a PSUR.
Sample 1

Examples of Data Lock Point in a sentence

  • The Authority will accept a single harmonized IBD and Data Lock Point (DLP) for each product in order to reduce the burden of work in preparing PSURs/PBRERs for different regulatory authorities.In situations where an MAH is preparing PSURs/PBRERs on annual basis or longer period for different regulatory authorities based on the IBD and the Authority requires a six-month cycle based on the LBD, the most recent PSUR/PBRER with a longer time frame will be acceptable to the Authority.

  • Generally, each PSUR and PBRER should cover the period of time since the last PSUR/PBRER and should be submitted within 60 days after the Data Lock Point.

  • Remote SDV should at this point only be required for a few clinical trials: • Clinical trials investigating treatment and prevention of COVID-19• Pivotal clinical trials soon reaching Data Lock Point and thereby trial com- pletion, analysis and reporting of trial data.Implementation of remote access must be carried out in close collaboration with the site investigators.

  • In the event of a Shelf Registration, the Company shall bear or reimburse the Holders of the Securities covered thereby for an amount not to exceed $25,000 for the reasonable fees and disbursements of one firm of counsel designated by the Holders of a majority in principal amount of the Initial Securities and the Accredited Investor Securities covered thereby to act as counsel for the Holders of the Initial Securities and the Accredited Investor Securities in connection therewith.

  • CMS shall request the PSUR from NORGINE at least SEVENTY (70) Days in advance of the Data Lock Point (“DLP”).

  • For purposes of identifying patterns of use outside the terms of the reference product information, the MAH should use the appropriate sections (e.g., approved indication[s], contraindication[s]) of the reference product information that was in effect at the Data Lock Point (DLP) of the PBRER.

  • The Data Lock Point for DSUR will be the last day of the one-year reporting period (the 5th day of December).

  • As Fernbank Road is characterised by a mix of housing types, the proposed scale of development would not appear out of keeping in the street scene.

  • This is in order to determine the Data Lock Point (DLP) which is the date designated as the cut-off date for data to be included in a PBRER (9).

  • The same report should be submitted to all Member States where the company holds a marketing authorisation for a medicinal product with the same active substance within 60 days of the harmonised Data Lock Point (DLP).

Related to Data Lock Point

  • Data Log means a complete record of all Data Interchanged representing the Messages and their Associated Data between the parties;

  • Data Site means an electronic password protected data site maintained by the Borrower (or by the Collateral Manager on behalf of Borrower) at Xxxxxxx Corporation, Intralinks, SyndTrak Online or any other similar electronic distribution system reasonably acceptable to the Administrative Agent.

  • Data Processing Lease means any lease or licensing agreement, binding on the Failed Bank as of Bank Closing, the subject of which is data processing equipment or computer hardware or software used in connection with data processing activities. A lease or licensing agreement for computer software used in connection with data processing activities shall constitute a Data Processing Lease regardless of whether such lease or licensing agreement also covers data processing equipment.

  • Data Processing Addendum means Sprinklr’s Data Processing Addendum, located at www.sprinklr.com/legal

  • Carrier Access Billing System (“CABS”) is the system which is defined in a document prepared under the direction of the Billing Committee of the OBF. The CABS document is published by Telcordia in Volumes 1, 1A, 2, 3, 3A, 4 and 5 as Special Reports SR-OPT-001868, SR-OPT-0011869, SR-OPT-001871, SR-OPT- 001872, SR-OPT-001873, SR-OPT-001874, and SR-OPT-001875, respectively, and contains the recommended guidelines for the billing of access and other connectivity services. Sprint’s carrier access billing system is its Carrier Access Support System (CASS). CASS mirrors the requirements of CABS.

  • Surplus Interconnection Service means any unneeded portion of Interconnection Service established in an Interconnection Service Agreement, such that if Surplus Interconnection Service is utilized, the total amount of Interconnection Service at the Point of Interconnection would remain the same. Switching and Tagging Rules:

  • Generation Interconnection Customer means an entity that submits an Interconnection Request to interconnect a new generation facility or to increase the capacity of an existing generation facility interconnected with the Transmission System in the PJM Region.

  • Data Processing Equipment means any equipment, computer hardware, or computer software (and the lease or licensing agreements related thereto) other than Personal Computers, owned or leased by the Failed Bank at Bank Closing, which is, was, or could have been used by the Failed Bank in connection with data processing activities.

  • Network Data Mover (NDM) or “Connect Direct” means the industry standard protocol for transferring information electrically.

  • data user means a natural or legal person who has lawful access to certain personal or non-personal data and has the right, including under Regulation (EU) 2016/679 in the case of personal data, to use that data for commercial or non-commercial purposes;

  • Development Location Point means a single point selected by the Applicant on the proposed Development site that is located within 100 feet of a residential building existing or to be constructed as part of the proposed Development. For a Development which consists of Scattered Sites, this means a single point on the site with the most units that is located within 100 feet of a residential building existing or to be constructed as part of the proposed Development.

  • Demarcation Point means the point where Qwest owned or controlled facilities cease, and CLEC, End User Customer, premises owner or landlord ownership or control of facilities begin. "Designed, Verified and Assigned Date" or "DVA" means the date on which implementation groups are to report that all documents and materials have been received and are complete.

  • Data Processing Agreement means the data processing agreement located at xxx.xxxxxx.xxx/[countrycode]/legal/dpa, where “[countrycode]” means the two-letter abbreviation for the country where your Stripe Account is located.

  • Central fill pharmacy means a pharmacy contracting with an originating pharmacy, or having the same owner as an originating pharmacy, that provides centralized prescription drug order filling on behalf of the originating pharmacy pursuant to these rules.

  • END USER CUSTOMER LOCATION means the physical location of the premises where an End User makes use of the telecommunications services.

  • Attachment point means the amount of claims incurred by an insured group beyond which an insurer incurs a liability for payment.

  • Net metering customer means a customer of the electric distribution company

  • Data Use Agreement means the agreement incorporated into the Contract to facilitate creation, receipt, maintenance, use, disclosure or access to Confidential Information.

  • Generation Interconnection Agreement means the generation interconnection agreement to be entered into separately between Seller and PGE, providing for the construction, operation, and maintenance of interconnection facilities required to accommodate deliveries of Seller's Net Output.

  • Data Center(s) means the site or sites at which SAP Business One Cloud will be hosted to enable Partner to provide the Subscription Services to its End Users.

  • Transmission Interconnection Customer means an entity that submits an Interconnection Request to interconnect or add Merchant Transmission Facilities to the Transmission System or to increase the capacity of Merchant Transmission Facilities interconnected with the Transmission System in the PJM Region or an entity that submits an Upgrade Request for Merchant Network Upgrades (including accelerating the construction of any transmission enhancement or expansion, other than Merchant Transmission Facilities, that is included in the Regional Transmission Expansion Plan prepared pursuant to Operating Agreement, Schedule 6).

  • Interconnection Customer means a Generation Interconnection Customer and/or a Transmission Interconnection Customer.

  • Synchronous interaction means a real-time interaction between a patient and a health care provider for telehealth located at a distant site.

  • Office of the Interconnection Control Center means the equipment, facilities and personnel used by the Office of the Interconnection to coordinate and direct the operation of the PJM Region and to administer the PJM Interchange Energy Market, including facilities and equipment used to communicate and coordinate with the Market Participants in connection with transactions in the PJM Interchange Energy Market or the operation of the PJM Region.

  • Project Location means an individual Right-of-Way location (typically Street, Alley, Sidewalk, Intersection, or Path) identified to make up a whole Project;

  • Eligible customer-generator means a customer-generator whose net energy metering system for renewable resources, cogeneration, fuel cells, and microturbines meets all applicable safety and performance standards.