full data package definition

full data package means information and results of studies sufficient to satisfy the requirements of Annexes II and III to Directive 91/414/EEC in relation to a limited range of representative uses of the active substance concerned.
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full data package means, with respect to a completed Phase II Trial, all[*] data for such trial, including but not limited to[*] in such trial (such as, in the case of trials conducted for rheumatoid arthritis, all relevant data with respect to [*].
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full data package means with respect to each Compound: (a) any relevant information within Immunocore’s Control relating to such Compound(s), including all information regarding safety, efficacy, toxicity, or potential side effects, as well as all data collected from performing any pharmacokinetic, absorption, distribution, metabolism or excretion study, and toxicology studies, and any information resulting from or related to clinical trials, (b) any relevant data and information in Immunocore’s Control relating to the manufacture, formulation, and cost of goods for such Compound(s), and (c) any relevant documentation, filings, correspondence or other non-privileged information in Immunocore’s Control related to existing or potential Patents related to such Compound(s).. The format and depth of data to be provided in such Full Data Package to be mutually agreed to by the Parties.
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Examples of full data package in a sentence

  • If GNE notifies Immunocore that it wishes to be granted such rights, the Parties shall negotiate in good faith for a period of [***] from (a) the delivery of the Full Data Package to GNE, or (b) such [***] period as the Parties may agree, the financial terms under which GNE shall be granted such rights.

  • If GNE notifies Immunocore that it wishes to be granted such rights, the Parties shall negotiate in good faith for a period of [***] from (a) the delivery of the Full Data Package to GNE, or (b) such longer period as the Parties may agree, the terms under which GNE shall be granted such rights.

  • If GNE notifies Immunocore in writing prior to the end of such period, that it wishes to be granted the right to commercialise such Licensed Products then Immunocore shall provide to GNE the Full Data Package for such Licensed Products.

  • If GNE notifies Immunocore in writing prior to the end of such period that it wishes to be granted the right to develop and commercialise such Immunocore Products then Immunocore shall provide to GNE the Full Data Package for such Immunocore Products.

  • Until the date that is [***] after validation of the Full Data Package through the JSC, Licensor shall have the option to reclaim all exclusive rights to Exploit the Product in the Field in Option Territory and to obtain an exclusive sublicensable license in the Option Territory to Improvements, including Product trademarks, to Exploit the Product in the Field (the “Reversion Option”).


More Definitions of full data package

full data package means, with respect to each Other HLA/MAGE-A4 Compound: (a) any relevant information within Immunocore’s Control relating to such Other HLA/MAGE-A4 Compound(s), including all information regarding safety, efficacy, toxicity, or potential side effects, as well as all data collected from performing any pharmacokinetic, absorption, distribution, metabolism or excretion study, and toxicology studies, and any information resulting from or related to clinical trials; (b) any relevant data and information in Immunocore’s Control relating to the manufacture, formulation, and cost of goods for such Other HLA/MAGE-A4 Compound(s); and (c) any relevant documentation, filings, correspondence or other non-privileged information in Immunocore’s Control related to existing or potential Patents related to such Compound(s). The format and depth of data to be provided in such Full Data Package shall be mutually agreed to by the Parties.
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Related to full data package

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Work package means a major sub-division of the proposed project.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Sample means urine, blood, breath, saliva, or hair.

  • GSK will have the meaning set forth in the Preamble.

  • QA means quality assurance.

  • Package means the packaging together with its radioactive contents as presented for transport.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Diagnostic Product means a diagnostic product, containing one or more Program Materials, for use in the in vivo detection of any disease or condition in humans.

  • API means American Petroleum Institute.