Technology Transfer Package 3 definition

Technology Transfer Package 3 shall have the meaning described in Annex 3.
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Examples of Technology Transfer Package 3 in a sentence

  • The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).

  • Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted.

  • Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorization Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results are made available and the complete MAA dossier submitted.

  • Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results are made available and the complete MAA dossier submitted.

Related to Technology Transfer Package 3

  • Technology Transfer Plan has the meaning set forth in Section 4.1.5.

  • Technology Transfer has the meaning set forth in Section 5.2.

  • Technology Transfer Agreement has the meaning given in Section 2.2(a).

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Development Phase means the period before a vehicle type is type approved.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • Technology startup company means a for profit business that

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Data Package has the meaning set forth in Section 2.9(a).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Technology License Agreement means the agreement in the form of Exhibit H hereto.

  • 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.

  • Technical Support Services means the technical support and maintenance Services provided by us according to our then-current technical support policy and procedure listed at xxxxxxxxxxxxx.xxx (“Technical Support Policy”) when the Services are purchased.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Test Strategy means a strategy for the conduct of Testing as described further in paragraph 3 of Call Off Schedule 5 (Testing);

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.