Technology Transfer Package definition

Technology Transfer Package means all information and data describing the Process, together with all Licensed Know-How, Materials and Media and Feeds necessary or useful for the development and manufacture of Client Product using the Licensed Cell Line and/or the Process.
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Technology Transfer Package means all Theravance Confidential Information and Theravance Know-How relating to: (1) the lead Theravance Compound in the relevant Alliance Program, as well as any back-up and follow up Theravance Compound for which Theravance in good faith believes there is sufficient in vivo data and which are part of such Alliance Program; (2) where applicable, all information regarding the bulk drug substance and finished dosage form(s) and methods of manufacturing the same, including without limitation analytical methods; and (3) the full disclosure of all information relating to the lead Theravance Compound and any such back-up Theravance Compound (including, where applicable and without limitation, clinical and protocol results, analytical methodologies, bulk and final product manufacturing processes, batch records, pre-formulation studies, reports summarizing development pharmaceutics, vendor information, validation documentation, regulatory documentation, patent information), regulatory filings, transfer of information related to regulatory information and filings, pre-clinical and clinical data, adverse event data, regulatory correspondence (including records of meetings and telephone conversations), analyses, and manufacturing data.
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Technology Transfer Package means all THERAVANCE Confidential Information and THERAVANCE Know-How relating to the Licensed Product, including all information regarding the API Compound and formulated Licensed Product in the Field and methods of manufacturing the same, analytical methods, specifications, batch records, batch testing and release results, results and reports of all pre-formulation studies, reports summarizing development pharmaceutics, vendor information, validation documentation, other quality management system documentation supporting manufacture and release, results and reports of all non-clinical, pre-clinical and clinical studies, adverse event data, patent information, regulatory documentation and filings, and regulatory correspondence. Section 1. 116 “Term” means, on a Licensed Product-by-Licensed Product basis and on a Country-by-Country basis, the period from the Effective Date until the later of (a) the expiration or termination of the last Valid Claim of a THERAVANCE Patent covering any Licensed Product in the Field, or (b) thirteen (13) years from First Commercial Sale anywhere in the Territory, unless this Agreement is terminated earlier in accordance with ARTICLE 13.
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Examples of Technology Transfer Package 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 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.

  • Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated.

  • An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.

  • 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.

  • As soon as reasonably practicable but in any event within [***] after the Effective Date of this Amendment, Theravance shall deliver to GSK existing stock of each Supplemental MABA Alliance Product as well as the Supplemental MABA Technology Transfer Package.

  • The Technology Transfer to Biovac will comprise of Technology Transfer Package 1, as described in Annex 3, called “mRNA technology for R&D” (hands-on and mandatory), which will be finalized once Phase 1 Clinical trial material is manufactured and released.

  • Solicit feedback, respond to any questions, and resolve any critical issues.• Responsible Party: The City/Consultant Task 3.6: Final Adaptation Plan• Complete the final report that addresses the comments given from Workshop #3 and the Joint Commission Meeting.

  • The details of the contents of the Technology Transfer Package shall be set forth in the applicable Joint Research Plan.

  • An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” will be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.


More Definitions of Technology Transfer Package

Technology Transfer Package means all Theravance Confidential Information and Theravance Know-How relating to:
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Technology Transfer Package means all available technical and regulatory information regarding the Manufacturing Technology owned or Controlled by Antigenics or its Affiliates as set forth in Phase 1 of the Technology Transfer Plan.
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Technology Transfer Package means the information and data to be provided to Licensee describing [***] that are necessary for Licensee to manufacture Licensee Product by using the applicable Licensed Cell Line and/or the Process.
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Related to Technology Transfer Package

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

  • 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;

  • 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;

  • Technology startup company means a for profit business that

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

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

  • Research Analyst means any individual employed by Loomis Sayles who has been designated as a Research Analyst or Research Associate by Loomis Sayles. A person is considered a Research Analyst only as to those Covered Securities which he or she is assigned to cover and about which he or she issues research reports to other Investment Persons or otherwise makes recommendations to Investment Persons beyond publishing their research. As to other securities, he or she is simply an Access Person.

  • Deliverables means the goods, services, and work product, including all reports and project documentation, required to be provided by Grantee to the System Agency.