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.

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.

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

• 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 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.

• 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.

• Amyris Brasil currently anticipates that the Technology Transfer Package will include the following: (i) biological materials, including the final Production Strains; (ii) written protocols and instructions; (iii) the final product composition; (iv) demonstration runs at an agreed-upon facility; (v) training; and (vi) ongoing support and consulting.

• Gilead will use comerically reasonable efforts to commence making such Technology Transfer Package available as expediently as practicable following request and in any event within 30 days of the request.

• Content of Technology Transfer Package 1 will be made accessible to Biovac as soon as information is available.

• 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.

• 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 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.

Technology Transfer Package means the information and data to be provided to Licensee describing the Process and Licensed Know-How, Materials and Media and Feeds for manufacture of Client Product using the Licensed Cell Line and/or the Process. 1.18 “Third Party” means any person other than the Parties to this Agreement. 1.19 “Third Party Manufacturer” means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product and/or Drug Substance by such Third Party for Licensee or such sublicensee.

Technology Transfer Package means all Theravance Confidential Information and Theravance Know-How relating to:

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.