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.
Examples of Technology Transfer Package in a sentence
Technology Transfer Package is defined as the required information for the LICENSEE to be able to produce and manufacture THE PRODUCTS as defined in the MASTER LICENSE AGREEMENT when used with the LICENSEE's PRODUCTS.
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.
Upon the written request of Tibotec, Gilead shall prepare a written technology transfer package of Gilead Region C Know-How and Joint Region C Know-How available to Gilead (the Generic Technology Transfer Package).
Section 6.14 of the Agreement is hereby inserted as follows:6.14 Technology Transfer Package.
Section 6.14 of the Agreement is hereby inserted as follows: 6.14 Technology Transfer Package.