Urology Business Information. Means the following business information and related records as in existence on the date hereof to the extent used in or applicable to the Urology Business: (i) documentation related to the design, validation, and production of the miniaturo current model of Bio Control Device, physician programmer, stimulation lead, system accessories, test fixtures and manufacturing fixtures; (ii) documentation related to the assembly of Bio Control Devices, including: (A) process flow charts, process
... standard operating procedures (SOPs), (B) copies of all equipment drawings and manuals, (C) calibration records for all equipment and other fixed assets; (D) sterilization cycle validation reports, (E) drawing of molds needed to manufacture parts for the miniaturo, (F) floor plan and equipment list for a facility capable of performing the manufacturing steps of the miniaturo currently performed by Bio Control, and (G) floor plan, equipment list and software list for a facility capable of performing the development process currently performed by Bio Control; (iii) lists of vendors and suppliers, including addresses and telephone numbers, if possible, and a breakdown of purchases by vendor or supplier; (iv) details of expected cost of goods sold and other manufacturing costs for Bio Control's current model of Bio Control Device; (v) draft marketing material (posters, procedure video, etc. ); (vi) lists of third party software used by Bio Control; (vii) all of Bio Control's preclinical and clinical data, including animal studies, and human clinical data, descriptions of protocols, adverse event reports, study reports and database copies (in printed or electronic format), as well as a list of investigational sites and principal investigators; (viii) all regulatory documents, including submissions, registrations and licenses; (ix) all Software, including Source Code; and (x) all invention records created by internal and external personnel not otherwise included in the Purchased Assets, as defined in the Asset Purchase Agreement.
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