Assessment and documentation. It is the company's obligation to assess whether products to be registered meet the system's criteria and to save assessments along with the documents used. To register a product in the BASTA-system, the company must fulfil the criteria described under the criteria area "Organisation" and the product must be assessed against all criteria under the criteria area "Health and environmental hazards". When registering, it must be stated which of the criteria the product meets, and which it does not. In order to make the assessment, the company must have complete documentation that shows whether the content of the product meet the criteria. How assessment is to be carried out and how assessment data is to be handled is described in criteria O2: "Assessment and documentation" in the criteria area "Organisation” in the BASTA-systems criteria document.
Assessment and documentation. This stage involves, as necessary and applicable, (i) appointing the JSC, (ii) forming subteams with respect to specific aspects of technology transfer, (iii) each Party establishing contacts with the technology transfer counterparts at the other Party, and (iv) the transfer by Licensor materials as set out below including but not limited to
Assessment and documentation. This stage involves, as necessary and applicable, (i) appointing the JTTC, (ii) forming subteams with respect to specific aspects of technology transfer, (iii) each Party establishing contacts with the technology transfer counterparts at the other Party, and (iv) the transfer by Alnylam of SOPs, presentations, and materials listed in Table 1 below. The transfer of the items described in Column J of Table 1 below will occur within [**] days after the Effective Date (the “Stage 1 Period”). Additional documents listed in Table 1 and to be further defined during the Technology Transfer Period will also be provided by Alnylam as available. Items to be transferred after the Stage 1 Period may include certain procedures for IND-enabling studies (such as toxicology, PMDK, CMC) which require assessing and confirming a large amount of content, and extra time is provided in the Technology Transfer Plan detailed below to accommodate such assessment and confirmation.
