Batch Records. Talecris GmbH shall provide to ▇▇▇▇▇ a written report for each production batch (each a “Manufacturing Record”) for the purpose of complying with the registration and the documentation requirements of applicable Regulations, including without limitation, ED GMP Guidelines and of ED directive 91/356 article 9, as each may be amended from time to time, and any successors thereto.
Appears in 2 contracts
Sources: European Product Sales Agreement (Talecris Biotherapeutics Holdings Corp.), European Product Sales Agreement (Talecris Biotherapeutics Holdings Corp.)