DOCUMENT CHANGE PROCEDURE. Chiron, in its sole discretion, will determine whether or not to modify BPDs, MPDs and/or SOPs to incorporate changes to specifications and procedures requested by BMPI. Any such modifications will be charged at the Additional Services Rate. Chiron will notify BMPI prior to implementing any change that reasonably would be expected to have an impact on the process, procedures, facilities, equipment, systems, starting materials, ingredients, packaging or testing materials involved in the production or testing of Product. TABLE 3.2: PROCEDURES ILLUSTRATIVE ONLY CHIRON: -------------------------------------------------------------------------------- PROCEDURE # TYPE PROCEDURE TITLE -------------------------------------------------------------------------------- ANALYTICAL -------------------------------------------------------------------------------- ** -------------------------------------------------------------------------------- MANUFACTURING -------------------------------------------------------------------------------- ** -------------------------------------------------------------------------------- GENERAL -------------------------------------------------------------------------------- ** -------------------------------------------------------------------------------- ** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 2 contracts
Sources: Manufacturing Agreement (Biomimetic Therapeutics, Inc.), Manufacturing Agreement (Biomimetic Therapeutics, Inc.)