In accordance with 21 CFR 601.12, changes made to an approved application, and as agreed by both parties, BAXTER will provide documentation to support zevalin Biologic License Application (BLA). The BLA documentation consists of two main parts; information on chemistry, production and control and information on the description of the operation. This documentation may contain a copy of each of the following statements: 1.31 „Regulatory Plan“ refers to the plan that includes regulatory services and support for regulatory bids and supporting documentation for the production of schedule 9 products, which are amended, supplemented or amended by written agreement between the parties. 26.1 This agreement, associated with the product master plan and confidentiality agreement, constitutes the entire agreement between the parties regarding the purpose of this agreement and replaces all previous written or oral agreements, agreements and assurances relating to them. NOW, THEREFORE, in light of the reciprocal agreements and agreements contained in this agreement, the parties agree that if both agreements contain provisions on the same subject, they must be carefully considered if one of the agreements is amended at a later date. 10.1 All proposed amendments are subject to a technical, regulatory and cGMP impact assessment by baxter expert groups. Documents containing IDEC`s intellectual property or changes that may affect IDEC`s regulatory submissions will also be used in accordance with the IDEC-BAXTER agreements for the evaluation of IDEC for regulatory advice and implementation requirements. 1.10 „confidentiality agreement“ refers to the confidentiality agreement signed by CLIENT and Baxter Healthcare Corporation on December 10, 2001 and forwarded to BAXTER on January 1, 2002, as amended below, and in the amended versions, supplemented from time to time by the written agreement of the parties, amended, supplemented or reproduced. 1.21 „Master Batch Record“ refers to the formal set of instructions for the manufacture of each kit or kit component. The Master Batch Record for the production of the 2B8-MX-DTPA conjugate antibody bottle is available at Appendix 4. The Master Batch Record for the other kit component is the formal set of 1.21 instructions for the manufacture of such a kit component which is acceptable to the parties for both parties and which contains (unless the parties otherwise agree in writing) all the contents of the lot data set that client BAXTER has previously made available for this kit component.
The parties make reasonable economic efforts to finalize the master batch record for the other kit component within twenty-one (21) calendar days following the validity date (but at least before the preparation of a stability/validation batch for a kit component).