20 Dec 2020


Kit Component or Kit will be released by BAXTER Quality Assurance without BAXTER`s prior written consent and CLIENT`s consent for BAXTER reimbursement to the sentence set out in Part B of Schedule 7 to the amended tranche, supplemented or amended from time to time in accordance with Section 2.2.2, or the manner in which the parties agree in writing. 6.1.1. BAXTER`s PRODUCT verification activities must be in line with the specifications of the delivery contract. As a general rule, BAXTER is responsible for conducting tests and tests directly related to the bottling process; That is, identity verification, homogeneity by weight variation, prefiltrated bioburdes, mass infertility and finished products, etc., or, alternatively, by agreement between IDEC BAXTER and BAXTER in the material plan produced. In general, IDEC is responsible for product release and stability tests related to the conjugate component of antibodies and non-biological components of KIT PRODUIT. BAXTER is responsible for the transmission of unlabelled and finalized product test samples to a mutually agreed third-party contract laboratory, such as Lancaster Laboratories for sterility testing. BAXTER will not be allowed to conduct analytical testing without the prior approval of IDEC under contract. The contract expires at the end of the supply contract. The agreement can be amended if necessary with the written agreement of both parties. 1.2.1.

This agreement is part of the procurement agreement between the two companies and is an integral part of this agreement. 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 information: In the delivery agreement, you include the products you deliver, how often and when you deliver the products, what these products must meet, the price and payment conditions in which you deliver the products, the applicable delivery conditions (for example. B Incoterms), the warranties that apply to products and the extent to which your liability is extended. Depending on the payment terms, it may also be useful to include a property reserve in the delivery contract. In this way, you will remain the rightful owner of the products delivered until you have received the full payment for the products delivered. In addition, you can also include other conditions in the delivery contract, for example. B that the customer is required to purchase, must carry out a thorough review or other quality assurance agreements (they often have to be included in a separate quality assurance agreement). 4.1.3 BAXTER provides the CLIENT with the quantity of each product ordered by client for a calendar quarter, unless the quantity ordered for that quarter exceeds [CONFIDENTIAL TREATMENT TREATMENT REQUESTED] of the quantity of this product planned for this calendar quarter during the last rolling forecast, baxter making economically appropriate efforts to provide quantities exceeding the quantity of this product [CONFIDENTIAL TREATMENT REQUESTED] , for this calendar quarter in the most recent Rolling Forecast. Under no circumstances can the customer order and purchase during a calendar quarter less than [CONFIDENTIAL TREATMENT REQUESTED] of the quantity of this product scheduled for such a calendar quarter in the last “minimum amount” of “rolling forecast”.

In case orders and customer purchases less than I am often asked by customers to check business contracts on delivery relationships.

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