9.1.1. In the event of a dispute between BAXTER and IDEC regarding the non-conformity of a batch of the PRODUCT, the quality managers of the two companies will immediately attempt, in good faith, to reach an agreement. Regardless of the result, IDEC reserves the absolute right to determine the release status of the product. Financial responsibility is defined in the delivery contract. The contract expires at the end of the delivery contract. The agreement may be amended, if necessary, with the written agreement of both parties. Sign up for Clause or contact distribution to use Smart Clause templates in your legal agreements. 7.2.1 In the event that BAXTER agrees that a product is not compliant or the laboratory finds that the shipment of the product is not compliant, BAXTER replaces that non-compliant product within (a) [CONFIDENTIAL TREATMENT REQUESTED] after receipt of the corresponding spare part(s) provided by the CUSTOMER or b) [CONFIDENTIAL TREATMENT REQUESTED] from the date of non-compliance by the third party or BATER`s consent to such non-conformity. In the second phase, a new Smart Clause model will be integrated into the clause platform so that it can be inserted into an agreement with you and your counterparty. After completing your Smart Clause template in Studio, click Export at the bottom left to download the Smart Clause as a CTA file. Then import the CTA file into your private template library on the Clause platform. Log in to Clause and click Templates, then select links on your private organization library page and upload your CTA file.
6.1.1. The product testing activities to be carried out by BAXTER must comply with the specifications of the delivery contract. As a general rule, BAXTER is responsible for performing tests and trials directly related to the bottling process. i.e. identity verification, uniformity by weight variation, bioburides before filtration, bulk sterility and finished product, etc., or as stipulated by other agreements between IDEC and BAXTER in the master plan of the product. In general, IDEC is responsible for the NON-SET AND STABILITY tests related to the conjugated antibody component and the non-biological components of KIT PRODUCT. BAXTER is responsible for sending unincluded and finished product samples to a mutually agreed external contract laboratory, such as Lancaster Laboratories for sterility testing. BAXTER is not a subcontractor without the prior authorization of IDEC. 5.1.2. PRODUCT`s manufacturing schemes are generally described in the product master plan. IDEC will inform BAXTER, as soon as it is economically acceptable, of a proposed substantial modification of the manufacturing plans that will be made and submitted on the sheet or license of the PRODUCT. The implementation of these changes is managed as described in 1.21 “Master Batch Record” means the formal set of instructions for the production of each kit or kit component.
The Master Batch Record for the manufacture of the 2B8-MX-DTPA conjugated antibody vial is shown in Figure 4. The Master Batch Record for any other kit component is the formal set of instructions, 1.21 for the manufacture of such a kit component that is mutually acceptable to the parties and (unless otherwise agreed in writing between the parties) contains all the contents of the batch data set that the BAXTER CUSTOMER has previously provided for this kit component. . . .