You enter into a supply contract if you regularly supply products or services to another party (the supply contract has the character of a framework agreement), if you provide a product or service with high-risk content or a high price (e.B machines) or if you wish to establish a special relationship with your customer in any form. 6.1.1. The testing activities to be carried out by BAXTER for the PRODUCT must comply with the specifications of the supply contract. In general, BAXTER is responsible for carrying out tests and tests directly related to the filling process. i.e. identity verification, homogeneity due to unit weight fluctuations, biocharging before filtration, sterility of bulk and finished products, etc. or otherwise specified by agreement between IDEC and BAXTER in the product master plan. In general, CEDI is responsible for product release and stability testing related to the conjugated antibody component and non-biological components of the PRODUCT kit. BAXTER is responsible for sending bulk test samples and unmarked finished PRODUCTS for sterility testing to a jointly agreed third-party contract laboratory, such as Lancaster Laboratories. BAXTER will not subcontract analytical tests to subcontractors without the prior consent of IDEC. 1.1.2. This Agreement also defines how BAXTER Quality Operations and IDEC`s Quality Department will interact with each other.
1.31 “Regulatory Plan” means the Plan, which includes regulatory services and support for regulatory submissions and supporting documents for the manufacture of the Products, which are attached to Schedule 9, which is amended, supplemented or adapted from time to time by mutual written agreement of the Parties. A supply contract is a contract in which a supplier undertakes to supply certain goods and/or services to a buyer, whether exclusively a buyer or not. In the (international) market, a supply contract (in the form of a framework agreement) is often feasible because it specifies the conditions under which your customer can purchase products or services from you. Often, based on a so-called (rolling) forecast, your customer can then order the products or services via an order and you can take this into account in your (production) planning. If you include a minimum purchase obligation, you can also count on minimum sales. A manufacturing and supply agreement is essential for any company that distributes products manufactured by another entity. There are many possible provisions that your agreement may contain to better protect your assets and help you manage potential litigation in the future. 4.1.3 BAXTER will provide the CUSTOMER with the quantity of each Product ordered by the CUSTOMER for a calendar quarter, unless the quantity ordered for that calendar quarter exceeds [CONFIDENTIAL TREATMENT REQUESTED] the quantity of such Product planned for that calendar quarter in the last continuous forecast, BAXTER making commercially reasonable efforts to deliver quantities that exceed the quantity of such Product provided for this purpose above [CONFIDENTIAL TREATMENT REQUESTED] of the quantity of product provided for this. Calendar quarter in the last continuous forecast. Under no circumstances may Customer order and purchase less than [CONFIDENTIAL TREATMENT REQUESTED] during a calendar quarter of the quantity of this product planned for that calendar quarter in the last continuous forecast (the “Minimum Quantity”). In the event that the CUSTOMER orders and purchases less than your business is unique, the terms and clauses of your agreement must directly reflect your business model and the limitations of your manufacturer and supplier. The contract expires upon termination of the delivery contract.
The agreement may be amended if necessary with the written consent of both parties. 3.9.2 Mass conjugated antibodies and other component memories supplied by the customer. In no event shall Baxter be required to provide more than one [CONFIDENTIAL TREATMENT REQUESTED] of conjugated antibodies or other components supplied by CUSTOMER, calculated according to the latest rolling forecasts, without BAXTER`s prior written consent and CUSTOMER`s consent to reimburse BAXTER at the rate set out in Part B of Schedule 7, to save money. as amended, supplemented or adapted from time to time in accordance with section 2.2.2 or otherwise agreed in writing by the parties. 13.1.1. BAXTER conducts an annual product review for the PRODUCT and issues a report to CEDI. This report covers all manufacturing and testing activities carried out by BAXTER. It consists of a review of any changes at BAXTER in the manufacture, testing, storage, shipment or validation of the PRODUCT during the previous calendar year and a summary of the batches manufactured, released and rejected.
In addition, control diagrams and the summary of the most important product parameters are carried out. Any discrepancies are explained in the annual review. BAXTER will provide IDEC with the requested information each year from the beginning of commercial production. Trend analysis of environmental data will be available for review as part of the annual audits. 10.1 All proposed amendments are subject to a technical, regulatory and cGMP impact assessment by the BAXTER Expert Groups. Documents containing IDEC`s intellectual property or changes that may affect IDEC`s regulatory filings will also go through IDEC`s assessment for regulatory advice and implementation requirements under the agreements between IDEC and BAXTER. 8.2.3. Each Party undertakes to provide the other Party with all manufacturing, testing or storage data within 48 hours if necessary due to an official inspection or a potential regulatory risk such as a recall or a significant complaint about a product. .
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