After all, disputes arise more than any other provision of the contract when a party attempts to terminate the contract – whether for cause or convenience. The termination provision should clearly specify the circumstances in which the parties may terminate, the amount of notice to be given and the rights of the parties in the event of termination. I recommend introducing a supplier quality agreement at the beginning of the development phase. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. By educating your suppliers early and working productively with them at this point, you`ll avoid surprises later in the development cycle, when it`s too late to change a key component or vendor. While it`s important to provide long-term care and maintain the current configuration of a component critical to the design of your medical device, the process may need to become a little more complex. Typical components that can be subject to controls are those that come exclusively from practice or are essential to the performance or safety of your medical device. A supplier quality agreement or supply contract may be required. Here you need to list all the conditions under which the contract can be legally terminated.
Supply chain contracts are very diverse and complex, as the supply chains themselves are complex and encompass the entire product creation process. Your supply chain typically refers to the network of entities that bring a product from its design to its design, manufacture, sale, and delivery to the end user. Key players in supply chains may include manufacturers, distributors and suppliers of raw materials. Supply chain agreements with these and other participants include sales agreements, distribution agreements, reseller agreements, and manufacturing agreements. When it comes to compensation and exclusion of liability for consequential damages, attention should always be paid to the interaction of risk allocation provisions in a contract. For example, if the agreement includes full indemnification that states that the indemnifying party indemnifies the indemnified party for all losses arising from certain causes, and also includes a consequential disclaimer that provides that neither party is liable to the other party for consequential damages, the agreement has an inherent inconsistency that is not good for both parties, because none of them can depend on an outcome (i.e., the indemnified party does not know whether its reputational or other consequential damages will be compensated, for example, and the compensating party does not know whether it is liable for compensation for reputational damage or other consequential damages). As another example, third-party claims should generally be classified as consequential damages. If an agreement contains both compensation for third-party claims and a disclaimer for consequential damages, there is an internal conflict in the agreement that may leave it to a judge or jury to determine the outcome to which the parties intended. Therefore, it is important to ensure that contracts explicitly address how indemnification clauses and disclaimers interact with each other.
Laura Meyer is Head of Supply Chain at StarFish Medical. As a Lean facilitator, Laura helps optimize supply chains for prototypes and customer manufacturing. She is happy to share her expertise with her colleagues and clients. The supplier`s quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and GMP (Good Manufacturing Practices) obligations of the design owner and supplier. A quality agreement is an important part of a supplier qualification program, but it does not replace supplier qualification processes (including on-demand audits) or understanding of the supplier, its processes and capabilities. A quality contract must not contain commercial or liability clauses that should be dealt with exclusively in a supply contract. The provisions relating to force majeure are often overlooked by both parties when concluding a delivery contract. Often, the force majeure provision is merely a “copy and paste” of previous agreements, without taking into account the types of circumstances that may arise to the supplier that are beyond the seller`s control and that would in fact prevent performance. .