Common use of Product Design Verification Clause in Contracts

Product Design Verification. Technical Design Inputs (TDIs) affected by the change on the length (57cm) will be tested by Cordis for the 36 new SRM Carotid Stent Delivery System catalogs - 57cm length project and will be based on length modification and size bracketing strategy. The only This that Cordis will test are as follows: • Usable length • Exit port location • MB Positioning • Stent pre-deployment • OM stoke length • Hub/hypotube pull strength • Hub/proximal wire pull strength • Wire lumen/Proximal wire/PET Sleeve pull strength • SM distal hypotube/proximal wire pull strength • Coil Stop pull strength For the avoidance of doubt, SRM will test TDIs for trackability and deployment force. Cordis will provide to SRM the following information (i) test method parameters and acceptance criteria Cordis uses to test Cordis’ PRECISE® Carotid Stent System for trackability and deployment force and which Cordis determines are applicable to the Product, and (ii) sample sizes Cordis uses to test Cordis’ PRECISE® Carotid Stent System for trackability and deployment force. Manufacture units for trackability and deployment force testing are included in the scope of the Development Fees up to the maximum number of units set forth in Exhibit 3 of the Supply Agreement. For the avoidance of doubt, TDIs that will not be tested by Cordis for the 36 new Carotid Stent Delivery System catalogs - 57cm length project are: • Crossing profile • Luer fitting • Air embolized • Ability to aspirate • Wire lumen ID • SDS Tip ID • Deployment accuracy • OM hub/hemovalve joint torque • Pod/body fuse joint pull strength & elongation • Brite tip/pod fuse joint strength • Wire lumen tip pull strength Design Verification (DV) & Product Performance Qualification (PQ) for the 36 new Carotid Stent Delivery System catalogs - 57cm length will be combined and will address qualification of the product. DV/PQ units will be subjected to three EtO sterilization cycles. Stability is not required as this product does not contain drug.

Product Design Verification. Technical Design Inputs (TDIs) affected by the change on the length (5765cm) will be tested by Cordis for the 36 18 new SRM Carotid Stent Delivery System catalogs - 5765cm length project and will be based on length modification and size bracketing strategy. ., The only This TDIs that Cordis will test are as follows: • Usable length • Exit port location • MB Positioning • Stent pre-deployment • OM stoke stroke length • Hub/hypotube OM hub pull strength • Hub/proximal wire OM Proximal OM Body elongation pull strength • Wire lumen/Proximal wire/PET Sleeve pull strength • SM distal hypotube/proximal wire pull strength • Coil Stop pull strength • Labeling content For the avoidance of doubt, SRM will test TDIs for trackability and deployment force. Cordis will provide to SRM the following information (i) test method parameters and acceptance criteria Cordis uses to test Cordis’ PRECISE® Carotid Stent System for trackability and deployment force and which Cordis determines are applicable to the Product, and (ii) sample sizes Cordis uses to test Cordis’ PRECISE® Carotid Stent System for trackability and deployment force; so that SRM can develop and validate its own test methods for trackability and deployment force. Manufacture units for trackability and deployment force testing are included in the scope of the Development Fees up to the maximum number of units set forth in Exhibit 3 of the Supply Agreement. For the avoidance of doubt, TDIs that will not be tested by Cordis for the 36 18 new Carotid Stent Delivery System catalogs - 5765cm length project are: • Crossing profile • Luer fitting • Air embolized embolization • Ability to aspirate • Wire lumen ID • SDS Tip ID TD • Deployment accuracy • OM hub/hemovalve joint torque • Pod/body fuse joint pull strength & elongation • Brite tip/pod fuse joint strength • Hub/hypotube pull strength • Hub/proximal wire pull strength • Wire lumen tip pull strength Design Verification (DV) & Product Performance Qualification (PQPPQ) for the 36 18 new Carotid Stent Delivery System catalogs - 5765cm length will be combined and will address qualification of the product. DV/PQ PPQ units will be subjected to three EtO sterilization cycles. Stability is not required as this product does not contain drug.