MANUFACTURER DEVELOPMENT WORK Clause Samples

MANUFACTURER DEVELOPMENT WORK. Development, design and manufacturing of Product Molds based on specifications provided by RareGen; § Development, design and manufacturing of Products based on specifications provided by RareGen; § Other cooperation with and assistance to RareGen as reasonably necessary for the Project; § Perform all testing required for regulatory clearance with U.S. FDA, including but not limited to ISO 10993 sterility, shipping testing ASTM and environment conditions exposure, and full FAI testing of all critical dimensions. Manufacturer may waive testing requirements if they can substantiate previous completed testing is applicable to the Products. § Manufacture Products according to cGMP and in compliance with ISO13485 and U.S. FDA regulations; and § This product will be filed under our existing 510K for syringes, K132553. We will not be able to apply another 510K to indicate for use with CADD-MS 3 ambulatory infusion pump. We also will not be able to print on the label indicating this syringe is for CADD-MS 3 ambulatory infusion pump. Manufacturer will not be responsible for the product patent issues related to this product, manufacturer will only produce the products according to the purchaser’s requirements.