Manufacturer Responsibility. If Boeing determines that the Interface Problem is primarily attributable to the design of an item not manufactured to Boeing's detailed design, Boeing will assist Buyer in processing a warranty claim against the manufacturer of such item.
Manufacturer Responsibility. In the event Santarus rejects Finished Products in accordance with this Section 3.5 and the rejected Finished Product is determined not to conform to the Manufacturer Manufacturing Responsibilities, Manufacturer will credit Santarus’ account for Manufacturer’s invoice price to Santarus for such non-conforming Finished Products. If Santarus shall have previously paid for such defective Finished Products, Manufacturer shall promptly, at Santarus’ election, either: (i) refund the invoice price for such defective Finished Products; (ii) offset such amount against other amounts due to Manufacturer hereunder; or (iii) use its best efforts to replace such Finished Products with conforming Finished Products as soon as reasonably possible without Santarus being liable for payment therefor under Section 6.3. Further, Manufacturer shall reimburse Santarus for all reasonable shipping, handling and storage charges incurred in association with such non-conforming Finished Product and for the Bulk API utilized in such non-conforming Finished Product in accordance with Section 2.11. Nothing in this Section 3.5.3 shall be construed to limit the rights and remedies available to Santarus at law or in equity.
Manufacturer Responsibility. So long and insofar as necessary to permit it to perform its obligation hereunder, Manufacturer shall maintain or obtain all Manufacturing registrations/validations and records required by applicable Competent Authorities in order for the Facility to Manufacture Products for sale in each country in which Products are sold to end users and provide QLT USA with access to all regulatory records required to be filed with the FDA or any other applicable Competent Authority, including its Annual Registration of Drug Establishment (form FDA 2656e) and its Annual Registration of Device Establishment (form FDA 2891a) granted by the FDA updated and in good order and will make the license and copies of all related documents available to QLT USA and its designees for inspection, upon reasonable request and in accordance with Section 5.04. Manufacturer shall file and maintain a facility master file as required by the FDA and maintain Product complaint files pursuant to applicable federal regulations. Manufacturer will be further responsible for promptly notifying QLT USA of all communications from any Competent Authority that may impact or change the ---------- ** Confidential Treatment Requested. Manufacturing Process. QLT USA shall pay, or promptly reimburse Manufacturer for, all costs associated with complying with this Section 6.02.
Manufacturer Responsibility. Manufacturer shall be responsible to ensure that its Processing and Packaging, the Facility, Manufacturer’s Equipment and systems meet regulatory requirements for cGMPs for the United States of America, the European Union and Taiwan, Republic of China. Manufacturer shall be responsible for Validation of its Facility, Manufacturer’s Equipment, Processing and Packaging processes and the costs of such Validation shall be absorbed by Manufacturer and/or agreed to in writing by Customer. Customer shall be responsible for all costs related to the Validation of Customer’s Equipment and any testing methods that apply solely to any Products. In addition, Manufacturer shall be responsible for all necessary education and training of its employees in regards to the Facility, Equipment, Processing and Packaging, and testing methods that apply to each specific Product. The costs of such education and training will be absorbed by Manufacturer. Subject to Section 5.1, Manufacturer shall be responsible for storage of all API and/or Intermediate Product, Raw Materials, Containers, Components and Labeling, and Processing and Packaging, holding, release testing and storage of the Product in accordance with (a) Manufacturer’s internal systems and standard operating procedures relating to quality assurance in its manufacturing operations, and (b) the specific Product Specifications.
Manufacturer Responsibility. If Seller determines that the Interface Problem is primarily attributable to the design of an item not manufactured to Seller's detailed design, Seller will assist Buyer in processing a warranty claim against the manufacturer of such item. 4.
