Quality Compliance Clause Samples

Quality Compliance. [MANUFACTURER] will provide PURCHASER with timely notification of all significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the Product, as well as all FDA reports regarding testing, manufacture, packaging or labeling of the Product.

Quality Compliance. CIRCA will provide CEPHALON with timely ------------------ notification of all significant deviations, notes to file, and other deficiencies that may impact the quality of the Product, as well as all FDA reports regarding testing, manufacture, packaging, or labeling of the Product or the production facility.

Quality Compliance. Helsinn will provide Indevus with timely notification of all significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the API, as well as all FDA or other applicable Regulatory Authority reports regarding testing, manufacture, bulk packaging or labeling of the API.

Quality Compliance. R2 and GEMS shall each comply with their respective Quality ------------------- Systems which must be compliant with and regularly audited in accordance with 21 C.F.R. Part 820, Quality System Regulation, ISO 9001:1994, the applicable World Health Organization requirements and any applicable medical device regulations in the European Community, Japan, Australia, Canada, and South Africa.

Quality Compliance. Key Performance Indicators Performance Management requirements Meeting Schedule

Quality Compliance. Definition: Aggregated KPI based on UCB RAG. Complaints, level 1 deviation and repeated level 1 deviations are reported/trended separately.

Quality Compliance. ARENA will provide SIEGFRIED with timely notification of all significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the Products, as well as all reports from applicable regulatory authorities regarding testing, manufacture, packaging or labelling of the Products.

Quality Compliance. Patheon will provide Cephalon with timely notification of all significant deviations, notes to file, and other deficiencies that may be reasonably expected to impact the quality of the Products, as well as all FDA reports regarding testing, manufacture, packaging or labelling of the Products.

Quality Compliance. In addition to all other requirements of this ------------------ Agreement, Agent and each Provider must adhere to the quality of care monitors required by the terms of the Payor Plan and Master Agreement, including without limitation Attachment IV to the Payor Plan described in this Addendum, a copy of which is attached to this Addendum as Attachment II. -------------