Quality Compliance. CATALYTICA will provide CEPHALON 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. 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. R2 agrees that on-site quality control audits may be made, at GEMS's expense, by GEMS personnel or by an independent expert quality control auditor who is selected by GEMS. Such audits will be scheduled at reasonable times and upon reasonable prior notice to R2, and may be made once a year. Interim audits based upon a showing of good cause as a result of significant quality issues may be conducted but may be limited to those aspects of the R2 Quality System directly related to those quality issues. R2 agrees to furnish, at GEMS's sole expense, facilities, Quality System records, and assistance reasonably necessary to facilitate any such audit and ensure the safety and convenience of each inspection. R2 shall notify GEMS within a reasonable period of time (not later than 10 days) if the FDA or another regulatory body with authority over medical devices contacts R2 to inquire about or investigate the R2 Product. R2 shall notify GEMS if FDA inspects the R2 facility and shall provide GEMS with copies of FD-482 and FD-483 if related to the R2 Product. R2 agrees to provide GEMS a draft of any response that R2 intends to provide to FDA to address issues identified in FD-483, if related to the R2 Product, prior to submission. R2 shall provide GEMS two days to review and comment on such drafts. R2 shall provide GEMS with a copy of the final response to issues identified in FD-483, if related to the R2 Product. R2 shall notify GEMS if it receives a Warning Letter or other adverse regulatory action including, but not limited to, administrative detention, import detention, complaint for forfeiture, or complaint for injunction, if related to the R2 Product. R2 shall provide GEMS with any response R2 prepares in response to any adverse regulatory action, if related to the R2 Product. GEMS shall notify R2 within a reasonable period of time (not later than 10 days) if the FDA or another regulatory body with authority over medical devices contacts GEMS to inquire about or investigate the R2 Product. GEMS shall notify R2 if FDA inspects the GEMS facility if such inspection is related to the...
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. 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. Maintains a thorough knowledge of manufacturing processes, equipment, fixtures, and products to produce products to meet customer requirements. Supports, trains, and documents training to ensure compliance to ISO and other required production standards. Shows a commitment to quality and helps to assure all team members are focused on achieving Xxxxx’s quality objectives and goals.
Quality Compliance. Alvotech shall notify Teva within [***] of discovering any deviations that would (or reasonably would be expected to) materially impact the quality of a Product in the Territory, being deviations regarding Manufacture, Packaging or Labeling of the Product that would be (or reasonably expected to be) reported to the FDA and/or under the EMA Rapid Alert System.
Quality Compliance. Columbia Tech must have in place a viable Quality System; ISO 9001:2008 or ISO 13485:2003, with exclusions. Columbia Tech agrees to provide documented certification to these industry standards or to allow Customer to perform an audit to determine such conformity. For avoidance of doubt, Columbia Electrical Contractors, Inc. d/b/a Columbia Tech currently has in place an ISO 9001:2008 with exclusions and Cogmedix, Inc. has in place an ISO 13485:2003 with exclusions. Columbia Tech agrees to notify Customer in writing within thirty (30) days of any significant changes in the following area: • Company Ownership • Senior Organizational Structure • Interruption of supply chain for raw materials which may impact confirmed PO’s deliveries. • Manufacturing locations • Changes in outsourced processes • Quality System Registrations
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. -------------
Quality Compliance. SEL will provide NABRIVA with timely notification of all significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the Key Intermediate, as well as all FDA or other applicable regulatory authority reports regarding testing, manufacture, bulk packaging or labeling of the Key Intermediate.
