Quality Control Requirements. To the extent this Agreement requires Contractor to provide processed food products, all food products shall be processed in a plant with well documented comprehensive in-house quality control and HACCP Programs that are third party certified as set forth in more detail below. The District reserves the right to determine whether or not the Contractor has complied with these product specifications in its sole discretion. If the District determines that the Contractor has provided a good and/or service that does not comply with these specifications, the District may 1) refuse to accept the good and/or service at no cost to the District, 2) require goods that have already been delivered and accepted by the District to be replaced at Contractor’s expense, 3) require services that have already been performed in a manner that does not comply with Agreement to be corrected at Contractor’s expense, 4) require the Contractor to reimburse the District for the cost of the nonconforming goods and/or services, 5) order replacement goods (if Contractor cannot timely provide conforming replacement goods) and order replacement goods from another vendor and charge Contractor the difference between the price listed in Schedule A and the amount the District had to pay the other vendor for the substitute goods, 6) declare Contractor in breach of this Agreement, 7) suspend the performance of this Agreement until the breach is cured and/or 8) terminate this Agreement for cause.
Quality Control Requirements. Each Party acknowledges the other Party’s exclusive ownership of the other Party’s Trademarks and that use by either Party or its Affiliates of any of the other Party’s Trademarks, including any resulting goodwill, will inure to the sole benefit of the Party that owns such Trademarks. Neither Party will knowingly do or permit to be done, and will cause its Affiliates not to do or cause to be done, any act or thing inconsistent with such ownership and will not acquire or claim or assist third parties in acquiring or claiming any title in or to any of the other Party’s Trademarks, including by virtue of the Strategic Alliance Agreement, this OEM Agreement, or through either Party’s use of the other Party’s Trademarks. Neither Party will directly or indirectly, and will cause its Affiliates not to directly or indirectly, undertake any action that in any manner might question, contest, challenge, infringe or impair the validity, enforceability, scope of rights or title of the other Party in any of the other Party’s Trademarks at any time during the term of the Strategic Alliance Agreement. Each Party agrees that (a) all Combined Offerings identified by any of the other Party’s Trademarks will be at least equal in quality to the mutually agreed specifications therefore (the “Quality Standard”) and (b) it will maintain, and will cause its Affiliates maintain, procedures to assure the consistent quality of all Combined Offerings bearing or containing the other Party’s Trademarks. Each Party will have the right to audit and inspect, upon advance written notice, at the inspecting Party’s sole expense, and during regular business hours, the use by the other Party and its Affiliates of its Trademarks licensed hereunder and all Combined Offerings identified by any of its Trademarks (f)
Quality Control Requirements. In furtherance of the foregoing, any use by any of the Parties or any of their Subsidiaries or Affiliates of any of the Tyco Trademarks or Other Party Marks as permitted in this Section 5.2 is subject to their compliance with the quality control requirements and guidelines in effect for the Other Party Marks as of the Effective Time
Quality Control Requirements. The Contractor’s and subcontractor’s Quality Control Plans (QCPs) are subject to the acceptance by the Employer. The Contractor ensures that all specifications and requirements are communicated to the relevant parties in his organisation and does not deviate from it. All Contractor’s QCPs are accepted by the Project Manager, the Contractor and the Employer’s Appointed Inspection Authority / QA representative (as applicable) prior to the commencement of work. Only after acceptance of these documents by the Project Manager and the Employer’s QA representative / AIA as applicable, may the work proceed. The Contractor ensures that all work (Contractor and subcontractor work) is carried out in accordance with the QCPs or any other specifications through written instructions from the Project Manager. All documentation has a clearly stated revision number and previous similar documentation is revoked. All quality related problems / issues are reported and resolved as Defects in terms of Core Clause 42.2. Refer to the TRSs specifying the grades of non-conformances. All completed work is signed off in the QCPs as the work progress and all the relevant signatures are made on the documentation. The Contractor and his subcontractor employ quality control representatives, with appropriate proven experience.
Quality Control Requirements. Quality Control Requirements shall mean that JULPHAR shall subject all Active Ingredient to quality control inspections using quality control procedures, specifications, and systems to assure strict compliance with the Specifications and absence of defects.
Quality Control Requirements. In keeping with OCD Quality Assurance and Control Requirements and the provisions of ISO 13485, SNBTS shall comply with all of the provisions of the Quality System Agreement between SNBTS and OCD. In the event of a conflict in terms between this Umbrella Agreement and the Quality System Agreement, the Umbrella Agreement shall control.
Quality Control Requirements. Identify and discuss the procedures that will be used to review, modify, and approve plan documents and associated permits. Include methods and procedures to control, document, and accept the quality of the design activities listed in Section IV of the Special Provision titled SPECIAL BIDDING – DESIGN- BUILD. Include the following quality control items as a minimum:
Quality Control Requirements. Provide a response detailing the quality control plan and how it will be implemented to assure the individual facilities are maintained in the proper condition and “facility up-time” is maximized. “Facility Up-time” shall be defined as the reliability of system operation that provides users with services at scheduled times and for required durations. The response shall include the proposed inspection techniques, frequencies, continuous process improvements, documentation, corrective action, any proposed use of automated QC systems, and the Reliability Centered Maintenance (RCM) strategy.
Quality Control Requirements. Quality of services : Should be in compliance with our Technical Specification given SECTION VII.
Quality Control Requirements. Quality Control Requirements shall mean that Interquim shall subject all Active Pharmaceutical Ingredient to quality control inspections using quality control procedures, specifications, and systems to assure strict compliance with the Specifications and absence of defects. Drug Master File (“DMF”). Interquim shall provide the appropriate authorizations to each applicable Governmental Authority allowing Company the right to reference all Drug Master Files to apply for, obtain and maintain any Market Authorization Approval or other regulatory approvals for the Product. Interquim shall correct any deficiencies of such Drug Master File identified by any Governmental Authority in a prompt and efficient manner so as to prevent any delay in Company obtaining regulatory approval for a Final Product. In addition, Interquim shall be responsible for maintaining such Drug Master File in accordance with all Applicable Laws and ensuring that all data and information incorporated therein is accurate and current as necessary to support obtaining and maintaining the applicable Market Authorization Approvals and regulatory filings by Company. Active Pharmaceutical Ingredient Release. No Active Pharmaceutical Ingredient shall be released to Company without a Certificate of Analysis and Certificate of cGMP Compliance, both of which shall be supplied to Company by Interquim, (a) stating that the Active Pharmaceutical Ingredient being shipped has been tested and conforms to the Specifications and Quality Control Requirements, (b) confirming compliance with cGMP, the FD&C Act and all other Applicable Laws, rules, and regulations. Delivery Terms. Shipment of the API will be to a location according to the incoterm chosen by the Parties, which shall also regulate the payment of carrier, freight charges, title and risk of loss. The API will be shipped with the requisite packing slip, Certificates of Analysis, and Certificate of cGMP Compliance. Exhibit 10.25 Interquim shall promptly notify Arcutis (within a maximum of ten working days) of any regulatory or cGMP violations (e.g. FDA Warning Letter or suspension/withdrawal of one or more CEPs or critical and major findings) identified during authority cGMP inspections and impacting the quality of Roflumilast intended to be shipped to the Company and/or potentially affecting the ability of Interquim to produce or ship Roflumilast, and shall co-operate with the Company in the scheduling of any planned inspection concerning Roflumilast....
