Traceability Program Sample Clauses

Traceability Program. BioForm shall be responsible for maintaining medical device vigilance systems in the Territory as required by laws applicable to distributors of products such as the Company Product, and shall provide Supplier with reasonable access to such records.
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Traceability Program. JV shall be responsible for maintaining medical device vigilance systems in the Territory as required of a distributor of products such as the Products by local regulations, and shall provide Medifocus with reasonable access to such records. Each party shall inform the other promptly if it becomes aware of any medical complaint required to be reported to any Regulatory Authority in the Territory.
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Traceability Program. ASI shall be responsible for maintaining the records required for the traceability of the distribution of the Products by part or catalog number and lot or serial number. All Products entered into commercial distribution shall be traceable to the end user with sufficient detail that product can be located and retrieved as may be required. ASI shall be responsible for maintaining medical device vigilance systems in the Field within the Territory as required by local regulations and/or applicable law, and shall provide OBI with reasonable access to such records. Each Party shall inform the other promptly if it becomes aware of any complaint regarding any Product o required to be reported to any Regulatory Authority in the Territory.
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Traceability Program. BSC shall be responsible for maintaining medical device vigilance systems in the Territory as required of a distributor of products such as the Products by local regulations, and shall provide Celsion with reasonable access to such records. Each party shall inform the other promptly if it becomes aware of any medical complaint required to be reported to any regulatory authority in the Territory.
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Traceability Program. The manufacturer shall have in place a computer maintained traceability program that provides for the assignment of a production control number to each garment. The traceability program must be capable of tracing the garment through production, from the bolts of cloth used in all three layers of the garment composite construction, to the assignment of the garment to the individual firefighter. This production control number shall be visibly located on the garment label and on other protected areas of garment.
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Traceability Program. Supplier shall cooperate with MTI, as requested, in the implementation by Supplier of a Product traceability program that reasonably satisfactory to MTI. Supplier shall engage in continuous improved quality performance including but not limited to adherence to the following items:
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Traceability Program. The manufacturer shall FURNISH TO THE END USER and have in place a computer maintained traceability program which allows for the assignment of a production lot number to each element. The traceability program must be capable of tracing the element through assignment to the individual firefighter. When additional product traceability is requested in the Custom Options section, an additional label shall be attached to the element which contains an individualized serial number.
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Traceability Program. BSC shall be responsible for maintaining medical device vigilance systems in the Territory as required of a distributor of products such as the Company Products by local regulations, and shall provide AMS with reasonable access to such records. AMS and BSC shall inform the other immediately if it becomes aware of any medical complaint required to be reported to any Regulatory Authority in the Territory. AMS shall promptly notify BSC in writing if it becomes aware of any issue relating to the safety or efficacy of any Company Product including, without limitation, such Company Product's manufacture, labeling or packaging.
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Traceability Program. 14 SECTION 4.04 Recalls...............................................14 SECTION 4.05 Notices...............................................15
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Related to Traceability Program

  • Traceability 11.1 Under the terms of this Agreement, Supplier shall have and operate a process to ensure that all Products, sub-assemblies and the components contained therein supplied to the Buyer are completely Traceable back to manufacturer by batch or lot or date code.

  • Compatibility 1. Any unresolved issue arising from a mutual agreement procedure case otherwise within the scope of the arbitration process provided for in this Article and Articles 25A to 25G shall not be submitted to arbitration if the issue falls within the scope of a case with respect to which an arbitration panel or similar body has previously been set up in accordance with a bilateral or multilateral convention that provides for mandatory binding arbitration of unresolved issues arising from a mutual agreement procedure case.

  • Customer Service A. PRIMARY ACCOUNT REPRESENTATIVE. Supplier will assign an Account Representative to Sourcewell for this Contract and must provide prompt notice to Sourcewell if that person is changed. The Account Representative will be responsible for: • Maintenance and management of this Contract; • Timely response to all Sourcewell and Participating Entity inquiries; and • Business reviews to Sourcewell and Participating Entities, if applicable.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

  • Hardware and Software Requirements In order to access and retain Disclosures electronically, you must satisfy the following computer hardware and software requirements: access to the Internet; an email account and related software capable of receiving email through the Internet; a web browser which is SSL-compliant and supports secure sessions, and hardware capable of running this software.

  • Review Systems The Asset Representations Reviewer will maintain and utilize an electronic case management system to manage the Tests and provide systematic control over each step in the Review process and ensure consistency and repeatability among the Tests.

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