Quality and Regulatory. Suppliers shall comply with any additional Quality and Regulatory obligations as identified by LABORIE, including completion of a separate Quality Agreement if applicable.
Quality and Regulatory
Quality and Regulatory Sample Clauses
Related to Quality and Regulatory
Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are 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 accurate and complete in all material respects and fairly presents the data derived from such studies, 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 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”); 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 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, regulations and policies of the Regulatory Agencies.
Financial Viability and Regulatory Compliance 2.6.1 Contractor warrants and represents that its corporate entity is in good standing with all applicable federal, state, and local licensing authorities and that it possesses all requisite licenses to perform the services required by this contract. Contractor further warrants and represents that it owes no outstanding delinquent federal, state or local taxes or business assessments. 2.6.2 Contractor agrees to promptly disclose to the MPHA any IRS liens or licensure suspension or revocation that may adversely affect its capacity to perform the services outlined within this contract. The failure by Contractor to disclose such issue to the MPHA in writing within 5 days of such notification received will constitute a material breach of this contract. 2.6.3 Contractor further agrees to promptly disclose to the MPHA any change of more than 50% of its ownership and/or any declaration of bankruptcy that Contractor may undergo during the term(s) of this contract. The failure of Contractor to disclose any change of more than 50% of its ownership and/or its declaration of bankruptcy within 5 days of said actions shall constitute a material breach of this contract. 2.6.4 All disclosures made pursuant to this section of the contract shall be made in writing and submitted to MPHA within the time periods required herein.
Statutory and Regulatory Compliance Contractor shall comply with all laws and regulations applicable to the Community Development Block Grant-Disaster Recovery funds appropriated by the Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), including but not limited to the applicable Office of Management and Budget Circulars, which may impact the administration of funds and/or set forth certain cost principles, including the allowability of certain expenses.
Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.
Legal and Regulatory Compliance 4.22.1 During the term of this Contract, Contractor must comply with all local, state, and federal licensing, accreditation and registration requirements/standards, necessary for the performance of this Contract and all other applicable federal, state and local laws, rules, and regulations. 4.22.2 While on the HCA premises, Contractor must comply with HCA operations and process standards and policies (e.g., ethics, Internet / email usage, data, network and building security, harassment, as applicable). HCA will make an electronic copy of all such policies available to Contractor. 4.22.3 Failure to comply with any provisions of this section may result in Contract termination.
Product Warnings As of the Effective Date, all Products CORE sells and/or distributes for sale in California which do not qualify as Reformulated Products, will bear a clear and reasonable warning pursuant to this Section. CORE further agrees that the warning will be prominently placed with such conspicuousness when compared with other words, statements, designs or devices as to render it likely to be read and understood by an ordinary individual under customary conditions of use. For purposes of this Settlement Agreement, a clear and reasonable warning for the Products shall consist of a warning affixed directly to the product or product packaging, label, or tag, for Products sold in California and containing one of the following statements: WARNING: Reproductive Harm- xxx.X00Xxxxxxxx.xx.xxx OR WARNING: This product can expose you to chemicals, including DEHP, which are known to the State of California to cause birth defects or other reproductive harm. For more information go to xxx.X00Xxxxxxxx.xx.xxx
Labelling The distributor, on behalf of the selected vendor agrees that all supplies of articles should invariably contain the following information on its label and the carton. One information should not be overlapped by any other information needed to be furnished. The label should contain : a. Name of the item as approved b. CMS Cat. No. c. Manufacturing date/Import date for the imported items. d. Expiry Date. (where applicable) e. Name & address of Registered Office of Manufacturers and place of manufacture. f. Manufacturing License Number. (where applicable for Manufactures) g. Batch Number (where applicable) h. Month and Year of supply. i. The label & Carton must invariably marked “W B. GOVT SUPPLY : NOT FOR SALE”. j. All Surgical items quoted/supplied by the tenderer must conform to IS /BIS /CE/USFDA. Pacemker must conform to CE & US FDA norms. In case of Drugs items quoted /supplied by tenderer MUST CONFORM TO IP, BP, or USP norms and N.F.I. –III specification as noted against the item(s) in catalogue as applicable. k. The MRP and Trade Name will not be allowed to be printed in any pack. This will lead to cancellation of candidature straightaway. However, for excisable products, insertion of writing of Govt MRP is allowed as per provision laid down in the order of the Central Excise dept. However, for imported item(s), MRP and Trade name may be allowed in addition to Generic name.
Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.
Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.
Packaging and Labeling Seller shall properly xxxx, xxxx, and ship Goods and provide Buyer with shipment documentation showing the Order number, Seller’s identification number for the subject Goods, the quantity of goods in shipment and the number of cartons or containers in the shipment.
