Food and Drug Sample Clauses

Food and Drug. Seller and all of its products have been at ------------- all times and continue to be in compliance with the Food, Drug and Cosmetic Act (the "Act") and all regulations promulgated thereunder by the United States Food --- and Drug Administration ("FDA") and equivalent foreign agencies except to the --- extent that noncompliance would not have a material adverse effect on Seller's business or the Purchased Assets. Without limitation on the foregoing representation and warranty, Seller further represents and warrants as follows, in each case except where the failure would not have a material adverse effect on the Purchased Assets or the Business: (i) Seller has properly filed pre-market notices ("PMNs") ---- under Section 510(k) of the Act for all products commercially distributed or introduced into interstate commerce for commercial distribution by Seller which require the filing of such notices. Seller has properly filed for and obtained a CE xxxx for its products and is in compliance with all requirements to maintain a CE xxxx for all of its products in all markets where the sale or marketing of its products has been approved and where the maintenance of the CE xxxx is required. (ii) Seller has been at all times and is in material compliance with all applicable FDA good manufacturing practices, equivalent foreign manufacturing processes and ISO 9002 compliance. (iii) Seller is registered with the FDA or equivalent foreign agencies, to the extent such registration is required by FDA regulations or the regulation of equivalent foreign agencies, and all of Seller's medical devices are listed with the FDA or equivalent foreign agencies to the extent such listing is required by FDA regulations or the regulations of equivalent foreign agencies. (iv) Seller has investigational device exemptions for all products requiring such exemptions, and such products have not been and are not being sold or distributed outside the terms of such investigational device exemptions. (v) To Seller's knowledge, Seller's marketed devices (A) have not caused or contributed to a death or serious injury, or (B) malfunctioned such that the device would be likely to cause or contribute to a death or serious injury. * Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. (vi) (A) Seller has no reason to believe that the FDA or any equivalent foreign agency will ultimately prohibit the marketing, sale, licens...
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Food and Drug. Except as could not reasonably be expected to result in a Material Adverse Effect, the Company and/or its Subsidiaries have all requisite permits, licenses, and approvals that are required under the Laws of the United States Food and Drug Administration (the “FDA”) (the “FDA Laws”) for the operation of the business of the Company and its Subsidiaries (collectively, the “FDA Permits”) and such FDA Permits (a) are valid and in full force and effect, (b) have not been reversed, stayed, set aside, annulled, or suspended and (c) are not subject to any conditions or requirements that are not generally imposed on the holders thereof. The Company and/or its Subsidiaries are in compliance with all applicable FDA Laws, including, without limitation, current good manufacturing practice requirements except as could not reasonably be expected to result in a Material Adverse Effect.
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Food and Drug. Wherever applicable, the Seller and all of its products have been at all times and continue to be in compliance with the Food, Drug and Cosmetic Act (the "FDC ACT") and the Public Health Service Act ("PHS ACT") and all regulations promulgated thereunder by the United States Food and Drug Administration ("FDA") and equivalent foreign agencies except to the extent that noncompliance would not have a material adverse effect upon the Business. Without limitation on the foregoing representation and warranty, the Seller further represents and warrants as follows: (i) The Seller is registered with the FDA, to the extent such registration is required by any FDA regulations. Purchaser, following due investigation, has assured itself that all exceptions and "grandfathering" from such registration and regulations currently available to Seller will be transferrable to Purchaser, and that Purchaser will not be required to seek or obtain any additional FDA registrations or approvals in order to operate the Business substantially in the manner operated by Seller as a result of the consummation of the transactions contemplated by this Agreement; and (ii) To the Seller's knowledge, the Seller's products have not (A) caused or contributed to a death or serious injury, or (B) been adulterated or misbranded such that the product would be likely to cause or contribute to a death or serious injury.
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Food and Drug. 12 s. Fair Consideration; No Fraudulent Conveyance.............. 13 t.
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Food and Drug. Except as could not reasonably be expected to result in a Material Adverse Effect, the Borrower and/or its Subsidiaries have all requisite permits, licenses, and approvals that are required under the Laws of the United States Food and Drug Administration (the “FDA”) and under the Laws of the applicable Governmental Authority for each jurisdiction in which the Borrower and its Subsidiaries manufactures, distributes or sells Inventory included in the Borrowing Base (collectively, the “FDA Laws”) for the operation of the business of the Borrower and its Subsidiaries (collectively, the “FDA Permits”) and such FDA Permits (a) are valid and in full force and effect, (b) have not been reversed, stayed, set aside, annulled, or suspended, and are not subject to any investigation by a Governmental Authority to revoke, stay, set aside, annul or suspend any such FDA Permits and (c) are not subject to any conditions or requirements that are not generally imposed on the holders thereof. The Borrower and/or its Subsidiaries are in compliance with all applicable FDA Laws, including, without limitation, those relating to the regulation of medical devices and current good manufacturing practice requirements except as could not reasonably be expected to result in a Material Adverse Effect.
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Food and Drug. To its Knowledge, the Seller Entity and all of the products and services which it imports, distributes, or provides are, and have at all times been, in compliance with the Food, Drug and Cosmetic Act and all regulations promulgated there under by the United States Food and Drug Administration.
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Food and Drug. ADMINISTRATION (FDA). We may disclose to the FDA health information relative to adverse events with respect to food, supplements, product and product defects, or post marketing surveillance information to enable product recalls, repairs, or replacement.
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Food and Drug. Set forth on Schedule 5.18 is a correct and complete list as of the Closing Date of all permits, licenses, and approvals that are required under the Laws of the United States Food and Drug Administration (the “FDA”) (the “FDA Laws”) for the operation of the business of the Company and its Subsidiaries (collectively, the “FDA Permits”) the failure of which to obtain could reasonably be expected to result in a Material Adverse Effect. Except as could not reasonably be expected to result in a Material Adverse Effect, the Company and/or its Subsidiaries have all requisite FDA Permits and such FDA Permits (a) are valid and in full force and effect, (b) have not been reversed, stayed, set aside, annulled, or suspended and (c) are not subject to any conditions or requirements that are not generally imposed on the holders thereof. The Company and/or its Subsidiaries are in compliance with all applicable FDA Laws, including, without limitation, current good manufacturing practice requirements except as could not reasonably be expected to result in a Material Adverse Effect.
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Food and Drug. Without limitation of Section 4.12, except as set forth on Schedule 4.19, Seller has been, and the Business has been conducted, in compliance in all material respects with the Food, Drug and Cosmetic Act, as amended (the "Act"), and all regulations promulgated thereunder by the United States Food and Drug Administration ("FDA"). Without limitation of the foregoing representation and warranty, Seller further represents and warrants as follows: (a) It has properly made all FDA filings under the Act for all products commercially distributed or introduced into interstate commerce for commercial distribution by Seller which require the filing of such notices. (b) Seller has been at all times and is in material compliance with all applicable FDA good manufacturing practices. (c) Seller is registered with the FDA, to the extent such registration is required by FDA regulations, and all of Seller's medical devices are listed with the FDA, to the extent such listing is required by FDA regulations. (d) Seller has investigational device exemptions for all products requiring such exemptions, and such products have not been and are not being sold or distributed outside the terms of such investigational device exemptions.
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Related to Food and Drug

  • Food and Drink (1) An employer must ensure that each child is provided with appropriate and sufficient nutritious food, having regard to the age, taste, culture and dietary restrictions of the child. (2) The food should be varied and should be served to children at reasonable hours. (3) An employer must ensure that water, fruit juice or other such drinks are readily available at all times to each child.

  • Alcohol and Drugs Service Provider agrees that the presence of alcohol and drugs are prohibited on the Work Site and while performing their Services. If the Service Provider or any of their agents, employees, or subcontractors are determined to be present or with alcohol or drugs in their possession, this Agreement shall terminate immediately.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • No Drugs All District properties are drug-free zones.

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • Medicines To be filled in if your child requires medication as part of an individual health plan, for example for an on-going condition such as asthma or eczema etc and is for the use of that child only. For staff: Individual health plan sighted and a copy taken: Tick One: Yes No Name of medicine: Method and dose of medicine: When does the medicine need to be taken: (State time or specific symptoms) Parent/Guardian Signature: Date: / /  Enrolment Details: Date of Enrolment: / / Date of Entry: / / Date of Exit: / / Please Note: 20 Hours ECE is for up to six hours per day, up to 20 hours per week and there must be no compulsory fees when a child is receiving 20 Hours ECE funding. Days Enrolled: Monday Tuesday Wednesday Thursday Friday Times Enrolled: Total hours: 20 Hours ECE at this service Total hours: 20 Hours ECE at another service Total hours: Parent/Guardian Signature: Date: / /

  • Food and Beverages No Exhibitor shall sell or distribute food or beverages of any type without the express, written consent of Management and/or Center.

  • Food and Beverage All food and beverages (alcoholic and non alcoholic) which are located at the Hotel (whether opened or unopened), or ordered for future use at the Hotel as of the Closing, including, without limitation, all food and beverages located in the guest rooms, but expressly excluding any alcoholic beverages to the extent the sale or transfer of the same is not permitted under Applicable Law (the “F&B”);

  • No Government Approval You understand that no state or federal authority has reviewed this Investment Agreement or the Note or made any finding relating to the value or fairness of the investment.

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