FDCA COMPLIANCE Clause Samples

The FDCA Compliance clause requires parties to adhere to the standards and regulations set forth by the Federal Food, Drug, and Cosmetic Act (FDCA). This means that any products, services, or activities covered by the agreement must comply with applicable FDA rules regarding safety, labeling, manufacturing, and distribution. For example, a manufacturer must ensure that its products are properly labeled and approved before sale. The core function of this clause is to ensure legal compliance and minimize the risk of regulatory violations, thereby protecting both parties from potential penalties or enforcement actions.
POPULAR SAMPLE Copied 1 times
FDCA COMPLIANCE. Buyer and Seller presently believe this Agreement does not relate to the purchase of any food, drug, cosmetic or device, or substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, drug, cosmetic or device (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding any food, drug, cosmetic or device). However, if Seller and Buyer agree upon the use of one of Seller's Material(s) for this type of application, Seller shall guarantee that the thing or things comprising each shipment or other delivery hereafter made by Seller to Buyer, as of the date of such shipment or delivery, is not adulterated or misbranded within the meaning of the U.S. Federal Food, Drug and Cosmetic Act, as amended, or within the meaning of applicable U.S. State laws or Municipal ordinances in which the definitions of adulteration and misbranding are substantially the same as those contained in the U.S. Act, and not an article which may not, under the provisions of Section 404 or 505 of the U.S. Act, be introduced into interstate commerce; is of a suitable grade and complies with all requirements of the Food and Drugs Act of Canada and the Regulations made thereunder, and with the Canadian Federal, Provincial and Municipal laws in that regard; and, that if any such article is a coal-tar color or contains a *CONFIDENTIAL TREATMENT REQUESTED coal-tar color, that said color was manufactured by Seller, and is from a batch certified in accordance with the applicable regulations promulgated under the U.S. Federal Food, Drug and Cosmetic Act, as amended, and Regulations issued under the Food & Drug Act of Canada, as amended, or that Seller has in its possession a guaranty to the same effect from the manufacturer of said color. Seller agrees to indemnify and save harmless Buyer from any claim or action howsoever arising from Seller's failure to comply with the terms of this paragraph.
View Source
FDCA COMPLIANCE. With respect to the conduct or operation of the Business or use of the Purchased Assets, (i) the OrthoRecon Products and product candidates are and have been, since January 1, 2008, developed, manufactured, tested, distributed, promoted and marketed in material compliance with all applicable requirements under the FDCA and comparable Laws in any non-U.S. jurisdiction, including those relating to investigational use, premarket clearance or approval, registration and listing, good manufacturing practices, good clinical practices, good laboratory practices, labeling, advertising, record keeping and filing of required reports, (ii) Seller and each of its Subsidiaries have maintained, since January 1, 2008, materially accurate and complete documentation showing that components supplied to and accepted by Seller and each of its Subsidiaries are manufactured in accordance with Seller’s or its Subsidiaries’ specifications therefor, (iii) the processes used to produce the OrthoRecon Products are described in documents maintained by Seller and each of its Subsidiaries in a materially complete and accurate manner, and such documents have been made available to Purchaser and (iv) such processes are adequate to ensure that commercial quantities of the OrthoRecon Products conform to the specifications established therefor and will not be adulterated or misbranded under the FDCA, in each case in all material respects.
View Source

Related to FDCA COMPLIANCE

  • CEQA Compliance The District has complied with all assessment requirements imposed upon it by the California Environmental Quality Act (Public Resource Code Section 21000 et seq. (“CEQA”) in connection with the Project, and no further environmental review of the Project is necessary pursuant to CEQA before the construction of the Project may commence.

  • OSHA Compliance To the extent applicable to the services to be performed under this Agreement, Contractor represents and warrants, that all articles and services furnished under this Agreement meet or exceed the safety standards established and promulgated under the Federal Occupational Safety and Health Law (Public Law 91-596) and its regulations in effect or proposed as of the date of this Agreement.

  • FCPA Compliance The Company has not and, to the Company’s actual knowledge, none of its employees or agents at any time during the last five years have (i) made any unlawful contribution to any candidate for foreign office, or failed to disclose fully any contribution in violation of law, or (ii) made any payment to any federal or state governmental officer or official, or other person charged with similar public or quasi-public duties, other than payments required or permitted by the laws of the United States or any jurisdiction thereof.

  • FERPA Compliance In connection with all FERPA Records that Contractor may create, receive or maintain on behalf of University pursuant to the Underlying Agreement, Contractor is designated as a University Official with a legitimate educational interest in and with respect to such FERPA Records, only to the extent to which Contractor (a) is required to create, receive or maintain FERPA Records to carry out the Underlying Agreement, and (b) understands and agrees to all of the following terms and conditions without reservation:

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).