FDCA Compliance Sample Clauses

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.

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.