FDA Requirements. Licensee shall, at its sole expense, ensure that the manufacture, marketing and sale of Licensed Product complies with all applicable FDA rules and regulations, including without limitation rules and fees pertaining to marketing eligibility and requirements necessary to maintain the listing for the Licensed Product in the “Orange Book” including, but not limited to, filing NDA Annual Reports and Safety Reports and paying Establishment Fees and Orange Book listing fees, and the Food, Drug and Cosmetic Act as most recently amended.
FDA Requirements. To ensure continued compliance with the U.S. Food and Drug Administration’s (“FDA”) requirements, Purchaser and any DME Distributors to whom Purchaser sells Private Labeled Products shall not, directly or indirectly, supply any Private Labeled Products comprising a PainShield® device to patients without first obtaining an order or prescription from a physician, if applicable FDA rules or regulations so require. Purchaser and any DME Distributors to whom Purchaser sells Private Labeled Products shall be responsible for maintaining records of all such physician prescriptions for orders of Private Labeled Products that include a PainShield® device.
FDA Requirements. Except as set forth on Schedule 4.15, the Company and to the knowledge ------------- of the Company, Celtrix are in compliance in all material respects with all applicable FDA requirements. With respect to any Investigational New Drug Application ("IND") filed by the Company, or to the knowledge of the Company, by --- Celtrix with respect to all drugs currently under development neither the Company nor Celtrix has been advised by the FDA that such IND was or may in the future be (i) terminated, or (ii) subject to indefinite clinical hold, nor is the Company aware of the occurrence of any event that would result in such termination or indefinite clinical hold.
FDA Requirements. I further hereby certify that the Borrower is in compliance with all governmental requirements, rules or regulations applicable to Borrower’s business, including all requirements, rules and regulations imposed on the Borrower by the United States Food and Drug Administration. STAAR SURGICAL COMPANY By: Its Chief Financial Officer Exhibit C to Credit and Security Agreement PREMISES The Premises referred to in the Credit and Security Agreement are legally described as follows: [To be completed by Borrower]
FDA Requirements. The manufacture by any Seller of the TMR Products is being conducted, and to the Knowledge of Sellers the manufacture by any third party contracted by any Seller for the manufacture of such TMR Products is being conducted, in compliance with all applicable Legal Requirements, including the FDA’s current Good Manufacturing Practices (QSR). All complaints about the TMR Products have been timely reviewed, evaluated, and investigated as appropriate, and adequate corrective and preventive action has been or is in the process of being timely implemented, all as required under 21 C.F.R. Sections 820.100, 820.198 and other applicable provisions of the QSR. In addition, each Seller is in compliance with all other applicable FDA requirements, including, but not limited to, registration and listing requirements set forth in 21 U.S.C. Section 460 and 21 C.F.R. Part 207 and all other applicable Legal Requirements. The TMR Products have been commercially distributed by Seller to its distributors in compliance with the conditions of approval set forth by the FDA included in the PMAs. Sellers have complied in all material respects with all such conditions of approval. Sellers have not made any false, misleading, or otherwise inaccurate statements to the FDA or any other Governmental Authority.
FDA Requirements. “FDA Requirements” shall mean all applicable Legal Requirements (including, but not limited to, Section 321 et. seq. of Title 21 of the FDCA) administered or issued by the FDA or any applicable, comparable state or foreign Governmental Table of Contents Body having equivalent authority over medical devices, including requirements related to premarket clearance, exemption from premarket clearance, premarket approval, establishment registration and product listing, medical device reporting, corrections and removals, recalls, import and export requirements, product labeling, promotional materials and advertising, supplier qualification, purchasing controls, product testing, quality system regulation, and good manufacturing practices.
