have entered into a valid and enforceable written contract providing for (i) the assignment (via a present grant of assignment) to Borrower of any and all of such Person’s right, title, and interest in such Intellectual Property, (ii) the non-disclosure by such Person of all confidential information of Borrower, and (iii) the contractual obligation to execute any and all documentation reasonably necessary to implement the obligations of (i) and (ii). To Borrower’s knowledge, no Person has breached in any material respect any such agreement.
(e) Except as set forth on Schedule 5.5(e), no funds or facilities or other resources of any Governmental Authority were used in the development of any Owned Intellectual Property, except for any such funding or use of facilities or resources that does not result (or could not reasonably result) in such Governmental Authority, or employee or staff member thereof, obtaining any rights in any Owned Intellectual Property.
5.6. FDA Matters.
(a) Borrower is, and since January 1, 2019 at all times has been, in compliance in all material respects with the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., and applicable regulations, as amended (collectively, the “FDCA”), including the rules and regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and comparable Laws in any non-U.S. jurisdiction.
(b) As to each product subject to the FDCA or similar Law in any non-U.S. jurisdiction that is developed, manufactured, manufactured for, tested, distributed, and/or marketed by Borrower (a “Borrower Product”), each such Borrower Product is being, and since January 1, 2019 has been, developed, manufactured, manufactured for, labeled, tested, distributed, and/or marketed in material compliance with all applicable requirements under the FDCA and similar laws, including those relating to investigational use, approval, or premarket clearance to market any Borrower Product, current good manufacturing practices, labeling, and Quality System Regulation, as defined in 21 C.F.R. Parts 4, 211, and 820 (as applicable), advertising, promotion, continuing medical education, recordkeeping, training, medical device reporting, adverse event reporting, and filing of other reports and security.
(c) Borrower has not received any communication from FDA or any other Governmental Authority (i) contesting the investigational use of, premarket clearance or approval of, the uses of, or the labeling and promotion of any Borrower Product, or (ii) otherwise alleging any violation of the FDCA or any similar Law as applicable to any Borrower Product.
(d) No Borrower Product (i) is currently under consideration by Borrower for recall, withdrawal, suspension, seizure, or discontinuance, or (ii) has been recalled, subjected to a product advisory notice, withdrawn, suspended, seized, or discontinued (other than for commercial or other business reasons) by Borrower, whether voluntarily or otherwise.
(e) Borrower has not received any communication that the FDA or any similar Governmental Authority (i) intends to withhold or materially condition its approval or clearance of any Borrower Product; (ii) has commenced, or has threatened to initiate, any action to withdraw its approval or clearance of any Borrower Product; (iii) has requested the recall, withdrawal, suspension, seizure, or discontinuance of any Borrower Product; (iv) has commenced, or has threatened to initiate, any action to enjoin the manufacture, sale, or distribution of any Borrower Product or the operations of Borrower; or (v) has commenced, or has threatened to initiate, any criminal action or proceeding against Borrower or any of its respective officers, employees, or agents.
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