(x) Regulatory Filings. Except as disclosed in the Registration Statement, the Time
of Sale Prospectus and the Prospectuses, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authorities (including, without limitation, the FDA, or any foreign, federal, state, provincial or local
Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a
Material Adverse Effect; except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectuses, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable laws
when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the
aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the
FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Registration Statement, the Time of Sale Prospectus and
Prospectuses the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Prospectus and the Prospectuses.
(y) Intellectual Property. Except as disclosed in the Registration Statement, the Time of Sale Prospectus, and the Prospectuses, the
Company and its Subsidiaries own, possess, license or have other rights to use all foreign and domestic patents, patent applications, trade and service marks, trade and service mark registrations, trade names, copyrights, licenses, inventions, trade
secrets, technology, Internet domain names, know-how and other intellectual property (collectively, the Intellectual Property), necessary for the conduct of their respective businesses as
now conducted except to the extent that the failure to own, possess, license or otherwise hold adequate rights to use such Intellectual Property would not, individually or in the aggregate, have a Material Adverse Effect. Except as disclosed in the
Registration Statement¸ the Time of Sale Prospectus and the Prospectuses, and except as pursuant to the Credit Agreement, (i) there are no rights of third parties to any such Intellectual Property owned by the Company and its
Subsidiaries; (ii) to the Companys knowledge, there is no infringement by third parties of any such Intellectual Property; (iii) there is no pending or, to the Companys knowledge, threatened action, suit, proceeding or claim by
others challenging the Companys and its Subsidiaries rights in or to any such Intellectual Property, and the Company is unaware of any facts which could form a reasonable basis for any such action, suit, proceeding or claim;
(iv) there is no pending or, to the Companys knowledge, threatened action, suit, proceeding or claim by others challenging the validity or scope of any such Intellectual Property; (v) there is no pending or, to the Companys
knowledge, threatened action, suit, proceeding or claim by others that the Company and its Subsidiaries infringe or otherwise violate any patent, trademark, copyright, trade secret or other proprietary rights of others; (vi) to the
Companys knowledge, there is no third-party U.S. patent or published U.S. patent application which contains claims for which an Interference Proceeding (as defined in 35 U.S.C. § 135 (pre-AIA))
has been commenced against any patent or patent application described in the Registration Statement¸ the Time of Sale Prospectus and the Prospectuses as being owned by or licensed to the Company; and (vii) the Company and its Subsidiaries
have complied with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or such Subsidiary, and, to the Companys knowledge, all such agreements are in full force and effect, except, in the case
of any of clauses (i)-(vii) above, for any such infringement by third parties or any such pending or threatened suit, action, proceeding or claim as would not, individually or in the aggregate, result in a Material Adverse Effect.
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