(E) all other local, state, federal, national, supranational and foreign laws, rules, regulations and policies, relating to the regulation of the Maravai Parties or any of their respective subsidiaries and the ownership, testing, development, manufacture, registration, investigational use, premarket clearance, licensure, application approval, packaging, processing, use, distribution, marketing, labeling, promotion, advertising, sale, offer for sale, storage, import, export or disposal of any product, or product under development, manufactured or distributed by the Maravai Parties or any of their respective subsidiaries; (clauses (A) through (E), collectively, “Applicable Laws”);
and (ii) has not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any Regulatory Authority, governmental authority, court or arbitrator alleging or asserting non-compliance with (x) any Applicable Laws or (y) any certificates, authorizations and permits required by any such Applicable Laws, except in each of cases (i) and (ii) where such noncompliance would not, singly or in the aggregate, have a material adverse effect on the Maravai Parties and their respective subsidiaries, taken as a whole.
(cc) There are no material U.S. Food and Drug Administration (FDA) rules or regulations or other statutes, rules, regulations or policies that are applicable to the businesses of the Maravai Parties or their respective subsidiaries which are not described in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the statements included or incorporated by reference in the Registration Statement, the Time of Sale Prospectus and the Prospectus under the caption: “Government Regulation” are true and correct in all material respects.
(dd) No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act) included or incorporated by reference in any of the Registration Statement, the Time of Sale Prospectus or the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith. Nothing has come to the attention of the Company that has caused the Company to believe that the statistical and market-related data included or incorporated by reference in each of the Registration Statement, the Time of Sale Prospectus and the Prospectus is not based on or derived from sources that are reliable and accurate in all material respects.
(ee) Each employee benefit plan, within the meaning of Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), that is sponsored, maintained, administered or contributed to by the Maravai Parties or any of their respective subsidiaries has been maintained in compliance with its terms and the requirements of any applicable statutes, orders, rules and regulations, including but not limited to ERISA and the Internal Revenue Code of 1986, as amended (the “Code”), and (ii) none of the Maravai Parties, any of their respective subsidiaries nor any member of their respective “Controlled Groups” (defined as any trade or business, whether or not incorporated, that would be
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