(oo) Compliance with Laws. The Company has not been advised, and has no reason to
believe, that it and each Subsidiary is not conducting business in compliance with all applicable laws, rules and regulations of the jurisdictions in which it is conducting business, except where failure to be so in compliance would not reasonably
be expected to result in a Material Adverse Change. The Company and each Subsidiary: (i) is and at all times has been in compliance with all statutes, rules, or regulations applicable to the ownership, testing, development, manufacture,
packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company or any Subsidiary (Applicable
Laws), except as would not reasonably be expected to result in a Material Adverse Change; (ii) has not received any unresolved Form FDA 483, notice of adverse finding, warning letter, untitled letter or other written
correspondence or written notice from the FDA or any other governmental authority alleging or asserting noncompliance in any material respect with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and
supplements or amendments thereto required by any such Applicable Laws (Authorizations); (iii) possesses all material Authorizations and such Authorizations are valid and in full force and effect and are not in material
violation of any term of any such Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority or third party
alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and has no knowledge that any such governmental authority or third party is considering any such claim, litigation, arbitration, action, suit,
investigation or proceeding; (v) has not received written notice that any governmental authority has taken, is taking or intends to take action to materially and adversely limit, suspend, or revoke any Authorizations and has no knowledge that
any such governmental authority is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required
by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were
corrected or supplemented by a subsequent submission); and (vii) has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety
alert, dear healthcare provider letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Companys knowledge, no third party has
initiated, conducted or intends to initiate any such written notice or action.
(pp) Privacy Laws. The Company and its Subsidiaries
are, and at all prior times were, in material compliance with all applicable data privacy and security laws and regulations, including, without limitation, to the extent applicable, if any, the Health Insurance Portability and Accountability Act
(HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act (the HITECH Act) (42 U.S.C. Section 17921 et seq.); and the Company and its Subsidiaries have
taken all necessary actions to comply in all material respects with the European Union General Data Protection Regulation (GDPR) (EU 2016/679) (collectively, Privacy Laws). To ensure compliance
with the Privacy Laws, the Company and its Subsidiaries have in place, comply with, and take appropriate steps reasonably designed to ensure compliance in all material respects with their policies and procedures relating to data privacy and security
and the collection, storage, use, disclosure, handling and analysis of Personal Data (the Policies). The Company provides accurate notice of its Policies to its customers, employees, third party vendors and representatives,
as applicable. The Policies provide accurate and sufficient notice of the Companys then-current privacy practices relating to its subject matter and such Policies do not contain any material omissions of the Companys then-current privacy
practices. Personal Data means: (i) a natural persons name, street address, telephone number, email address, photograph, social security number, bank information, or customer or account number; (ii) any
information which would qualify as personally identifying information under the Federal Trade Commission Act, as amended; (iii) Protected Health Information as defined by HIPAA; (iv) personal data as defined by GDPR; and
(v) any other piece of information that allows the identification of such natural person, or his or her family, or permits the collection or analysis of any data related to an identified persons health or sexual orientation. None of such
disclosures made or contained in any of the Policies have been inaccurate, misleading, deceptive or in violation of any Privacy Laws or Policies in any material respect. The execution, delivery and performance of this Agreement or any other
agreement referred to in this Agreement will not result in a material breach of any Privacy Laws or Policies. Neither the Company nor any Subsidiary: (y) has received notice of any actual or potential liability under or relating to, or actual
or potential violation of, any of the Privacy Laws, and has no knowledge of any event or condition that would reasonably be expected to result in any such notice; or (z) is a party to any order, decree, or agreement that imposed any obligation
or liability under any Privacy Law.
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