Breaches under internal review or investigation by the Company in relation to the same. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries comply, and have complied, with all applicable state and federal data privacy and security laws and regulations and industry standards applicable to the performance of Company’s obligations under any contracts regarding the collection, use, storage, retention, disclosure, transfer, disposal, or any other processing (collectively “Process” or “Processing”) and privacy, confidentiality, integrity and security of Personal Data (“Privacy Laws”). To ensure compliance with the Privacy Laws, the Company and its subsidiaries have in place, comply with, and take appropriate steps designed to ensure compliance in all material respects with the Company’s policies and procedures relating to data privacy and security and the collection, storage, use, disclosure, handling, and analysis of Confidential Data (the “Policies”). The Company and its subsidiaries, and, to the knowledge of the Company, any third parties performing operations involving Personal Data on behalf of Company and its subsidiaries, have at all times made all required disclosures to and obtained all necessary consents from the data subjects from whom such Personal Data was and will be collected, except where the failure to make such disclosures or obtain such consents would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. “Personal Data” means all information that relates to an identified or identifiable individual and is regulated as “personal data,” “personal information,” “individually identifiable health information,” “protected health information,” “personally identifiable information,” or any similar information under any Privacy Law.
(z) No Complaints. There has been no complaint, audit, proceeding, investigation, demand or claim made against the Company or its subsidiaries, in respect of the Processing of Personal Data by the Company or its subsidiaries, and, no such complaint, audit, proceeding, investigation or claim is or has been threatened in writing.
(aa) FDA Compliance. Except in each case as would not, whether individually or in the aggregate, reasonable be expected to have a Material Adverse Effect, the Company: (A) is and at all times has been in compliance with all applicable statutes, rules or regulations enforced by the U.S. Food and Drug Administration (“FDA”) and other comparable governmental entities having oversight over the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the FDA or any governmental entity alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all Authorizations, such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (D) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that the FDA or any governmental entity has threatened such action; and (F) has filed, obtained, maintained or submitted all 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
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