“Personal Data” means any information about or associated with an identified or identifiable natural person that alone or in combination with other information identifies, or could be used to identify, a natural person or household, or that otherwise constitutes “personal data,” “personally identifiable information,” “individually identifiable health information,” “protected health information” or “personal information” under any applicable data privacy Laws; provided that “Personal Data” does not include information that is lawfully available to the public, whether through federal, state or local Governmental Entity records or otherwise.
“Processing,” “Process,” or “Processed” means any collection, access, acquisition, storage, protection, use, recording, maintenance, operation, dissemination, re-use, disposal, disclosure, re-disclosure, deletion, destruction, sale, transfer, modification, or any other processing (as defined by applicable data privacy Laws) of Personal Data.
“Registrations” means any authorizations, approvals, clearances, consents, licenses, permits, certificates, exemptions, or registrations issued or otherwise granted by any Regulatory Authority (including 510(k) pre-market notification clearances, de novo classifications, pre-market approvals, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, CE Marks, pricing and reimbursement approvals, labeling approvals, registration notifications, or their foreign equivalent), in each case, that are required for the research, development, production, manufacture, labeling, distribution, marketing, storage, shipping, transportation, export, import, use, or sale of Company Products.
“Regulatory Authority” means the FDA and any other Governmental Entity of competent jurisdiction that regulates the research, development, production, manufacture, labeling, distribution, marketing, storage, shipping, transportation, export, import, use, or sale of Company Products, including any Notified Body.
“Release” means any presence emission, spill, seepage, leak, escape, leaching, discharge, injection, pumping, pouring, emptying, dumping, disposal, migration, threatened release or release of Hazardous Substances from any source into, through or upon the indoor or outdoor environment.
“Sanctioned Country” means a country or territory that is, at the applicable time of determination, itself the subject or target of comprehensive Sanctions.
“Sanctioned Person” means any Person that is, at the applicable time of determination, the target of Sanctions, including, at the applicable time of determination, (i) any Person listed in any Sanctions-related list of designated Persons maintained by OFAC or the U.S. Department of State, the United Nations Security Council, the European Union, His Majesty’s Treasury of the United Kingdom, the European Union or its Member States, (ii) any Person ordinarily located, organized or ordinarily resident in a Sanctioned Country, or (iii) any Person 50% or more owned or otherwise controlled by any such Person or Persons described in the foregoing clauses (i) and (ii).
“Sanctions” means economic or financial sanctions or trade embargoes imposed, administered or enforced from time to time by the U.S. Government through OFAC, the Bureau of Industry and Security of the U.S. Department of Commerce, and the U.S. Department of State, the United Nations Security Council, the European Union and its Member States, His Majesty’s Treasury, or any other similar Governmental Entity.
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