Person means an individual, corporation, limited liability company,
partnership, joint venture, association, trust, unincorporated organization or any other entity, including a Governmental Authority.
PHSA means the United States Public Health Service Act, and FDAs implementing regulations.
PII means any (i) any information that identifies, relates to, describes, is reasonably capable of being associated
with, or could reasonably be linked, directly or indirectly, with a particular individual, household, or device (including any patient medical records), and (ii) any other information defined as personal data, personally
identifiable information, individually identifiable health information, personal information, or a similar term under applicable Law.
Regulatory Authorizations means authorizations (i) under the FDCA or the PHSA, including premarket notifications,
premarket authorizations and investigational device exemptions under the FDCA, and (ii) of any applicable Company Regulatory Agency necessary for the lawful operation of the businesses of Company.
Release means any release, spill, emission, leaking, pumping, pouring, emitting, emptying, discharging, injecting,
escaping, leaching, dumping, disposing or migrating into or through the environment.
Representatives means, with
respect to any Person, its and its Subsidiaries and Affiliates directors, officers, employees, consultants, agents, financial advisors, investment bankers, attorneys, accountants, other advisors, and other representatives (acting in such
capacity) retained by or acting on behalf of such Person.
Sanctioned Country means any country or region that is or
has in the past five years been the subject or target of a comprehensive embargo under Sanctions Laws (including Cuba, Iran, North Korea, Venezuela, Sudan, Syria, and the Crimea region).
Sanctioned Person means any individual or entity that is the subject or target of sanctions or restrictions under Sanctions
Laws or Ex-Im Laws, including: (i) any Person listed on any U.S. or non-U.S. sanctions- or export-related restricted or prohibited party list, including OFACs
Specially Designated Nationals and Blocked Persons List, OFACs Sectoral Sanctions Identification List, the U.S. Department of Commerces Denied Persons, Entity and Unverified Lists, the EU Consolidated List, the UN Security Council
Consolidated List, and Her Majestys Treasurys Consolidated List of Financial Sanctions Targets; (ii) any Person that is, in the aggregate, 50 percent or greater owned, directly or indirectly, or otherwise controlled by a Person
or Persons described in clause (i); or (iii) any national of a Sanctioned Country.
Sanctions Laws means all U.S.
and non-U.S. Laws relating to economic or trade sanctions, including the Laws administered or enforced by the U.S. Department of the Treasury, Office of Foreign Assets Control (OFAC), the
U.S. Department of State, the United Nations Security Council, the European Union, or the United Kingdom.
Security
Incident means any incident in which PII in the Companys control, or the Companys confidential information was accessed, disclosed, destroyed, processed, used, or exfiltrated in an unauthorized manner.
Subsidiary, when used with respect to any Person, means any corporation, limited liability company, partnership,
association, trust or other entity of which securities or other ownership interests representing more than 50% of the ordinary voting power (or, in the case of a partnership, more than 50% of the general partnership interests) are, as of such date,
owned by such Person or one or more Subsidiaries of such Person or by such Person and one or more Subsidiaries of such Person.
Tax means any and all U.S. federal, state, local or non-U.S. (including provincial
and territorial) taxes, fees, levies, duties, tariffs, imposts, and other similar charges in the nature of a tax imposed by any
A-56