| Product is being manufactured, packaged, labeled, tested, distributed, sold and/or
marketed by the Company in compliance with all applicable requirements under FDCA
and similar laws, rules and regulations relating to registration, investigational use,
premarket clearance, licensure, or application approval, good manufacturing practices,
good laboratory practices, good clinical practices, product listing, quotas, labeling,
advertising, record keeping and filing of reports, except where the failure to be in
compliance would not have a Material Adverse Effect. There is no pending, completed
or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or
legal or administrative or regulatory proceeding, charge, complaint, or investigation)
against the Company or any of its Subsidiaries, and none of the Company or any of its
Subsidiaries has received any notice, warning letter or other communication from the
FDA or any other governmental entity, which (i) contests the premarket clearance,
licensure, registration, or approval of, the uses of, the distribution of, the manufacturing
or packaging of, the testing of, the sale of, or the labeling and promotion of any
Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or
seizure of, or withdraws or orders the withdrawal of advertising or sales promotional
materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any
clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production
at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter
into a consent decree of permanent injunction with the Company or any of its
Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by
the Company or any of its Subsidiaries, and which, either individually or in the
aggregate, would have a Material Adverse Effect. The properties, business and operations
of the Company have been and are being conducted in all material respects in accordance
with all applicable laws, rules and regulations of the FDA. The Company has not been
informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the
United States of any product proposed to be developed, produced or marketed by the
Company nor has the FDA expressed any concern as to approving or clearing for marketing
any product being developed or proposed to be developed by the Company.
(ii) Cybersecurity. (i)(x) There has been no security breach or other
compromise of or relating to any of the Company’s or any Subsidiary’s information
technology and computer systems, networks, hardware, software, data (including the data
of its respective customers, employees, suppliers, vendors and any third party data
maintained by or on behalf of it), equipment or technology (collectively, “IT Systems and
Data”) and (y) the Company and the Subsidiaries have not been notified of, and have no
knowledge of any event or condition that would reasonably be expected to result in, any
security breach or other compromise to its IT Systems and Data; (ii) the Company and
the Subsidiaries are presently in compliance with all applicable laws or statutes and all
judgments, orders, rules and regulations of any court or arbitrator or governmental or
regulatory authority, internal policies and contractual obligations relating to the privacy
and security of IT Systems and Data and to the protection of such IT Systems and Data
from unauthorized use, access, misappropriation or modification, except as would not,
individually or in the aggregate, have a Material Adverse Effect; (iii) the Company and
the Subsidiaries have implemented and maintained commercially reasonable safeguards
to maintain and protect its material confidential information and the integrity, continuous
operation, redundancy and security of all IT Systems and Data; and (iv) the Company and |