marketing, labeling, sale, use handling and control, safety, efficacy, reliability, distribution, storage, transport, packaging or manufacturing of Geneva Products that would reasonably be
expected to lead to the denial, limitation, revocation, or rescission of any of the Geneva Regulatory Permits or of any application for marketing approval currently pending before the FDA or such other Geneva Regulatory Agency.
(e) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, Geneva
and its respective directors, officers, employees and, to the knowledge of Geneva, its other agents (while acting in such capacity) are, and since January 1, 2019 have been, in compliance with all Applicable Laws relating to controlled
substances or the manufacturing, distributing, transporting, labeling, packaging, dispensing, using, reporting, storing, disposing, importing, exporting, controlling, wholesaling, brokering or trading of controlled substances, including the federal
Controlled Substances Act (21 U.S.C. §§ 801 et seq.), the regulations promulgated pursuant thereto, and any other similar local, state, or foreign laws (including in each jurisdiction where Epidiolex or Sativex are approved or have ongoing
clinical trials), including all necessary registration, recordkeeping, reporting, security and storage requirements. Since January 1, 2019 to the date hereof, Geneva has not received any correspondence or any other written communication from
any Governmental Authority, including the Drug Enforcement Administration and local, state or foreign regulatory and law enforcement authorities, of potential or actual non-compliance by, or liability of,
Geneva under any Applicable Law relating to controlled substances.
(f) Since January 1, 2019, all reports, documents, claims,
permits and notices required to be filed, maintained or furnished to the FDA or any other Geneva Regulatory Agency by Geneva and its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such
reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete in
all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2019, neither Geneva nor any of its Subsidiaries, nor, to the knowledge of Geneva, any officer, employee, agent or
distributor of Geneva or any of its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Geneva Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDA or
any other Geneva Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Geneva or any of its Subsidiaries, that, at the time such disclosure was made, would reasonably
be expected to provide a basis for the FDA to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other
Geneva Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except
as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, since January 1, 2019, (i) neither Geneva nor any of its Subsidiaries, nor, to the knowledge of Geneva, any officer,
employee, agent or distributor of Geneva or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21
U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Geneva Products are sold or where Geneva has publicly announced an intention to sell a Geneva Product in 2021; and
(ii) neither Geneva nor any of its Subsidiaries, nor, to the knowledge of Geneva, any officer, employee, agent or distributor of Geneva or any of its Subsidiaries, has been excluded from participation in any federal health care program or
convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935 or any similar
program, including any conduct that would constitute non-compliance with the Federal Anti-Kickback Statute, Federal False Claims Act, or their respective state equivalents.
(g) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, as to
each Geneva Product subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law in any foreign jurisdiction in which material
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