announcement or pendency of this Agreement or the Transactions; or (iii) changes after the Agreement Date in the market price or trading volume of the Common Shares or the credit rating of
the Company (it being understood that matters underlying the changes described in this clause (iii) may, to the extent not in contravention of the forgoing subclause (a), be deemed to constitute, or be taken into account, in determining whether
there has been an Intervening Event).
Investigator means a Person (a) as defined in 21 C.F.R, 312.3(b) or
(b) as defined under any similar definition under the Laws of other applicable jurisdictions, and in each case, includes all Persons identified as Investigator, Principal Investigator,
Sub-Investigator or, a Sponsor-Investigator.
IRB means
any national, central, local or regional institutional review board or ethics committee of any applicable jurisdiction designated to review, approve or monitor the conduct of clinical research, with the aim to protect the rights, welfare and safety
of human subjects, including any such entity as described in 21 C.F.R. Part 56, or foreign equivalent of the foregoing.
IRS means the U.S. Internal Revenue Service.
Judgment means any order, decision, ruling, charge, writ, judgment, injunction, decree, stipulation, determination, award,
settlement agreement, corporate integrity agreement, arbitration ruling, deferred prosecution agreement, subpoena, civil investigative demand, verdict, assessment or agreement issued, promulgated or entered by or with any Governmental Entity.
The Knowledge of any Person that is not an individual means, with respect to any matter in question, in the case of the
Knowledge of the Company, the actual knowledge of the executive officers of the Company or Company Subsidiaries set forth on Schedule A, and, in the case of Parent and Merger Sub, the actual knowledge of the executive officers of Parent set
forth on Schedule B.
Law means any national, supranational, EU, state, provincial, municipal or local statute,
law, resolution, constitution, treaty, ordinance, code, regulation, statute, rule, notice, regulatory requirement, interpretation, agency guidance, Judgment, stipulation, determination, certification standard, accreditation standard, Permit,
requirement or rule of law (including common law), code or edict issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity, including Health Care Laws.
Leased Real Property means each parcel of real property currently leased, subleased, or licensed by the Company or any
Company Subsidiary.
Liabilities means any and all liabilities, obligations and Indebtedness, whether accrued or fixed,
absolute or contingent, matured or unmatured or determined or undeterminable, on- or off-balance sheet or required to be recorded on a balance sheet prepared in
accordance with GAAP, including those arising under any Law, those arising under any Contract, or otherwise.
Lien
means, with respect to any property or asset, any lien, pledge, hypothecation, claim, mortgage, security interest or encumbrance in respect of such property or asset.
Made Available means that the referenced documents or other information and materials were made available to Parent or its
Representatives prior 8:00 a.m. Pacific Time on November 10, 2020 in (i) the electronic data room established for Parents due diligence in connection with the Transactions, or (ii) through electronic mail.
Marketing Approval means collectively, all approvals of an applicable Governmental Entity as necessary to allow for the
marketing and sale of a product in the country concerned, including, as applicable, an approved BLA or NDA Approval.
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