substantially all of Seller’s assets (whether through a stock purchase, merger, sale of all or substantially all assets or otherwise) so long as such acquisition provides that this Agreement continues to be binding, enforceable and in full force and effect on the same terms in effect as of the Effective Date.
(e) “Approval Letters” means, collectively, the letter, dated September 29, 2021, and the corrected letter, dated October 20, 2021, from the FDA to Seller, issuing the FDA Approval and granting the Priority Review Voucher, attached hereto as Exhibit A.
(f) “Asset Purchase” has the meaning set forth in the Recitals.
(g) “Business Day” means a day (i) other than Saturday or Sunday and (ii) on which commercial banks are open for business in New York, New York, United States.
(h) “Confidential Disclosure Agreement” means that certain Confidential Disclosure Agreement by and between the Parties (including their Affiliates), dated November 2, 2021.
(i) “Consent” means any and all filings, authorizations, consents, approvals, notices, permits, orders, registrations or declarations.
(j) “Contract” means any written or oral legally binding contract, agreement, instrument, commitment or undertaking (including leases, licenses, mortgages, notes, guarantees, sublicenses, subcontracts and purchase orders).
(k) “DOJ” means the United States Department of Justice.
(l) “Encumbrance” means any lien, pledge, charge, mortgage, owner’s mortgage, easement, encroachment, imperfection of title, title exception, title defect, right of possession, right of negotiation or refusal, leasehold interest, security interest, encumbrance, adverse claim, interference, or other restriction on transfer, ownership or use.
(m) “FDA” means the U.S. Food and Drug Administration.
(n) “FDA Approval” means the commercial marketing authorization issued by the FDA to Seller relating to NDA 214662 for Livmarli (maralixibat) oral solution in accordance with Section 505(b)(1) of the FFDCA on September 29, 2021.
(o) “FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
(p) “FTC” means the United States Federal Trade Commission.
(q) “Fundamental Representations” means the representations and warranties contained in Section 3.1 (Organization; Standing and Power), Section 3.2 (Due Authority), Section 3.3(b)(i) (No Contravention), Section 3.5 (Title to Purchased Assets), Section 3.11 (Revocation; Use of Purchased Assets), Section 3.12 (Marketed Product) and Section 3.13 (Brokers).
(r) “Governmental Entity” means any supranational, national, state, municipal, local or foreign government, any court, tribunal, arbitrator, administrative agency, commission or other governmental official, authority or instrumentality, in each case whether domestic or foreign, any stock exchange or similar self-regulatory organization or any quasi-governmental, private body or arbitral body exercising any executive, legislative, judicial, quasi-judicial, regulatory, taxing, administrative or other governmental or quasi-governmental authority.
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