Department of Health and Human Services Uses in Legal Requirements Clause

Legal Requirements from Asset Purchase Agreement

This ASSET PURCHASE AGREEMENT (this Agreement) is made and entered into as of May 22, 2015 (the Effective Date), by and between SANOFI (Buyer) and RETROPHIN, INC. (Seller). Buyer and Seller may hereinafter be referred to individually as a Party and collectively as the Parties.

Legal Requirements. means any federal, state, foreign, local, municipal or other law, statute, constitution, principle of common law, resolution, ordinance, code, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity and any Orders applicable to a Party or to any of its assets, properties or businesses. Legal Requirements shall include, with respect to Seller, any responsibilities, requirements, parameters and conditions relating to the Priority Review Voucher set forth in the NDA 205750 approval letter from the Department of Health and Human Services to Asklepion, Reference ID 3720341, regarding approval of the Subject NDA.

Legal Requirements from Asset Purchase Agreement

This ASSET PURCHASE AGREEMENT (this Agreement) is made and entered into as of July 29, 2014, by and between Regeneron Ireland (Buyer), BioMarin Pharmaceutical Inc. (BPI), and BioMarin GALNS Ltd. (Seller). Buyer, BPI, and Seller may hereinafter be referred to individually as a Party and collectively as the Parties.

Legal Requirements. means any federal, state, foreign, local, municipal or other law, statute, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity and any orders, writs, injunctions, awards, judgments and decrees applicable to a Party or to any of its assets, properties or businesses. Legal Requirements shall include, with respect to BPI and Seller, any requirements relating to the Priority Review Voucher set forth in the letter from the Department of Health and Human Services to BPI, Reference ID 3454769, regarding the BLA approval for Vimzim (elosulfase alfa).