“Materials” means any and all physical embodiments of chemical or biological materials.
“Person” means any individual, partnership, limited partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture, governmental entity or other entity or organization.
“Product” means any enzyme replacement therapy, agonist, gene therapy, compound or other pharmaceutical preparation that (a) constitutes ENPP1 or whose primary method of action is to replace ENPP1 or to directly modulate ENPP1 or to directly increase or decrease ENPP1 levels and (b) was researched, developed, manufactured, commercialized or otherwise exploited by or on behalf of Seller prior to the Effective Date. For clarity, Product shall include prodrugs, analogs, salts, free acids, free bases, clathrates, solvates, hydrates, hemihydrates, anhydrides, esters, chelates, conformers, congeners, crystal forms, crystal habits, polymorphs, amorphous solids, homologs, isomers, stereoisomers, enantiomers, racemates, isotopic or radiolabeled equivalents, metabolites and conjugates of any of the above.
“Program” means any program conducted by or on behalf of Seller prior to the Effective Date that was directed to the research, development, manufacture, commercialization or other exploitation any Product.
“Regulatory Authority” means any governmental entity with jurisdiction or authority over the development, manufacture, commercialization or other exploitation of pharmaceutical products, and any corresponding national or regional regulatory authorities.
“Regulatory Submissions” means all filings, applications and submissions with or to any Regulatory Authority in support of the development, manufacture, commercialization or other exploitation of any Product, and all formal and informal, written or electronic correspondence or communications with or from any relevant Regulatory Authority with respect to any Product, as well as minutes of any material meetings, telephone conferences, or discussions with any Regulatory Authority with respect to any Product.
“Representatives” means, with respect to either Party, such Party’s Affiliates and its and their respective employees, directors, officers and managers.
“Seller Permitted Encumbrance” means (a) statutory Encumbrances arising out of operation of law with respect to a Liability incurred in the ordinary course of business and which is not delinquent; (b) Encumbrances for taxes not yet due, payable, delinquent or subject to penalties for nonpayment, or which are being contested in good faith through appropriate proceedings; (c) imperfections of title or encumbrances, if any, that, individually or in the aggregate, do not materially impair, and are not reasonably likely to materially impair, the continued use and operation of the Assets, (d) mechanics’, materialmens’, carriers’, workmens’, warehousemens’, repairmens’, landlords’ or other like Encumbrances and security obligations that are incurred in the ordinary course of business and are not delinquent, and (e) non-exclusive licenses granted by Seller or its Affiliates under any Assets in the ordinary course of business.
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