Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.
Compounds means any or all of the following chemicals, as the context requires:
genocide means any of the following acts committed with intent to destroy, in whole or in part, a national, ethnical, racial or religious group, as such:
Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).
Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.
Commercialize or “Commercialization” means the marketing, promotion, sale (and offer for sale or contract to sell), distribution, importation or other commercial exploitation (including pricing and reimbursement activities) for a Product in the Territory. Commercialization shall include commercial activities conducted in preparation for Product launch.
Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.
Licensed Compounds means any EZH2 Compound(s) that is:
Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.
Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.
Gene Therapy means a product or service for the treatment or prevention of a disease that utilizes ex vivo or in vivo delivery (via viral or nonviral gene transfer methods or systems) of Genetic Material, including any cell incorporating Genetic Material.
Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.
Corrosion inhibitor means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.
Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.
Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].
Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed, or the form of pesticide as purchased by users;
Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.
Licensed Compound means [***].
Research Program has the meaning set forth in Section 2.1.
Cell Line means the cell line, particulars of which are set out in Schedule 1.
Genetic material means any material of plant, animal, microbial or other origin containing functional units of heredity.
Program Technology means Program Know-How and Program Patents.
Manufacturing Process means any process for—
Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.
Commercialized shall have corresponding meanings.
Collaboration has the meaning set forth in Section 2.1.