Antibody means a molecule comprising or containing one or more immunoglobulin variable domains or any fragments, derivatives, variants or modifications thereof that bind to the same antigen.
Licensed Compound means [***].
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)).
Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.
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.
Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).
Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.
Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.
Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].
Compounds means any or all of the following chemicals, as the context requires:
Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.
Opioid antagonist means a drug that binds to opioid
Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.
Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;
Reference biological product means the single biological product licensed pursuant to 42 U.S.C.
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.
Biosimilar means a biological product that is highly similar to a specific reference biological
Compound means the taking of two or more ingredients and fabricating them into a single
Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).
Antigen means a substance recognized by the body as being foreign; it results in the production of specific antibodies directed against it.
Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).
Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.
Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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.
Therapeutic school means a residential group living facility: