BiTE Antibody definition

BiTE Antibody means any bi-specific, single-chain Antibody binding to the [***] of T cells.
BiTE Antibody means any bi-specific, single-chain Antibody that binds to the [***] of T cells and uses or is based upon Micromet’s proprietary platform technology, including any such Antibody so generated pursuant to this Agreement by or on behalf of Micromet, Amgen or any sublicensee under this Agreement. *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 1.13 “BLA” means a Biologics License Application, supplemental Biologics License Application, or similar application filed or to be filed with the FDA, as described in Title 21 of the U.S. Code of Federal Regulations, Part 601, et seq., or a comparable application in jurisdictions outside the United States of America, including a marketing approval application filed or to be filed with the EMA.

Examples of BiTE Antibody in a sentence

  • Following completion of such activities, Micromet will re-submit such BiTE Antibody to the JSC for Lead Candidate nomination in accordance with the terms of this Section 3.2.1.

  • If the JSC does not nominate the proposed BiTE Antibody as a Lead Candidate and the JSC recommends that such BiTE Antibody should be subject to additional work, then the Parties will amend the Development Plan to reflect any desired additional activities and Micromet will use Commercially Reasonable Efforts to conduct such activities.

  • A Bispecific T-Cell Engager (BiTE) Antibody Construct Blinatumomab for the Treatment of Patients With Relapsed/Refractory Non-Hodgkin Lymphoma: Final Results From a Phase I Study.

  • During the Option Period, Micromet will provide Bayer with a quarterly update regarding its activities in respect of the BiTE Antibody binding to the Collaboration Target.

  • The JPT will propose BiTE Antibody candidates for Amgen to review.

  • The Research Plan will be designed to produce BiTE Antibodies that fulfill the required Development Candidate Criteria for selection of at least one (1) such BiTE Antibody as a Development Candidate.

Related to BiTE Antibody

  • 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.

  • 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)).

  • 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 Compound means [***].

  • 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.

  • Antigen means a substance recognized by the body as being foreign; it results in the production of specific antibodies directed against it.

  • 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.

  • Opioid antagonist means a drug that binds to opioid

  • 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”).

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • 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.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • 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.

  • 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:

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Receptor means enclosed spaces, conduits, protected groundwater sources, drinking and non-drinking water wells, surface water bodies, and public water systems which when impacted by chemicals of concern may result in exposure to humans and aquatic life, explosive conditions or other adverse effects on health, safety and the environment as specified in these rules.

  • 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.

  • 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.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • 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.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Biosimilar means a biological product that is highly similar to a specific reference biological

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • 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.