BioLineRx Compound definition

BioLineRx Compound means BioLineRx’s BL-8040, a short synthetic peptide, which is a CXCR4 inhibitor.
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BioLineRx Compound means BL-8040, a C-X-C chemokine receptor type 4 antagonist, and any formulations thereof.
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Examples of BioLineRx Compound in a sentence

  • This Agreement does not create any obligation on the part of Merck to provide the Merck Compound for any activities other than the Study, nor does it create any obligation on the part of BioLineRx to provide the BioLineRx Compound for any activities other than the Study, except as expressly set forth in Section 3.14.

  • BioLineRx is developing the BioLineRx Compound (as defined below) for the treatment of certain tumor types.

  • BioLineRx shall, within the time defined in the Clinical Quality Agreement, perform (i) with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement, and (ii) with respect to the BioLineRx Compound, the testing and release procedures allocated to it under the Clinical Quality Agreement.

  • BioLineRx shall replace any BioLineRx Compound for use in the Study as is found to have a Non-Conformance (with respect to BioLineRx Compound that has not yet been administered in the course of performing the Study).

  • For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

  • BioLineRx shall be solely responsible for taking all steps necessary to determine that Merck Compound or BioLineRx Compound, as applicable, is suitable for release before making such Merck Compound or BioLineRx Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by BioLineRx in connection with such determination with respect to the Merck Compound.

  • For the avoidance of doubt, BioLineRx shall be free to use/share (including publish) data and results from the Study, including Clinical Data, which are solely related to the single-agent use of the BioLineRx Compound and are not related to the Combination, and which have been generated during the treatment period in which the BioLineRx Compound is used in monotherapy.

  • BioLineRx shall act as the sponsor of the Study under a new solid tumors IND for the BioLineRx Compound with a Right of Reference to the IND of the Merck Compound as further described in Section 3.4; provided, however, that in no event shall BioLineRx file an additional IND for the Study unless required by Regulatory Authorities to do so.

  • The Pharmacovigilance Agreement will include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, pregnancy reports, and any other safety information arising from or related to the use of the Merck Compound and BioLineRx Compound in the Study, consistent with Applicable Law.

  • BioLineRx shall Manufacture and supply the BioLineRx Compound for purposes of the Study in accordance with Article 8, and BioLineRx hereby represents and warrants to Merck that, at the time of Delivery of the BioLineRx Compound, such BioLineRx Compound shall have been Manufactured and supplied in compliance with: (i) the Specifications for the BioLineRx Compound; (ii) the Clinical Quality Agreement; and (iii) all Applicable Law, including cGMP and health, safety and environmental protections.

Related to BioLineRx Compound

  • Licensed Compound means [***].

  • 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.

  • 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)).

  • 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”).

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

  • 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.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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.

  • 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.

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

  • GSK has the meaning set forth in the preamble.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Exempt compound means the same as defined in Rule 2.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • 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 [***].

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • 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.

  • 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.

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • Novartis shall have the meaning set forth in the Preamble.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Merck has the meaning set forth in the preamble.

  • Compounds means any or all of the following chemicals, as the context requires: