MSD Compound definition

MSD Compound means pembrolizumab, a humanized anti-human PD-1 monoclonal antibody, [***].
MSD Compound means pembrolizumab, a humanized anti-human PD-1 monoclonal antibody,.
MSD Compound means pembrolizumab, a humanized anti-human PD-1 monoclonal antibody, [***]. 1.47. “MSD Inventions” has the meaning set forth in Section 10.3. 1.48. “NDA” means a New Drug Application, Biologics License Application, Premarket Approval Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical, medical device or diagnostic product in that country or in that group of countries. 1.49. “Non-Conformance” means, with respect to a given unit of the MSD Compound or the Novocure Device (a) an event that deviates from a requirement (an approved cGMP requirement with respect to the MSD Compound), such as a procedure, Specification, or operating parameter, or that requires an investigation to assess impact to the quality of the MSD Compound or the Novocure Device or (b) that such MSD Compound for such Novocure Device failed to meet the applicable representations and warranties set forth in Section 2.3. For the MSD Compound, classification of the Non-Conformance is detailed in the Clinical Quality Agreement. 1.50. “Non-Filing Party” has the meaning set forth in Section 10.1.1(c). 1.51. “Novocure” has the meaning set forth in the preamble. 1.52. “Novocure Background Patents” has the meaning set forth in Section 10.4.1. 1.53. “Novocure Device” means the medical device identified in the Protocol for providing low intensity, intermediate frequency, alternating electric fields (Tumor Treating Fields) delivered through noninvasive transducer arrays placed locoregionally to target tumors.

Examples of MSD Compound in a sentence

  • Collaborator shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the MSD Compound, and in particular shall not analyze the MSD Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreement.

  • Collaborator shall: (i) use the MSD Compound solely for purposes of performing the MSD Compound Study; and (ii) not use the MSD Compound in any manner that is inconsistent with this Agreement or for any commercial purpose.

  • Upon request, Collaborator shall provide MSD with a certificate of analysis covering each shipment of Collaborator Compound used in the MSD Compound Study.

  • The Parties’ obligations with respect to the labeling and packaging of the MSD Compound are as set forth in the Clinical Quality Agreement.

  • Collaborator shall prepare the patient informed-consent form for the MSD Compound Study (which shall include provisions regarding the use of Samples in Sample Testing) in consultation with MSD (it being understood and agreed that the portion of the informed- consent form relating to the Sample Testing of the MSD Compound shall be provided to Collaborator by MSD and adopted by Collaborator).

  • If either Party determines in good faith that the MSD Compound Study or Collaborator Clinical Trial may unreasonably adversely affect patient safety, such Party shall promptly notify the other Party of such determination.

  • A certificate of analysis shall accompany each shipment of the MSD Compound to Collaborator.

  • Promptly following MSD Compound Study Completion, Collaborator shall provide to MSD an electronic draft of the [***]and an electronic draft of the [***].

  • The proposal must not adversely affect the functioning or appearance of the units and shopping centre or surrounding residential amenity.

  • The sole and exclusive remedies of Collaborator with respect to any MSD Compound that is found to be Non-Conforming at the time of Delivery shall be: [***].

Related to MSD Compound

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Licensed Compounds means any EZH2 Compound(s) that is:

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

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any other aptamer product used for Diagnosis. For purposes of clarity, the term Diagnostic Product shall not include a product used for the delay of onset or progression of, or treatment or prevention of, an Indication.

  • 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.

  • Compounds means a small molecule HMT inhibitor.

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

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • 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.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

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

  • 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.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Combination Product means a product that includes a device for delivery or at least one active ingredient other than a Licensed Product.

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