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

  • In addition, the Collaborator Clinical Trial may (or may not) have a Collaborator Compound Arm(s), an MSD Compound Arm(s), or both.

  • Collaborator Clinical Trial, Collaborator Compound Arm(s), Combination Arm(s), MSD Compound Arm(s) and MSD Compound Study all refer to such arms as are intended to be conducted in accordance with the Protocol, including the Protocol as may be amended in accordance with Article 4 (PROTOCOL AND INFORMED CONSENT; CERTAIN COVENANTS).

  • Collaborator will transmit to MSD all SAEs from the MSD Compound Study as set forth below.

  • Without prejudice to Section 2.9 (Subsequent Study), this Agreement does not create any obligation for either Party to provide any compound other than its Compound or to provide its Compound for any activities other than the MSD Compound Study.

  • Neither Party shall offer compensation on behalf of the other Party to any MSD Compound Study subject or bind the other Party to any indemnification obligations in favor of any MSD Compound Study subject.

  • Dress Code:The School Dress Code is designed to establish guidelines that assist students in making responsible decisions as they select attire that is appropriate for school.

  • The resulting curb-to-curb width is 34-foot.The number of piers in the river will be reduced, increasing the opening area and improving the flow characteristics through the bridge.

  • Where applicable, MSD will provide to such Collaborator contact all information regarding the value of the MSD Compound provided for use in the MSD Compound Study as required for such reporting.

  • Collaborator shall ensure that the MSD Compound Study and all related activities are performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP.

  • Each Party shall use reasonable efforts to publish or present scientific papers with respect to the MSD Compound Study in accordance with accepted scientific practice.

Related to MSD Compound

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • 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”).

  • 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.

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

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

  • 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 an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

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

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

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • 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, but excluding single variable domains (heavy or light) of such antibodies.

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

  • 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.

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

  • 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.

  • 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.

  • 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 (a) containing a Licensed Product together with one or more other active ingredients, or (b) with one or more products, devices, pieces of equipment or components, but sold for an integrated price (e.g., with the purchase of one product the customer gets a coupon for the other) or for a single price.

  • Nicotine product means the same as that term is defined in Section 76-10-101.