ALD518 definition

ALD518 means the Alder proprietary IL-6 Compound designated as “ALD518” and having the amino acid sequence set forth on Exhibit A, as well as any fragment, derivative or subunit thereof that is also an IL-6 Compound.

Examples of ALD518 in a sentence

  • A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate.

  • A humanized anti-IL-6 antibody (ALD518) in non-small cell lung cancer.

  • Exhibit A Amino Acid Sequence of ALD518 [***] [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

  • The Mayor and Cabinet will consider any recommendations from the Overview and Scrutiny Committee in January 2020 before finalising the budget in February 2020.

  • Notwithstanding BMS’ final decision-making authority as set out in Section 3.2(e), if a Clinical Trial or non-clinical study [***] proposed by BMS for a Licensed Product is one which Alder reasonably believes is likely to have a material adverse impact on the target product profile for the Cancer Product containing ALD518 in the Cancer Field, Alder shall so inform BMS, and provide BMS in writing an explanation and basis for such belief.

  • MCE plans to increase the rate of enrolled participants through collecting this information not as a prerequisite, but at the conclusion of the program.

  • BMS , by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to pursue an active and ongoing Development program for the ALD518 LF Product for the RA Indication in the Licensed Territory for the purpose of obtaining Regulatory Approval in each of the Major Markets in accordance with the Licensed Field Development Plan.

  • Annual Net Sales in the Licensed Territory (Determined Separately for Each Licensed Product) Base Royalty Rate [***] [***] [***] [***] [***] [***] [***] [***] By way of example, if the aggregate Net Sales of an ALD518 LF Product in the Licensed Territory in a particular Calendar Year is $2.7 billion, the amount of royalties payable hereunder shall be calculated as follows (subject to any applicable reductions under this Section 8.6): [***].

  • BMS and Alder desire to enter into a collaboration for the continued development and, if successful, regulatory approval for and commercialization of products containing ALD518 and/or back up products thereto, in both the Licensed Field (as further defined below) and the Cancer Field (as defined below) all in accordance with the terms and conditions set forth herein below.

  • Exhibit C Initial Cancer Development Plan Non-clinical studies in cancer: [***] studies to investigate the effect of ALD518 on the sensitivity of cancer cell lines/transplants to cancer chemotherapeutic agents including but not limited to [***].

Related to ALD518

  • Cannabidiol means a finished preparation containing, of its total cannabinoid content, at least 98 percent cannabidiol and not more than 0.90 percent tetrahydrocannabinol by volume that has been extracted from marijuana or synthesized in a laboratory.

  • Parenteral means a method of drug delivery injected into body tissues but not via the gastrointestinal tract.

  • haemophilia means an inheritable disease, usually affecting only male but transmitted by women to their male children, characterised by loss or impairment of the normal clotting ability of blood so that a minor would may result in fatal bleeding;

  • Opioid antidote means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. “Opioid antidote” includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods.

  • Pistol means any firearm with a barrel less than sixteen inches in length, or is designed to be held and fired by the use of a single hand.

  • HBV means hepatitis B virus.

  • Pyrolysis means the thermal degradation of a substance in the absence of any oxidising agent, which does not form part of the substance itself, to produce char and gas and/or liquid; and

  • thalassemia means a group of inherited disorders characterised by reduced or absent amounts of haemoglobin.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Cannabinoid extract means a substance obtained by separating cannabinoids from marijuana by:

  • Medical marijuana concentrate means a specific subset of Medical Marijuana that was produced by extracting Cannabinoids from Medical Marijuana. Categories of Medical Marijuana Concentrate include Water-Based Medical Marijuana Concentrate, Food-Based Medical Marijuana Concentrate, Solvent-Based Medical Marijuana Concentrate, and Heat/Pressure- Based Medical Marijuana Concentrate.

  • Antidote means the most practical immediate treatment in case of poisoning and includes first aid treatment.

  • Bio-medical waste means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals or in research activities pertaining thereto or in the production or testing of biologicals, and including categories mentioned in Schedule I;

  • cannabis resin means the separated resin, whether crude or purified, obtained from any plant of the genus Cannabis;

  • Salmonid means of, belonging to, or characteristic of the family Salmonidae, which includes the salmon, trout, and whitefish.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Cannabis waste means waste that is not hazardous waste, as defined in Public Resources Code section 40141, that contains cannabis and that has been made unusable and unrecognizable in the manner prescribed in sections 5054 and 5055 of this division.

  • Cannabinoid means any of the chemical compounds that are the active constituents of marijuana.

  • Tetrahydrocannabinol means the natural or synthetic equivalents of the substances contained in the plant, or in the resinous extractives of, Cannabis sativa, or any synthetic substances, compounds, salts, or derivatives of the plant or chemicals and their isomers with similar chemical structure and pharmacological activity.

  • coronavirus means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • Prosthesis means an artificial substitute for a missing body part.

  • Biomedical Waste means biomedical waste as defined in the Ontario Ministry of the Environment Guideline C-4 entitled “The Management of Biomedical Waste in Ontario” dated April 1994, as amended from time to time;

  • Wild animal means any mammal, bird, fish, or other creature of a wild nature endowed with sensation and the power of voluntary motion.

  • Medical management technique means a practice which is used to control the cost or utilization of health care services or prescription drug use. The term includes, without limitation, the use of step therapy, prior authorization or categorizing drugs and devices based on cost, type or method of administration.