Cancer Indication definition

Cancer Indication means any Sarcoma Indication, Major Cancer Indication, or Other Cancer Indication.
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Cancer Indication means any and all Indications for cancer or metastasis.
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Cancer Indication means an oncological disease or diseases in humans, and/or diseases or medical conditions associated with such an oncological disease in humans.
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Examples of Cancer Indication in a sentence

  • See Karen Carey, Avastin Loses Breast Cancer Indication, 30(1) NATURE BIOTECH.

  • The Swiss National Bank has offered to provide the System with up to $20 million worth of Swiss francs for intervention in New York beginning at the time their markets close,12/17/74-49-which would be 10 a.m. here.

  • Dr. Temple explained in 1991 that because Platinol was known to im- prove survival, the agency’s advisors “felt that it was appropriate that the data be mature enough to conclude that the use of carboplatin would not be associated with worse sur- vival.” Bristol-Myers Squibb’s Paraplatin (Carboplatin) Data Support First-Line Ovarian Cancer Indication Despite Survival Profile Concerns, FDA Finds, PINK SHEET (July 8, 1991).

  • The revised labeling stated that Paraplatin had demonstrated an “equivalent overall survival rate compared to cisplatin when both were given in combination with cyclophosphamide.” Bristol-Myers Squibb’s Paraplatin (Carboplatin) Data Support First-Line Ovarian Cancer Indication Despite Survival Profile Concerns, FDA Finds, supra note 158.

  • Generic Name: Nivolumab Brand Name: Opdivo® Disease area: Lung Cancer Indication: Previously treated adults with locally advanced or metastatic non- squamous NSCLC (nsqNSCLC).

  • Notably, several examples in the record are from Blood—which is published in the United States, “[o]ne of the highest impact hematologic cancer journals,” A522–23 (108:16–19, 110:14–21) (Miller), and the very publication Calistoga used to create the list defining Hematologic Cancer Indication, A509 (55:1–7) (Miller) & A180–83.

  • ARIAD may exercise the Co-Promotion Option for such Product for each Cancer Indication by written notice given to MERCK on or before the date that is [***] ([***]) [***] prior to the Anticipated Launch date (as amended).

  • As such, UCLA breached the UCLA Agreement and PeriRx-RNA Agreements by contractually obligating PeriRx to develop the Lung Cancer Indication while knowing that the lung cancer data was fictitious.

  • Company to Pursue Low-Grade Serous Ovarian Cancer Indication for VS-6766 with Defactinib; On Track to Initiate Discussions with FDA Company Reports $5.0M in Net Product Revenue; With Newly Strengthened Balance Sheet, Company is Well Positioned to Execute on Key Corporate Objectives in 2020 and Beyond BOSTON, MA – May 7, 2020 – Verastem, Inc.

  • For purposes of clarity, the use of the term Indication, if it is a Cancer Indication, in Section 4.2.1(a) above shall refer to a particular tumor type and not to changes in, or expansion of, the regulatory label applicable to a given tumor type.


More Definitions of Cancer Indication

Cancer Indication shall refer to any Major Tumor Indication or any Other Oncology Indication.
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Cancer Indication means a separate and distinct disease or medical condition in humans for which a Product that is in Clinical Trials is intended to treat and/or prevent and/or for which a Product has received Marketing Authorization for such treatment and/or prevention for the following disease and medical conditions: (a) the following * (each, a “Major Tumor Indication”); or (b) * (each, an “Other Cancer Indication”). * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission.
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Related to Cancer Indication

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • 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.

  • Additional Indication means any indication other than the Initial Indication.

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

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

  • Competing Product means […***…].

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

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

  • Second Indication means [***].

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Licensed Compound means [***].

  • 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.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).