Cancer Indication definition

Cancer Indication means any and all Indications for cancer or metastasis.
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Cancer Indication means any Sarcoma Indication, Major Cancer Indication, or Other Cancer Indication.
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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

  • ARIAD shall have an option (the “Co-Promotion Option”) to Co-Promote each Product for any Cancer Indication in the U.S. Territory (the “Co-Promotion Territory”) in accordance with this Section 3.12.2 (each such Product, a “Co-Promoted Product”).

  • Milestone Event for Cancer Product in Cancer Field Milestone Payment for First Cancer Indication Milestone Payment for Second Cancer Indication [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For clarity the identity of the “First Cancer Indication” and the “Second Cancer Indication” shall be separately determined for each milestone event based solely upon the order in which such milestone event is achieved.

  • For further clarity, if Medarex exercises its Co-Promotion Option with respect to an Additional Product for a Cancer Indication, such Additional Product shall be a Co-Promotion Product only with respect to all Cancer Indications, and not with respect to any Secondary Milestone Indication or [*****] Indication unless and until Medarex exercises its Co-Promotion Option with respect thereto pursuant to the preceding sentence.

  • Such notice for any Cancer Indication shall specify the percentage of Detailing efforts (by FTE) to be provided by ARIAD in Co-Promoting such Co-Promoted Product (“Basic Detail Percentage”); provided, that, under no circumstances shall the Basic Detail Percentage be more than twenty percent (20%).

  • For further clarity, if Medarex exercises its Co-Promotion Option with respect to the Lead Product for a Cancer Indication, such Product shall be a Co-Promotion Product only with respect to all Cancer Indications, and not with respect to any Secondary Milestone Indication or [*****] Indication unless and until Medarex exercises its Co-Promotion Option with respect thereto pursuant to the preceding sentence.

  • Neither Party shall, unless expressly approved by the JDC, have the right to conduct a Clinical Trial for a Cancer Indication that is not a New Cancer Indication.

  • Either Party may at any time propose to the JDC a Clinical Trial of a Licensed Product for a Cancer Indication for the treatment of a type of tumor that is not already included in the Global Development Plan, and is not a type of tumor that is within the scope of an approved Cancer Indication for a Licensed Product that has received Commercialization Regulatory Approval (a “New Cancer Indication”).

  • In the event MERCK exercises an Opt-Out Right on any occasion for Late Stage Clinical Trial(s) proposed in a Clinical Trial Proposal submitted by ARIAD for any Major Cancer Indication, and ARIAD proceeds with the Late Stage Clinical Trial(s) for such Major Cancer Indication, then upon subsequent FDA approval in the United States of the Product for that Major Cancer for which MERCK exercised its Opt-Out Right, MERCK Revenue Sharing Percentage shall be [***] percent ([***]%).

  • 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.

  • 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).


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.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • 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.

  • 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 or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Second Indication means [***].

  • 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.

  • 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.

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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 human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Licensed Compound means [***].

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

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