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 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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Examples of Cancer Indication in a sentence

  • As used in Article 5, the term "Cancer Indication" shall refer to any Major Tumor Indication or any Other Oncology Indication.

  • In this, NHSI has unified its approach for overseeing providers irrespective of their legal form.

  • Because the structure of the computation in Protocol 3 is the same as in Protocol 2 and primarily only ZKPKs have been added (that have corresponding simulators in the ideal model), we defer the proof to the full version of this work.Before we conclude this section, let us comment on the possibility of using OT extensions in combination with certi- fied inputs.

  • The EMA Did Not Approved Zydelig As First-Line Treatment For A Hematologic Cancer Indication 15 IV.

  • 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.

  • Milestone 3(b) expressly separates the concepts of approval, line of therapy, and Hematologic Cancer Indication, referring to “Regulatory Approval .

  • 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.

  • Contingent liabilities, commitments and guarantees Notes to standalone financial statements (Contd.)(All amounts are in Indian Rupees (₹), unless otherwise stated) 38 Segment reportingThe company is primarily in the business of real estate development and related activities including construction.

  • A700 (817:15–818:6) (Hawkins).The Agreement also provides alternative triggers for the milestone, including a provision providing for the $50 million milestone (and potentially other milestones as well) to be paid if $1 billion in annual sales occurs, A131–32, even if regulatory approval for a Hematologic Cancer Indication has not occurred.


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 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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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.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Competing Product means [***].

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • 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.

  • 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.

  • 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 trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Clinical Trial means any human clinical trial of a Product.

  • 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 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 or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.