Targeted Indications definition

Targeted Indications means the indications listed on Statements of Work attached hereto and incorporated herein by reference.
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Targeted Indications means, collectively, the following Indications: (a) [***] Indications; (b) [***] Indications; (c) [***] Indications; and (d) Non-Cancer Indications.
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Targeted Indications means (a) all human Cancer Indications and (b) any Approved Non-Cancer Indications.
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Examples of Targeted Indications in a sentence

  • The Parties shall review and discuss the Development of the Licensed Compounds in the AN2 Targeted Indications, including planned Pre-PoC Development Activities and AN2’s good faith estimate for the timing of such activities through the JSC (which estimates may be adjusted by AN2 upon notice to the JSC, but no more frequently than semi-annually).

  • During the Term, Brii Bio hereby grants to AN2 a royalty-free, fully paid-up, exclusive license, with the right to grant sublicenses, to use such Data generated by Brii Bio from Development activities conducted under the Brii Bio Development Plan and owned by Brii Bio solely for the further Development and Commercialization of Licensed Products in the AN2 Targeted Indications in the XX0 Xxxxxxxxx.

  • Subject to the Regulatory Transition Plan, DS shall have the sole right and responsibility for furnishing timely notice to the applicable governmental agencies within the Territory of all side effects, drug interactions and other adverse effects identified or suspected with respect to the Licensed Products for the Targeted Indications administered, distributed, marketed and sold under authority of any IND, NDA or Regulatory Approvals issued by such governmental agencies.

  • If Commercialization Regulatory Approval is obtained in the Target Indication that is not in a “niche” Targeted Indication that will materially increase the sale of the Licensed Product, as determined by the JSC as a Joint Decision, then all milestones based on Clinical Trials and Commercialization Regulatory Approval of the Targeted Indication will be due upon receipt of Commercialization Regulatory Approval (unless the relevant number of milestones have been fully paid for other Targeted Indications).

  • Upon Servier’s exercise of the Option to License for a given Product, Servier will use, and will ensure that its Affiliates, Sublicensees and subcontractors use Commercially Reasonable Efforts in Developing and Commercializing the corresponding Product in the Targeted Indications and the Targeted Territory, and are in compliance with the Agreement.

  • For clarity, pursuant to the license grant under this Section 4.1, Brii Bio shall have the right to perform Pre-PoC Development Activities in Brii Bio Targeted Indications in the Licensed Territory to the extent approved by the JSC in accordance with Section 2.2(a).

  • MERCK may conduct research, or may request ARIAD to conduct research (subject to ARIAD’s consent as set forth below), to deliver one (1) or more Rapamycin Derived mTOR Inhibitors in addition to Ridaforolimus which may be Developed as a follow-up compound or simultaneously with Ridaforolimus for Targeted Indications (each such compound, a “Back-Up Compound”).

  • ARQULE shall provide DS with all side effects, drug interactions and other adverse effects identified or suspected with respect to the Licensed Products for the Targeted Indications in Phase 1 Development Activities conducted by ARQULE and any assistance that may be reasonably necessary for DS to comply with all adverse reaction reporting requirements established by, or required under, any applicable IND, NDA or Regulatory Approvals and/or Applicable Laws within the Territory.

  • The personnel database is linked to the payroll database and assures of effective control.

  • Notably, the Targeted Indications do not include any indications for which Acthar is approved or is currently seeking approval.

Related to Targeted Indications

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

  • 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.

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

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

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

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

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

  • 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.

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

  • 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”).

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • 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.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • 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.

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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).

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

  • 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.

  • Second Indication means [***].