CNS Indication definition

CNS Indication means any condition, disorder and/or disease primarily involving the central nervous system in humans or animals, and for which therapeutic treatment with a compound would require crossing of the blood-brain barrier by such compound.
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CNS Indication shall have the meaning set forth in Appendix A.
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CNS Indication means any disease, disorder or condition of the central nervous system in humans, including, without limitation, (i) [***] (i.e., [***], [***]), [***] (i.e., [***], [***], [***]), [***] (i.e., [***], [***]), [***] (i.e., [***]), and [***], [***], and (ii) [***], [***], [***], sporadic Alzheimer’s disease, familial Alzheimer’s disease, amyotrophic lateral sclerosis, Xxxxxxxxx’x disease, [***], [***], [***], [***], multiple sclerosis, Huntington’s disease, [***], Dravet syndrome and [***]. Notwithstanding the foregoing, CNS Indication shall not mean (a) any indication in which the treatment, prevention or amelioration of pain in any form would be a primary efficacy endpoint in a clinical trial or (b) any gastrointestinal disorder, non-central nervous system autoimmune disorder or cardiovascular disorder.
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Examples of CNS Indication in a sentence

  • At any time during the Term, each Party has the right to submit a development and commercialization proposal for the Compound in a potential new Orphan CNS Indication (other than the Initial Indications or any then-existing Additional Indications) for review by the JDC and approval or rejection by the CGB in accordance with Article 2.

  • The Joint Discovery Committee shall review select compounds that arise under the Beacon Agreement and are identified by Licensor as having potential utility for a CNS Indication, and decide whether to designate such compound for investigation by the Licensee (each such designated compound, an “ROFN Compound”).

  • In the case of a new Orphan CNS Indication recommended by the JDC, such meeting shall be held [*] following recommendation to the CGB, or as soon as reasonably possible.

  • If approved by the CGB, such new Orphan CNS Indication shall be an “Additional Indication”.

  • TG shall provide Company with written notice (a “New CNS Indication Notice”) of such New CNS Indication for the Product and a brief description of the associated Development activities (the “New CNS Indication Development Activities”) as well as a break-down, in reasonable detail, of the costs actually incurred and likely to be incurred in the future by or on behalf of TG following ​ ​ the Effective Date in connection with the performance of the applicable New CNS Indication Development Activities.


More Definitions of CNS Indication

CNS Indication means Schizophrenia and all other CNS diseases including, but not limited to, psychotic disorders, depression, anxiety, sleep disorders, pain, dementia, Alzheimer disease, cognitive disorders and attention disorders (ADHD).
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CNS Indication means any disease, disorder, or condition primarily affecting or manifesting in the brain, spinal cord, or peripheral nervous system (with the exception of and not including the enteric nervous system), including neurological, psychiatric, neuropsychiatric, pain, mental, and behavioral indications. Without limiting the foregoing, CNS Indications includes all indications within the ICD-10 code range of F01-F99 and G01-99. “CNS Symptoms” means a physiologically expressed symptom primarily manifesting in the brain, spinal cord or peripheral nervous system (with the exception of and not including the enteric nervous system) that is secondary to non-CNS Indications. CNS Indications shall include CNS Symptoms for the purposes of this Agreement. For clarity, indications that do not fall within the first sentence of this definition are not deemed to be CNS Indications by nature of the presence of CNS Symptoms. “Closing” means the closing of the transactions contemplated by this Agreement. “Combination Product” has the meaning set forth in the definition of “Net Sales”. “Code” means the Internal Revenue Code of 1986, as amended. “Confidential Information” means any and all Information that (a) is disclosed by one Party or its Affiliates to the other Party or its Affiliates under or in connection with this Agreement, whether in oral, written, graphic, or electronic form, and (b) concerns the Products, the Monash License (or the inventions disclosed or claimed therein), any Transferred Asset (including the Glyph Technology and the Monash License), which, in the case of the Confidential Information described in this subsection (b), will be deemed Seaport’s Confidential Information notwithstanding any prior access or knowledge by PureTech or any of its Controlled Affiliates, except that any such Confidential Information to the extent primarily relating to any Identified Product Concepts (and not any then-existing Products of Seaport) that is disclosed by PureTech to Seaport in furtherance of exercise of PureTech’s rights with respect to a PureTech License will be deemed PureTech’s Confidential Information notwithstanding any prior access or knowledge by Seaport or any of its Controlled Affiliates. “Contract” means any written or oral agreement, contract, subcontract, settlement agreement, lease, sublease, binding understanding, instrument, note, option, bond, mortgage, indenture, trust document, loan or credit agreement, license, sublicense, insurance policy or legally...
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Related to CNS Indication

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

  • Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.

  • Second Indication means [***].

  • 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.

  • 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.

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

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • 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.

  • 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.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

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

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • 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.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such 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.

  • 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 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.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.