Research Indication definition

Research Indication means an Indication for which Products are being developed under the Research Program prior to achievement of the Acceptance Criteria. The initial Research Indications are listed in Exhibit E attached hereto, which shall be updated by the Parties as Research Indications are added or removed.
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Research Indication means each of: (a) Muscle Diseases; (b) ***, in the event GSK expands the Research Program into ***; and (c) any Other Indication agreed upon by the Parties pursuant to Section 3.3.2(c).
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Examples of Research Indication in a sentence

  • Upon achievement of the Acceptance Criteria for a Product for a specific Research Indication, Licensee may elect, by providing Penn with formal written notice, to convert such Research Indication to a Licensed Indication within [***], provided, however, that Licensee shall not be obligated to make an election decision for more than one (1) Research Indication in any [***] time period following the achievement of the Acceptance Criteria for the first Product as determined by the JSC [***].

  • During the Research Term, on a Research Indication-by-Research Indication basis, the JSC shall determine if the Acceptance Criteria have been achieved for a Product for such Research Indication.

  • Each Working Group for a particular Research Indication shall also serve as a forum through which the Parties will share day-to-day operational information regarding the Research Program for such Research Indication, all in accordance with the terms of this Agreement.

  • Upon receipt of such notice of termination for any Research Program for any Research Indication, FivePrime shall use reasonable efforts to wind down the efforts expended by FivePrime on such Research Program for such Research Indication, and GSK shall remain responsible for all liabilities and obligations incurred or accrued as provided in Section 6.2 for a terminated Research Program with respect to a particular Research Indication prior to the effective date of such termination.

  • Each Party shall establish, for each Research Indication, a team (the “Project Team”) that shall work together with the other Party’s Project Team to form a single group (each, a “Working Group”) that is responsible for carrying out the activities under the Research Plan for such Research Indication.

  • For the avoidance the doubt, during the GSK Reverted Target Exclusivity Period, GSK and its Affiliates may, on its or their own, conduct any internal research or development activities with respect to any Reverted Target for indications other than the Reverted Target Research Indication.

  • FivePrime may research and develop such Reverted Target for any indication (including the Reverted Target Research Indication) in connection with a FivePrime internal program during the Research Program Term, but shall not license to a Third Party any rights with respect to such Reverted Target in the Reverted Target Research Indication until the expiration of the Research Program Term (the “FivePrime Reverted Target Exclusivity Period”).

  • Each Working Group for a particular Research Indication shall make decisions on day-to-day operational matters, make decisions on which Hits shall be subject to further assays to confirm selection of such Hits as Offered Hits, as provided in Section 3.4.1(b), and conduct the activities under the Research Plan, in each case for such Research Indication.

  • If, however, GSK elects not to exercise its Claiming Option with respect to such Hit, then such Hit shall not be deemed a Reverted Target as that term is defined herein but rather shall thereafter be referred to as a “Non-Selected Target” and such Non-Selected Target shall be considered outside of the scope of this Agreement and the Research Program with respect to the particular Research Indication for which the Hit was identified by FivePrime.

  • FivePrime shall offer to GSK any and all Hits from a Screening Assay that have been further confirmed, to the extent confirmation is feasible and reasonable, to exhibit in vivo activity or Hits that, by virtue of activity in medically relevant, secondary in vitro assays, are thought to have reasonable and realistic potential as therapeutics or targets of therapeutics for a Research Indication (each such Hit, an “Offered Hit”).

Related to Research Indication

  • 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.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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.

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

  • 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.

  • Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • 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”).

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

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • 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.

  • 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.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • 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.

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

  • Licensed Field means [***].

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

  • 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.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

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

  • Licensed Territory means worldwide.

  • Development Plan has the meaning set forth in Section 3.2.

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

  • 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.