Confirmed Hit definition

Confirmed Hit means any *** or ***, other than an Initial Included Collaboration Target, that: (i) is identified by FivePrime and/or BMS during the performance of the Research Program during the Research Term as a Hit; (ii) meets the confirmatory criteria determined by the Working Group (and approved by the JRC), including, for example, confirmation with recombinant protein or through specificity or affinity analyses or activity in a secondary assay; and (iii) is not an Excluded Protein.
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Confirmed Hit means a Protein that is initially identified as a hit from a Screening Assay as a result of screening all or a portion of the FivePrime Library and is confirmed by the Working Group based upon the results of follow-up activities performed under the Research Plan.
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Confirmed Hit has the meaning given in Section 2.5(a).
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Examples of Confirmed Hit in a sentence

  • Either Party may publish manuscripts, abstracts, presentations or other articles in scientific journals or at scientific conferences relating to any Confirmed Hit or Collaboration Target, upon the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed.

  • The Bonds do not restrict the Issuer from incurring additional debt.

  • Upon FivePrime’s receipt of such notice, such Confirmed Hit shall automatically become an Included Collaboration Target.

  • Although Excluded Proteins may be included in the protein libraries FivePrime screens under the Research Program, notwithstanding any other provision of this Agreement or any Research Plan to the contrary, no Excluded Protein shall be deemed a Confirmed Hit under this Agreement, and FivePrime shall have no obligation to disclose to BMS any Third Party Protein that may be identified as a hit as a result of any screening or follow-up confirmation activities under the Research Program.

  • BMS shall have the right to use any and all Confirmed Hit Data solely for the purpose of evaluating (including with respect to safety or regulatory concerns) the relevant Confirmed Hit so as to determine whether or not BMS will exercise its Option with respect to such Confirmed Hit.

  • For each Confirmed Hit that BMS selects as an Additional Collaboration Target, BMS shall pay to FivePrime a non- refundable, non-creditable payment of *** within *** calendar days after BMS delivers to FivePrime the written notice identifying such Confirmed Hit as an Additional Collaboration Target pursuant to Section 4.2.2 (the “Selection Fee”).

  • During the applicable Claiming Option Period (as defined in Section 4.2.3), UCB shall have an exclusive option (even as to FivePrime) to select a Confirmed Hit for evaluation and further development as a UCB Reserved Protein (each such option, a “Claiming Option”).

  • UCB shall have the right to exercise its Claiming Option at any time prior to the expiration of the applicable Claiming Option Period by providing written notice to FivePrime to that effect and thereafter paying FivePrime the Optioning Fee pursuant to Section 8.2.1. The term “Claiming Option Period” with respect to a Confirmed Hit means the ***-day period following the date on which FivePrime delivers to UCB the Confirmed Hit Data with respect to such Confirmed Hit.

  • From time to time after the Effective Date, FivePrime may add, subtract or substitute an Excluded Protein on the Excluded Protein List, provided that FivePrime may not add to the Excluded Protein List any Protein that (i) is, as of the date such Protein is to be added, a Confirmed Hit, or Collaboration Target, or (ii) was identified as a Hit less than *** days prior to the date such Protein is to be added, unless and until such Protein becomes a Non-Selected Target or a Terminated Target.

  • Subject to the license grants to GSK under this Agreement, as between the Parties, Chimera shall own and retain all right,title and interest in and to: (i) Chimera Background IP and (ii) any improvement, modification or enhancement to Chimera Background IP [***], and that does not claim, Cover or relate to the use or composition of any Screening Hit, Program Hit or Confirmed Hit ((i) and (ii), collectively “Chimera IP”).


More Definitions of Confirmed Hit

Confirmed Hit means a Protein that is initially identified as a hit from a Screening Assay as a result of screening all or a portion of the FivePrime Library and is confirmed by the Working Group based upon the results of follow-up activities performed under the Research Plan; provided, h owever, that no UCB Exempted Protein or *** that is identified as a hit from any such Screening Assay shall qualify as a “Confirmed Hit” under this Agreement.”
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Related to Confirmed Hit

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • 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.

  • GSK will have the meaning set forth in the Preamble.

  • 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.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • 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)).

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Stage-Four Advanced, Metastatic Cancer means a cancer that has spread from the primary or original site of the cancer to nearby tissues, lymph nodes, or other areas or parts of the body.

  • hit means the existence of a match or matches established by the Central System by comparison between biometric […] data recorded in the computerised central database and those transmitted by a Member State with regard to a person, without prejudice to the requirement that Member States shall immediately check the results of the comparison pursuant to Article 26(4);

  • Non-Administrator Substance Use Disorder Treatment Facility means a Substance Use Disorder Treatment Facility that does not meet the definition of an Administrator Substance Use Disorder Treatment Facility.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Collaborating physician means the physician who,

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Collaborative pharmacy practice agreement means a written and signed

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • ISIS means the department’s individualized services information system.

  • Collaborative matter means a dispute, transaction, claim, problem, or issue for resolution, including a dispute, claim, or issue in a proceeding, that is described in a collaborative law participation agreement and arises under the family or domestic relations law of this state, including any of the following:

  • 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.

  • Electronic Funds Transfer (EFT) indicator means a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the commercial, nonprofit, or Government entity to establish additional System for Award Management records for identifying alternative EFT accounts (see subpart 32.11) for the same entity.

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and

  • 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.

  • POC (Proof of Concept) means testing the Software for evaluation purposes.

  • Cardiopulmonary resuscitation or "CPR" means artificial ventilation or external

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Opioid antagonist means a drug that binds to opioid

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.