Backup Candidate definition

Backup Candidate shall have the meaning set forth in Section 5.10.1.
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Backup Candidate means any Designated Antibody or ADC Product that: (a) is not a Collaboration Product and (b) binds specifically to a Designated Antigen [***].
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Backup Candidate has the meaning given in Section 3.2.
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Examples of Backup Candidate in a sentence

  • If Affimed fails to successfully develop the Development Candidate and Back-up Candidate to meet the specifications designated as “acceptable” for Xxxxx X-0 in the Development Plan prior to the expiration of the Maximum Efforts Period applicable to Phase C, it shall provide to the Company and Xxxxxxx notice thereof on or before the end of such Maximum Efforts Period.

  • The goal of Phase B is to (i) further characterize the Lead Candidates selected by the Company (or Xxxxxxx, as applicable) pursuant to Section 2.6 (including following the proceeding in Section 5.4, if applicable) to enable the Company to select one Development Candidate and one Back-up Candidate for production evaluation (“Xxxxx X-0”) and (ii) to evaluate the selected Development Candidate and Back-up Candidate for production purposes (“Xxxxx X-0”).

  • For the avoidance of doubt, if a Unilateral Product is replaced by a Back-up Candidate only such milestones not already paid for the Unilateral Product shall become payable for the Back-up Candidate.

  • Licensor shall in no event be required to offer to Licensee as a Backup Candidate any Targeted AIM that is then under clinical development for any Retained Indication by Licensor or any of its Affiliates or licensees.

  • Codiak will only be responsible for the Development Costs of [***] Backup Candidate for each of the first [***] Development Candidates up to and including any non-GLP toxicology studies performed with respect to such Backup Candidate.

  • During Phase B-2 Affimed shall seek to further develop the Development Candidate and Back-up Candidate to meet the specifications designated as “acceptable” for Xxxxx X-0 in the Development Plan by performing each of its obligations under the Development Plan for Phase B-2.

  • Except for the provisions of Clauses 4.3(A)(1), 4.3(A)(2) and 4.3(B)(1), if the Back-up Candidate is Developed and Commercialised in accordance with this Clause 4.6 it shall, unless otherwise agreed in writing, be subject to all of the other terms and conditions of this Agreement which are applicable to Licensed Product.

  • Add to section 21-2.03C:Compaction of the topsoil mix will comply with section 19-5.03C.

  • As set forth in the Jazz Collaboration Agreement, early development will also include different engineered exosomes directed to the same target (each, a Backup Candidate).

  • If Xxxxxxx wishes to Develop and Commercialize the Back-up Candidate (in addition to or instead of HuMax-CD38), Xxxxxxx shall notify Genmab of the same and the JSC shall discuss and agree the Development Plan for the Back-up Candidate.


More Definitions of Backup Candidate

Backup Candidate means a Small Molecule pharmaceutical product candidate having a primary mechanism of action through inhibition of beta-secretase that, at any time during the Backup Term (a) is Controlled by Eisai and/or its Affiliates and (b) has initiated or has been evaluated in IND-enabling toxicology studies, but for which Eisai has not, as of the Backup Trigger Date, commenced evaluation in a Phase II Clinical Study or evaluated in a Phase II Clinical Study.
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Related to Backup Candidate

  • 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.

  • 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.

  • Replacement Candidate means any Candidate Introduced by the Agency to the Client to fill the Engagement following the Introduction of another Candidate whose Engagement either did not commence or was terminated during the first 12 weeks of the Engagement;

  • 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.

  • Independent candidate means any candidate who claims not to be affiliated with a political party, and whose name has been certified on the office-type ballot at a general or special election through the filing of a statement of candidacy and nominating petition, as prescribed in section 3513.257 of the Revised Code.

  • 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.

  • 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)).

  • continuing candidate means any candidate not deemed to be elected, and not excluded,

  • 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);

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

  • Valid write-in candidate means a candidate who has qualified as a write-in

  • 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”).

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Candidate means the person Introduced by the Agency to the Client for an Engagement including any officer, employee or other representative of the Candidate if the Candidate is a corporate body, and members of the Agency’s own staff;

  • 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.

  • Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed 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.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • 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).

  • Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications, or derivatives thereof, but excluding single variable domains (heavy or light) of such antibodies.

  • Exempt compound means the same as defined in Rule 2.

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

  • 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.

  • 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.