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

  • 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.

  • 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.

  • 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”).

  • 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.

  • Any such Back-up Compound for which NOVARTIS has exercised its Development Election under Section 7.4 shall become a "Drug Product Candidate Back-up Candidate" subject to the terms and conditions of this Agreement.

  • 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.

  • 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.

  • 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.

  • Any such Back-up Compound for which NOVARTIS has exercised its CONFIDENTIAL TREATMENT REQUESTED Development Election under this subsection (d) shall become a "Drug Product Candidate Back-up Candidate" subject to the terms and conditions of the License Agreement.


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 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.

  • 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)).

  • 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 [***].

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • 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, 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 Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

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

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • 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.

  • 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.