R&D Candidate definition

R&D Candidate has the meaning given to such term in the Collaboration Agreement.
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R&D Candidate. Research and Development Candidate or R&D Candidate shall mean any Antibody to a Specific Target (other than a CAT Exclusive Antibody) that the Joint Steering Committee designates as a R&D Candidate by determining that such Antibody should proceed with GLP toxicology studies.
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Examples of R&D Candidate in a sentence

  • Within [***] after the date first written above, the Parties shall prepare a written annual research plan (the "Annual Research Plan") for the Research activities to be conducted with respect to each Specific Target, any Antibody candidate which bind thereto and each R&D Candidate.

  • Within [***] after the date first written above, ELAN and CAT shall establish a "Joint Steering Committee" or "JSC" to oversee and direct the conduct of Research and the Development of each Specific Target and R&D Candidate and to oversee and coordinate those activities that are necessary for the successful Commercialization for a Collaboration Product in the Territory, as further described below in this Agreement.

  • An R&D Candidate shall remain in the Development Program until such time as (i) the JSC determines that such R&D Candidate should be returned to the Research Program for the conduct of further Research, (ii) such R&D Candidate is dropped from the Development Program or (iii) such R&D Candidate becomes a Collaboration Product.

  • Each Party shall use, and shall cause its permitted Third Party Sublicensees to use, commercially reasonable and diligent efforts to disclose to the other Party all material information relating to any R&D Candidate or Collaboration Product promptly after it is learned or its materiality appreciated.

  • From time to time, either Party may request an affirmation from the other Party of the status of an Antibody as either an CAT Exclusive Antibody or an R&D Candidate.

  • If the Research to be conducted under this Agreement, the Development of any R&D Candidate, Manufacture of Clinical Supplies or Collaboration Products and/or Commercialization of any Collaboration Product is alleged by a Third Party to infringe a Third Party's patent or misappropriate a Third Party's Know How, the Party becoming aware of such allegation shall promptly notify the other Party thereof, in writing, reasonably detailing the claim.

  • The responsibility for performing clinical studies of each R&D Candidate will be assigned to CAT, ELAN and/or Third Party contractors selected by the JSC in accordance with this Section.

  • Notwithstanding the foregoing, to the extent CAT has or receives any information regarding any adverse drug experience which may be related to the use of any R&D Candidate or Collaboration Product, CAT shall promptly provide ELAN with all such information in accordance with the adverse event reporting procedures to be established by the JSC no later than [***] (as may be amended from time to time upon mutual agreement of the Parties).

  • On a Collaboration Product-by-Collaboration Product basis, not later than [***] after commencement of the first Phase III Clinical Trial of a R&D Candidate in the Territory, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less than[***]) plan for Commercializing the Collaboration Product in the Territory (the "Commercialization Plan"), which plan shall include without limitation [***].

  • The term of this Agreement will commence on the Effective Date and, unless earlier terminated as provided in Article 13 or this Article 12, shall continue in full force and effect on a Collaboration Product-by-Collaboration Product and country-by-country basis for so long as any R&D Candidate is being Developed or any Collaboration Product is being sold under this Agreement.

Related to R&D 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.

  • 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 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.

  • 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)).

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

  • Licensed Compound means [***].

  • 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.

  • 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.

  • 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;

  • 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.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Research Program has the meaning set forth in Section 2.1.

  • Research Program Term has the meaning set forth in Section 2.2.

  • 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.

  • GSK has the meaning set forth in the preamble.

  • 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.

  • 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);

  • 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.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • 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.

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

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • 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.