Initial Compounds definition

Initial Compounds shall have the meaning given in Section 2.2.2.
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Initial Compounds means the Compounds referred to by Lilly and/or Shionogi as [***].
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Initial Compounds means the Compounds referred to by Lilly and/or Shionogi as S-5920/LY315920, S3013/LY333013 or RSC-3388.
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Examples of Initial Compounds in a sentence

  • In addition at any time during the Research Term, EYETECH shall have the right to request the JRC to include into the Research Program an effort to discover Aptamer Equivalents of ARCHEMIX Initial Compounds that have not become Program Compounds, and the JRC shall approve the inclusion of such Aptamer Equivalents which then becomes a Program Compound unless there exists a compelling scientific reason to refuse such approval.

  • At any time during the Research Term upon EYETECH’S request, ARCHEMIX shall provide updates to EYETECH with respect to the development status of the ARCHEMIX Initial Compounds which have not become Program Compounds, and EYETECH and ARCHEMIX may, at ARCHEMIX’s sole option, agree through the JRC to include into the Program such ARCHEMIX Initial Compounds.

  • If Anthera or its Affiliates or sublicensees do not [***] for a Licensed Product containing one of the Initial Compounds within [***] after the Effective Date, Shionogi and Lilly shall have the right to terminate Anthera’s license rights with respect to all Licensed Products containing an Initial Compound effective upon written notice.

  • If Anthera or its Affiliates or sublicensees do not [***] for a Licensed Product containing one of the Initial Compounds within [***] after the Effective Date, Shionogi and Lilly shall have the right to terminate Anthera’s license rights with respect to all Licensed Products containing any Initial Compound in accordance with Section 9.2(b).

  • Notwithstanding the foregoing, EYETECH shall not have the right to audit or copy any materials that relate to Aptamers that do not, or have been determined not to, have utility in the Field or that become Refused Candidates or are ARCHEMIX Initial Compounds or ARCHEMIX Additional Compounds that have not been designated as Program Compounds.

  • Telik shall provide such Initial Compounds in quantities of approximately [ * ] per Initial Compound, per Selected Target.

  • In addition, following Theravance’s receipt of Janssen’s written request made within [***] of receipt of the Triggering Data Package After Phase 2, Theravance shall, within [***] of such request, provide Janssen with any additional information within Theravance’s Control that is reasonably requested by Janssen with respect to the Initial Compounds or the Initial Product.

  • Within [ * ] of the Effective Date, the Parties shall select an initial set of [ * ] Compounds from the Tularik Library (the "Initial Compounds") that the Parties believe [*].

  • Anything in this Section 2.2.2 to the contrary notwithstanding, the Initial Compounds selected by the Parties shall consist of: [ * ].

  • Of the ARCHEMIX Initial Compounds, ARCHEMIX will identify up to [***] ARCHEMIX Initial Compounds against up to [***] targets for immediate consideration by the JRC (“ARCHEMIX Early Decision Initial Compounds”).


More Definitions of Initial Compounds

Initial Compounds means the Compounds referred to by Lilly and/or Shionogi as S-5920/LY315920, S3013/LY333013 or RSC-3388. 1.30 “Injectable Formulation” means a parenteral formulation of a Licensed Product that is administered by injection; referring particularly to the introduction of substances by means of intravenous, subcutaneous, intramuscular, or intramedullary injection. 1.31 “Know-How” means all tangible or intangible technical, scientific, and other know-how, Biological Materials, data, information, trade secrets, assays, ideas, formulae,
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Initial Compounds means (a) the [***], and (b) the [***]. For clarity, in the circumstances of a Reload Compound under Section 3.2, with respect to any Initial Compound selected as a PCC by the Parties for Pre-Clinical Development and subsequently agreed by the Parties to cease Development under Section 3.2, any improvements, modifications or upgrades of such ceased Initial Compound confirmed and accepted by the Parties as a Reload Compound shall forthwith not be considered as an Initial Compound.
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Related to Initial Compounds

  • 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: (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”).

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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).

  • Licensed Compound means [***].

  • 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.

  • Compounds means any or all of the following chemicals, as the context requires:

  • 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.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • 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 Milestone is defined in Section 5.3.

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

  • 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.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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.

  • 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).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • 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.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.