Initial Enzyme definition

Initial Enzyme means any GSK Initial Enzyme or Codexis Initial Enzyme contributed to a Project which is selected to undergo Initial Enzyme Optimisation.
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Initial Enzyme means the [***] contributed to a Technology Transfer Project which is selected to undergo Initial Enzyme Optimization. Once an Initial Enzyme is selected, such selection may only be changed by mutual written consent of the Parties.
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Initial Enzyme means the single Merck Initial Enzyme or Codexis Initial Enzyme contributed to a Technology Transfer Project which is selected to undergo Initial Enzyme Optimization. Once an Initial Enzyme is selected, such selection may only be changed by mutual written consent of the Parties.
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Examples of Initial Enzyme in a sentence

  • Initiation of a Project following selection of an Initial Enzyme for Initial Enzyme Optimization.

  • The basis for such decision shall be discussed by the Patent Committee pursuant to Section 5.2 and Codexis shall thereupon have the right (but not the obligation) to assume responsibility for Prosecution of such GSK Patent at Codexis’ expense, and with counsel of Codexis’ choosing, except (a) any GSK Patent covering any Licensed Product; and (b) any GSK Patent relating to any GSK Compound, any GSK Existing Pharmaceutical Product, any GSK Initial Enzyme, and/or any GSK Selected Enzyme.

  • Once an Initial Enzyme is selected, such selection may only be changed by mutual written consent of the Parties.


More Definitions of Initial Enzyme

Initial Enzyme means the single Merck Initial Enzyme or Codexis Initial Enzyme contributed to a Technology Transfer Project which is selected to undergo Initial Enzyme Optimization. Once an Initial Enzyme is selected, such selection may only be changed by mutual written consent of the Parties. 1.57 “Initial Enzyme Optimization” means the process of optimizing an Initial Enzyme. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. - 7 – Execution Version 1.58 “Initial Technology Transfer Inventory” means all of the items set out in Appendices I, II and III of the Technology Transfer Plan. 1.59 “Initiation Period” means the period beginning on the TT Term Expiration Date and ending on the earlier of (a) the date that is ten (10) years after the TT Term Expiration Date, or (b) the termination of this Agreement. 1.60 “In-License Agreements” means all agreements pursuant to which any Licensed IP is licensed or sublicensed to Codexis from a Third Party and which are listed in Exhibit 1.60. 1.61 “In-Licensed IP” means the In-Licensed Patents and any In-Licensed Know-How. 1.62 “In-Licensed Know-How” means all Know-How of Third Parties Controlled by Codexis as of the Effective Date and licensed to Codexis pursuant to the In-License Agreements, in each case that Covers the Codexis Documentation, the Codexis Materials, Know-How related to the operation of the Codexis Software (but excluding the Codexis Software itself) or the practice of the Platform Technology. 1.63 “In-Licensed Patents” means the Patents set forth on Exhibit 1.63. 1.64 “Intellectual Property Rights” means Patents, Know-How and copyrights, including all applications for registration for the foregoing and all other similar proprietary rights as may exist anywhere in the world. 1.65 “Internal Research Purposes” means scientific research programs in the animal and/or human healthcare field conducted internally by Merck or its Affiliates, which are specifically directed to the purposes of their internal research, but excluding the discovery of novel Therapeutics [***]. 1.66 “Invention” means any discovery, invention, contribution, method, finding, or improvement, whether or not patentable, and all related Know-How. 1.67 “Invoice” means any invoice submitted to Merck by Codexis under this Agreement, produced in accordance with Merck’s processing requirements. 1.68 “Kno...
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Related to Initial Enzyme

  • 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).

  • 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.

  • 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.

  • 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 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 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 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)).

  • 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.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • 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.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • (3) PROGRAM.—The term program’ means

  • 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 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 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).

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

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

  • Development Phase means the period before a vehicle type is type approved.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Research Period means the research period as described in the Commissioned Research Plan. In accordance with the provisions of this Agreement, in the event that the Agreement ended prior to the completion date of the research originally set, the date the Agreement ends shall be read as the research period.

  • 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).

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • 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.